Pharmaceutical Technology Chair of Prof. Dr. Gerhard Winter - Faculty for Chemistry and Pharmacy



Arsiccio A, Sarter T, Polidori I, Winter G, Pisano R, Shea JE.
Thermodynamic Modeling and Experimental Data Reveal That Sugars Stabilize Proteins According to an Excluded Volume Mechanism
J Am Chem Soc. 2023 Aug 2;145(30):16678-16690. doi: 10.1021/jacs.3c04293. Epub 2023 Jul 19.
PMID: 37466340

Ko SK, Björkengren G, Berner C, Winter G, Harris P, Peters GHJ.
Combining Molecular Dynamics Simulations and Biophysical Characterization to Investigate Protein-Specific Excipient Effects on Reteplase during Freeze Drying
Pharmaceutics. 2023 Jun 30;15(7):1854. doi: 10.3390/pharmaceutics15071854.
PMID: 37514040

Kulakova A, Augustijn D, El Bialy I, Gentiluomo L, Greco ML, Hervø-Hansen S, Indrakumar S, Mahapatra S, Martinez Morales M, Pohl C, Polimeni M, Roche A, Svilenov HL, Tosstorff A, Zalar M, Curtis R, Derrick JP, Frieß W, Golovanov AP, Lund M, Nørgaard A, Khan TA, Peters GHJ, Pluen A, Roessner D, Streicher WW, van der Walle CF, Warwicker J, Uddin S, Winter G, Bukrinski JT, Rinnan Å, Harris P.
Chemometrics in Protein Formulation: Stability Governed by Repulsion and Protein Unfolding
Mol Pharm. 2023 Jun 5;20(6):2951-2965. doi: 10.1021/acs.molpharmaceut.3c00013. Epub 2023 May 5.
PMID: 37146162

Härdter N, Geidobler R, Presser I, Winter G.
Accelerated Production of Biopharmaceuticals via Microwave-Assisted Freeze-Drying (MFD)
Pharmaceutics. 2023 Apr 27;15(5):1342. doi: 10.3390/pharmaceutics15051342.
PMID: 37242584

Rysin A, Lokerse WJM, Paal M, Habler K, Wedmann B, Hossann M, Winter G, Lindner LH.
Heat-Triggered Release of Dexamethasone from Thermosensitive Liposomes Using Prodrugs or Excipients
J Pharm Sci. 2023 Jul;112(7):1947-1956. doi: 10.1016/j.xphs.2023.04.001. Epub 2023 Apr 6.
PMID: 37030437

Zäh M, Brandenbusch C, Winter G, Sadowski G.
Predicting the amorphous-phase composition during lyophilization.
Int J Pharm. 2023 Mar 20;636:122836. doi: 10.1016/j.ijpharm.2023.122836. Online ahead of print.
PMID: 36940838

Groël S, Menzen T, Winter G.
Prediction of Unwanted Crystallization of Freeze-Dried Protein Formulations Using α-Relaxation Measurements.
Pharmaceutics. 2023 Feb 20;15(2):703. doi: 10.3390/pharmaceutics15020703.
PMID: 36840026

Thaller A, Schmauder L, Frieß W, Winter G, Menzen T, Hawe A, Richter K.
SV-AUC as a stability-indicating method for the characterization of mRNA-LNPs.
Eur J Pharm Biopharm. 2023 Jan;182:152-156. doi: 10.1016/j.ejpb.2022.11.014. Epub 2022 Nov 21.
PMID: 36410586

Svilenov HL, Kopp KT, Golovanov AP, Winter G, Zalar M.
Insights into the Stabilization of Interferon Alpha by Two Surfactants Revealed by STD-NMR Spectroscopy.
J Pharm Sci. 2023 Feb;112(2):404-410. doi: 10.1016/j.xphs.2022.10.013. Epub 2022 Oct 17.
PMID: 36257338


Klier J, Fuchs S, Winter G, Gehlen H.
Inhalative Nanoparticulate CpG Immunotherapy in Severe Equine Asthma: An Innovative Therapeutic Concept and Potential Animal Model for Human Asthma Treatment.
Animals (Basel). 2022 Aug 16;12(16):2087. doi: 10.3390/ani12162087.
PMID: 36009677

Krieg D, Winter G, Svilenov HL.
It is never too late for a cocktail - Development and analytical characterization of fixed-dose antibody combinations.
J Pharm Sci. 2022 Aug;111(8):2149-2157. doi: 10.1016/j.xphs.2022.05.014. Epub 2022 May 19.
PMID: 35598781

Ko SK, Berner C, Kulakova A, Schneider M, Antes I, Winter G, Harris P, Peters GHJ.
Investigation of the pH-dependent aggregation mechanisms of GCSF using low resolution protein characterization techniques and advanced molecular dynamics simulations.
Comput Struct Biotechnol J. 2022 Mar 17;20:1439-1455. doi: 10.1016/j.csbj.2022.03.012. eCollection 2022.
PMID: 35386098

Rieser R, Menzen T, Biel M, Michalakis S, Winter G.
Systematic Studies on Stabilization of AAV Vector Formulations by Lyophilization.
J Pharm Sci. 2022 Mar 5:S0022-3549(22)00110-1. doi: 10.1016/j.xphs.2022.03.004.
PMID: 35259349

Stelzl A, Grabarek A, Schneid S, Jiskoot W, Menzen T, Winter G.
Comparison of Submicron Particle Counting Methods with a Heat Stressed Monoclonal Antibody: Effect of Electrolytes and Implications on Sample Preparation.
J Pharm Sci. 2022 Jan 23:S0022-3549(22)00022-3. doi: 10.1016/j.xphs.2022.01.012.
PMID: 35081405


Opolka-Hoffmann E, Jordan G, Otteneder M, Kieferle R, Lechmann M, Winter G, Staack RF.
The impact of immunogenicity on therapeutic antibody pharmacokinetics: A preclinical evaluation of the effect of immune complex formation and antibody effector function on clearance.
MAbs. 2021 Jan-Dec;13(1):1995929. doi: 10.1080/19420862.2021.1995929.
PMID: 34763611

Groël, S; Menzen, T; Winter G.
Calorimetric Investigation of the Relaxation Phenomena in Amorphous Lyophilized Solid
Pharmaceutics 2021, 13, 1735                           

Härdter, N.; Menzen, T.; Winter, G.
Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach. Pharmaceutics 2021, 13, 1695.

Schargus M, Kopp KT, Helbig C, Frings A, Winter G.
Comparison of Syringes With Intravitreal Anti-VEGF Drugs: Particle Burden and Protein Aggregates in Brolucizumab, Aflibercept and Bevacizumab.
Transl Vis Sci Technol. 2021 Aug 2;10(9):21. doi: 10.1167/tvst.10.9.21.
PMID: 34406342

Stelzl A, Schneid S, Winter G.
Application of Tunable Resistive Pulse Sensing for the Quantification of Submicron Particles in Pharmaceutical Monoclonal Antibody Preparations.
J Pharm Sci. 2021 Nov;110(11):3541-3545. doi: 10.1016/j.xphs.2021.07.012. Epub 2021 Jul 22.
PMID: 34303672

Rysin A, Paal M, Lokerse WJM, Wedmann B, Hossann M, Vogeser M, Winter G, Lindner LH.
Evaluation of release and pharmacokinetics of hexadecylphosphocholine (miltefosine) in phosphatidyldiglycerol-based thermosensitive liposomes.
Biochim Biophys Acta Biomembr. 2021 Nov 1;1863(11):183698. doi: 10.1016/j.bbamem.2021.183698. Epub 2021 Jul 17.
PMID: 34283999

Gitter JH, Geidobler R, Halbinger W, Presser I, Winter G.
100% Control of Controlled Ice Nucleation Vials by Camera-Supported Optical Inspection in Freeze-Drying.
PDA J Pharm Sci Technol. 2021 Jun 15:pdajpst.2020.012575. doi: 10.5731/pdajpst.2020.012575. Online ahead of print.
PMID: 34131013

Ruth Rieser 1, Johanna Koch 1, Greta Faccioli 1, Klaus Richter 2, Tim Menzen 2,  Martin Biel 1, Gerhard Winter 1, * and Stylianos Michalakis 
Comparison of Different Liquid Chromatography-Based Purification Strategies for Adeno-Associated Virus Vectors

Rospiccio M, Arsiccio A, Winter G, Pisano R.
The Role of Cyclodextrins against Interface-Induced Denaturation in Pharmaceutical Formulations: A Molecular Dynamics Approach.
Mol Pharm. 2021 Jun 7;18(6):2322-2333. doi: 10.1021/acs.molpharmaceut.1c00135. Epub 2021 May 17.
PMID: 33999634

Rockinger U, Funk M, Winter G.
Current Approaches of Preservation of Cells During (freeze-) Drying.
J Pharm Sci. 2021 Aug;110(8):2873-2893. doi: 10.1016/j.xphs.2021.04.018. Epub 2021 Apr 30.
PMID: 33933434 Review.

Berner C, Menzen T, Winter G, Svilenov HL.
Combining Unfolding Reversibility Studies and Molecular Dynamics Simulations to Select Aggregation-Resistant Antibodies.
Mol Pharm. 2021 Jun 7;18(6):2242-2253. doi: 10.1021/acs.molpharmaceut.1c00017. Epub 2021 Apr 30.
PMID: 33928776

Rockinger U, Müller C, Bracher F, Funk M, Winter G.  
DMSO as new, counterintuitive excipient for freeze-drying human keratinocytes.
Eur J Pharm Sci. 2021 May 1;160:105746. doi: 10.1016/j.ejps.2021.105746. Epub 2021 Feb 6. 
PMID: 33561511


D. Krieg, C. Berner, G. Winter, H.L. Svilenov 
Biophysical Characterization of Binary Therapeutic Monoclonal Antibody Mixtures
Mol Pharm. 2020 Aug 3; 17(8):2971-2986. doi: 10.1021/acs.molpharmaceut.0c00370. Epub 2020 Jul 20. 
PMID: 32687367

H.L. Svilenov, T. Menzen, K. Richter, G. Winter
Modulated Scanning Fluorimetry Can Quickly Assess Thermal Protein Unfolding Reversibility in Microvolume Samples 
Mol Pharm. 2020 May 27; 17(7):2638-2647. doi: 10.1021/acs.molpharmaceut.0c00330. Epub 2020 May 27.
PMID: 32401526

H.L. Svilenov, G. Winter  
Formulations That Suppress Aggregation During Long-Term Storage of a Bispecific Antibody are Characterized by High Refoldability and Colloidal Stability
J Pharm Sci. 2020 Jun;109(6):2048-2058. doi: 10.1016/j.xphs.2020.03.011. Epub 2020 Mar 16.
PMID: 32194093

A. Tosstorff, G.H.J. Peters, G. Winter 
Study of the interaction between a novel, protein-stabilizing dipeptide and Interferon-alpha-2a by construction of a Markov state model from molecular dynamics simulations
Eur J Pharm Biopharm. 2020 Apr;149:105-112. doi: 10.1016/j.ejpb.2020.01.020. Epub 2020 Feb 5.
PMID: 32035237

A. Stulz, M. Breitsamer, G. Winter, H. Heerklotz
Primary and Secondary Binding of Exenatide to Liposomes
Biophys J. 2020 Jan 3. pii: S0006-3495(19)34428-5. doi: 10.1016/j.bpj.2019.12.028. Epub 2020 Jan 3.  


J.H. Gitter, R. Geidobler, I. Presser, G. Winter
Microwave-Assisted Freeze-Drying of Monoclonal Antibodies: Product Quality Aspects and Storage Stability
Pharmaceutics. 2019 Dec 12;11(12). pii: E674. doi: 10.3390/pharmaceutics11120674.

L. Gentiluomo, H.L. Svilenov, D. Augustijn, I. El Bialy, M.L. Greco, A. Kulakova, S. Indrakumar, S. Mahapatra, M.M.Morales, C. Pohl, A. Roche, A. Tosstorff, R. Curtis, J.P. Derrick, A. Noergaard, T.A. Khan, G.H.J. Peters, A. Pluen, Å. Rinnan, W.W. Streicher, C.F. van der Walle, S. Uddin, G. Winter, D. Roessner, P. Harris, W. Friess 
Advancing therapeutic protein discovery and development through comprehensive computational and biophysical characterization
Mol Pharm. 2019 Dec 2. doi: 10.1021/acs.molpharmaceut.9b00852. Epub 2020 Jan 7. 

A. Tosstorff, T. Menzen, G. Winter 
Exploring Chemical Space for new Substances to stabilize a therapeutic Monoclonal Antibody
J Pharm Sci. 2019 Nov 4. pii: S0022-3549(19)30729-4. doi: 10.1016/j.xphs.2019.10.057. Epub 2019 Nov 5.

H. Svilenov, A. Kulakova, M. Zalar, A.P. Golovanov, P. Harris, G. Winter 
Orthogonal techniques to study the effect of pH, sucrose and arginine salts on monoclonal antibody physical stability and aggregation during long-term storage
J Pharm Sci. 2019 Nov 2. pii: S0022-3549(19)30737-3. doi: 10.1016/j.xphs.2019.10.065. Epub 2019 Nov 2.

D. Krieg, H. Svilenov, J.H. Gitter, G. Winter 
Overcoming challenges in co-formulation of proteins with contradicting stability profiles - EPO plus G-CSF
Eur J Pharm Sci. 2019 Oct 23;141:105073. doi: 10.1016/j.ejps.2019.105073. Epub 2019 Oct 23.  

R. Rieser,M. Penaud-Budloo, M. Bouzelha, A. Rossi, T. Menzen, M. Biel, H. Büning, E. Ayuso, G. Winter, S. Michalakis 
Intrinsic Differential Scanning Fluorimetry for Fast and Easy Identification of AAV Serotypes
J Pharm Sci. 2019 Oct 19. pii: S0022-3549(19)30668-9. doi: 10.1016/j.xphs.2019.10.031. Epub 2019 Oct 19. 

A. Tosstorff, H. Svilenov, G.H.J. Peters, P. Harris P, G. Winte
Structure-based Discovery of a new Protein-Aggregation Breaking Excipient
Eur J Pharm Biopharm. 2019 Nov;144:207-216. doi: 10.1016/j.ejpb.2019.09.010. Epub 2019 Sep 12

R. Mathaes, M.C. Manning, G. Winter, J. Engert, G.A. Wilson 
Shape Characterization of Subvisible Particles Using Dynamic Imaging Analysis
J Pharm Sci. 2019 Aug 30. pii: S0022-3549(19)30556-8. doi: 10.1016/j.xphs.2019.08.023. Epub 2019 Aug 30. 

B.M. Haryadi, D. Hafner, I. Amin, R. Schubel, R. Jordan, G. Winter, J. Engert 
Nonsherical Nanoparticle Shape Stability is Affected by Complex Manufacturing Aspects: Its Implications for Drug Delivery and Targeting
Adv Healthc Mater. 2019 Aug 13:e1900352. doi: 10.1002/adhm.201900352. Epub 2019 Aug 13.

L. Rodrigues, F. Schneider, X. Zhang,  E .Larsson, L.W.K. Moodie, H. Dietz, C.M. Papadakis, G. Winter, R. Lundmark, M. Hubert
Cellular uptake of self-assembled phytantriol-based hexosomes is independent of major endocyctic machineries
J Colloid Interface Sci. 2019 Jun 19;553:820-833. doi: 10.1016/j.jcis.2019.06.045. Epub 2019 Jun 19. 

E. Hoffmann, G. Jordan, M. Lauer, P. Ringler, E.A. Kusznir, A.C. Rufer, S. Huber, A. Jochner, G. Winter, R.F. Staack
Generation, Characterization and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicted In Vivo Studies
Pharm Res. 2019 Jun 28;36(9):129. doi: 10.1007/s11095-019-2661-0

M. Breitsamer, A. Stulz,  H.H. Heerklotz, G. Winter
Do interactions between Protein and Phospholipids influence the release behavior from lipid-based exenatide depot systems?
Eur J Pharm Biopharm . 2019 Sep;142:61-69. doi: 10.1016/j.ejpb.2019.06.007. Epub 2019 Jun 10. 
PMID: 31195130

J. Klier, C. Bartl, S. Geuder, K.J. Geh, S. Reese, L.S. Goehring, G. Winter, H. Gehlen
Immunomodulatory asthma therapy in the equine animal model: A dose-response study and evaluation of a long-term effect
Immun Inflamm Dis. 2019 May 29. doi: 10.1002/iid3.252. Epub 2019 May 29. 
PMID: 31141308

L. Gentiluomo, D. Roessner, D. Augustijn, H. Svilenov, A. Kulakova, S.Mahapatra, G. Winter, W. Streicher, Å. Rinnan, G.H.J Peters, P. Harris P, W. Frieß
Application of interpretable artificial neural networks to early monoclonal antibodies development
Eur J Pharm Biopharm. 2019 Aug;141:81-89. doi: 10.1016/j.ejpb.2019.05.017. Epub 2019 May 18.
PMID: 31112768

H. Svilenov, G. Winter 
Rapid sample-saving biophysical characterisation and long-term storage stability of liquid interferon alpha2a formulations: Is there a correlation?
Int J Pharm. 2019 May 1;562:42-50. doi: 10.1016/j.ijpharm.2019.03.025. Epub 2019 Mar 14.
PMID: 30878589

Ch. Müller, A.L. Wagner, U. Rockinger, G. Winter, F. Bracher
Development of a convenient method for the determination of dimethyl sulfoxide in lyophilised pharmaceuticals by static headspace gas chromatography-mass spectrometry
Anal. Methods 2019 March 19;2119-2122; doi:10.1039/C8AY02574F

H. Svilenov, G. Winter 
The ReFOLD assay for protein formulation studies and prediction of protein aggregation during long-term storage
Eur J Pharm Biopharm. 2019 Feb 25. pii: S0939-6411(18)31536-4. doi: 10.1016/j.ejpb.2019.02.018. Epub 2019 Feb 15.
PMID: 30818009

T. Kraus, A. Lubitz, U. Schließer, C.Giese, J. Reuschel, R. Brecht, J. Engert J, G.Winter
Evaluation of a 3D human artificial lymph node as test model for the assessment of immunogenicity of protein aggregates
J Pharm Sci. 2019 Feb 21. pii: S0022-3549(19)30096-6. doi: 10.1016/j.xphs.2019.02.011. Epub 2019 Feb 21. 
PMID: 30797781

T. Kraus, G. Winter, J. Engert 
Test models for the evaluation of immunogenicity of protein aggregates
Int J Pharm. 2019 Jan 18;559:192-200. doi: 10.1016/j.ijpharm.2019.01.015. Epub 2019 Jan 18. Review.
PMID: 30665000


I. Vollrath, W. Friess, A. Freitag, A. Hawe,G. Winter 
Comparison of ice fog methods and monitoring of controlled nucleation success after freeze-drying
Int J Pharm. 2018 Dec 28;558:18-28. doi: 10.1016/j.ijpharm.2018.12.056. Epub 2018 Dec 28.
PMID: 30597272

M. Breitsamer, G. Winter 
Vesicular phospholipid gels as drug delivery systems for small molecular weight drugs, peptides and proteins: State of the art review
Int J Pharm. 2018 Dec 18;557:1-8. doi: 10.1016/j.ijpharm.2018.12.030. Epub 2018 Dec 18.
PMID: 30572079

N. Scherer, K. Marcseková, T. Posset, G. Winter 
New Studies on Leachables in commercial scale Potein Drug Filling Lines using Stir Bar Sorptive Extraction coupled with TD-GC-MS and UPLC/QTOF-MS/MS analytics
Int J Pharm. 2018 Nov 27. pii: S0378-5173(18)30851-2. doi: 10.1016/j.ijpharm.2018.11.033. Epub 2018 Nov 27.
PMID: 30500460

M.L. Pöhlmann, A.S. Häusl, D. Harbich, G. Blasevich, C. Engelhardt, X. Feng, M. Breitsamer, F. Hausch, G. Winter, M.V. Schmidt
Pharmacological modulation of the psychiatric risk factor FKBP51 alters efficiency of common antidepressant drugs.
Front Behav Neurosci. 2018 Nov 12;12:262. doi: 10.3389/fnbeh.2018.00262. eCollection 2018
PMID: 30483074

B.P. Werner, C. Schöneich, G. Winter
Silicone oil free polymer syringes for the storage of therapeutic proteins
J Pharm Sci. 2018 Nov 1. pii: S0022-3549(18)30681-6. doi: 10.1016/j.xphs.2018.10.049. Epub 2018 Nov 2.
PMID: 30391415

H. Svilenov, L. Gentiluomo, W. Friess, D. Roessner, G. Winter
A New Approach to Study the Physical Stability of Mnoclonal Antibody Formulations -  Dilution from a Denaturant
J Pharm Sci. 2018 Aug 16. pii: S0022-3549(18)30503-3. doi: 10.1016/j.xphs.2018.08.004. Epub 2018 Aug 16.
PMID: 30121313

B.P. Werner, G. Winter
Expanding bedside filtration - a powerful tool to protect patients from protein aggregates
J Pharm Sci. 2018 Jul 27. pii: S0022-3549(18)30457-X. doi: 10.1016/j.xphs.2018.07.022. Epub 2018 Jul 27.
PMID: 30059660

J.H. Gitter, R. Geidobler, I. Presser, G. Winter
A Comparison of Controlled Ice Nucleation Techniques for Freeze-Drying of Therapeutic Antibody
J Pharm Sci. 2018 Jul 25. pii: S0022-3549(18)30454-4. doi: 10.1016/j.xphs.2018.07.019. Epub 2018 Jul 25
PMID: 30055225

Y. Yordanova, W. Vanderlinden, R. Stoll, D. Rüdiger, A. Tosstorff, W. Zaremba, G. Winter, S. Zahler, W. Friess
‎Zn+2 -triggered self-assembly of Gonadorelin [6-D-Phe] to produce nanostructures and fibrils
Sci Rep. 2018 Jul 26;8(1):11280. doi: 10.1038/s41598-018-29529-w.
PMID: 30050082

L. Rodrigues, K.N.Raftopoulos, S.T. Schmidt, F. Schneider, H. Dietz, T. Rades, H. Franzyk, A.E.Pedersen, C.M.Papadakis, D. Christensen, G. Winter, C. Foged, M. Hubert
Immune responses induced by nano-self-assembled lipid adjuvants based on monomycoloyl glycerol analogue after vaccination with the Chlamydia trachomatis major outer membran
J Control Release. 2018 Jun 28. pii: S0168-3659(18)30376-6. doi:10.1016/j.jconrel.2018.06.028. Epub 2018 Jun 28.
PMID: 29964134 

X. Zhang, P. Chytil, T. Etrych, W. Liu, L. Rodrigues, G. Winter, S.K.Filippov, C.M. Papadakis
Binding of HSA to Macromolecular pHPMA Based Nanoparticles for Drug Delivery: An Investigation Using Fluorescence Methods
Langmuir. 2018 Jun 27: doi: 10.1021/acs.langmuir.8b01015. Epub 2018 Jun 27.
PMID: 29949376 

M. Vollrath,J. Engert J, G. Winter 
New insights into process understanding of solid lipid extrusion (SLE) of extruded lipid implants for sustained  protein delivery
Eur J Pharm Biopharm. 2018 Jun 15. pii: S0939-6411(17)31026-3. doi: 10.1016/j.ejpb.2018.06.016. 
Epub 2018 Jun 18.
PMID: 29913270

J.H. Gitter, R. Geidobler, I. Presser, G. Winter
Significant Drying Time Reduction using Microwave-Assisted Freeze-Drying for a Monoclonal Antibody
J Pharm Sci..2018.05.0232018 Jun 8. pii: S0022-3549(18)30329-0. doi: 10.1016/j.xphs.2018.05.023. 
Epub 2018 Jun 8.
PMID: 29890173

I.Vollrath, W. Friess, A. Freitag, A. Hawe, G. Winter 
Does controlled nucleation impact the properties and stability of lyophilized monoclonal antibody formulations?
Eur J Pharm Biopharm. 2018 May 22. pii: S0939-6411(18)30223-6. doi: 10.1016/j.ejpb.2018.05.025. Epub 2018 May 22.
PMID: 29800618

K.J.Geh, M. Hubert, G.Winter 
Progress in formulation development and sterilisation of freeze-dried oligodeoxynucleotide-loaded gelatine nanoparticles
Eur J Pharm Biopharm. 2018 May 16. pii: S0939-6411(18)30138-3. doi: 10.1016/j.ejpb.2018.05.016. Epub 2018 May 16.
PMID: 29777773

M. Lucke, I. Mottas, T.  Herbst, C. Hotz, L.Römer, M. Schierling, H.M. Herold, U. Slotta, T. Spinetti, T. Scheibel, G. Winter, C. Bourquin, J. Engert 
Engineered hybrid spider silk particles as delivery system for peptide vaccines
Biomaterials. 2018 Apr 21;172:105-115. doi: 10.1016/j.biomaterials.2018.04.008. Epub 2018 Apr 21.
PMID: 29723755

J. Engert, C. Anamur, L. Engelke, C. Fellner, P. Lell, S. Henke, J. Stadler, S. Zöls, M. Ritzmann, G. Winter
A pilot study using a novel pyrotechnically driven prototype applicator for epidermal powder immunization in piglets
Int J Pharm. 2018 Jul 10;545(1-2):215-228. doi: 10.1016/j.ijpharm.2018.04.039. Epub 2018 Apr 20.
PMID: 29684561

L. Engelke, G. Winter, J. Engert
Application of water-soluble polyvinyl alcohol-based film patches on laser microporated skin facilitates intradermal macromolecule and nanoparticle delivery
Eur J Pharm Biopharm. 2018 Jul; 128:119-130. doi: 10.1016/j.ejpb.2018.04.008. Epub 2018 Apr 13.
PMID: 29660407

M. Maiarù, O.B. Morgan, T. Mao, M. Breitsamer, H. Bamber, M. Pöhlmann, M.V. Schmidt, G. Winter, F. Hausch, S.M: Géranton
The Stress Regulator Fkbp51: A Novel and Promising Druggable Target for the Treatment of Persistent Pain States Across Sexes
Pain. 2018 Jul;159(7):1224-1234. doi: 10.1097/j.pain.0000000000001204.
PMID: 29533388

N. Scherer, K. Marcsekova, T. Posset, G. Winter
Evaluation of stir-bar sorptive extraction coupled with thermal desorption GC-MS for thr detection of leachables from polymer single use systems to drugs
J Pharm Biomed Anal. 2018 Apr 15;152:66-73. doi: 10.1016/j.jpba.2018.01.045. Epub 2018 Feb 3.
PMID: 29414020

H. Svilenov, U. Markoja, G. Winter
Isothermal Chemical Denaturation as a Complimentary Tool to Overcome Limitations of Thermal Differential Scanning Fluorimetry in Predicting Physical Stability of Protein Formulations
Eur J Pharm Biopharm. 2018 Apr;125:106-113. doi: 10.1016/j.ejpb.2018.01.004. Epub 2018 Jan 9.
PMID: 29329817


G. Balsevich, A.S. Häusl, C.W. Meyer, S. Karamihalev, X. Feng, M.L. Pöhlmann, C. Dournes, A. Uribe-Marino, S. Santarelli, C. Labermaier, K. Hafner,T. Mao, M. Breitsamer, M. Theodoropoulou, C. Namendorfer, M. Uhr, M. Paez-Pereda, G. Winter, F. Hausch, A. Chen, M.H. Tschöp, T. Rein, N.C. Gassen, M. V. Schmidt
Stress-responsive FKBP51 regulates AKT2-AS160 signaling and metabolic function
Nature Communications 2017 Nov 23;8(1):1725.doi: 10.1038/s41467-017-01783-y.
PMID: 29170369 

B. Werner, G. Winter
Addressing Protein Aggregation
The Medicine Maker 2017 Nov; 38-40

J. Klier, S. Geis, J. Steuer, K. Geh, S. Reese, S. Fuchs, R.S. Mueller, G. Winter, H. Gehlen
A comparison of nanoparticullate CpG immunotherapy with and without allergens in spontaneously equine asthma-affected horses, an animal model
Immun Inflamm Dis. 2018 Mar;6(1):81-96. doi: 10.1002/iid3.198. Epub 2017 Nov 1.
PMID: 29094511

E. Agostini, G. Winter, J. Engert
Scale-up of water-based spider silk film casting using a film applicator
Int J Pharm. 2017 Oct 30; 532(1): 13-20. Epub 2017 Aug 24.
PMID: 28844898

M. Schargus, B.P. Werner, G. Geerling, G. Winter
CONTAMINATION OF ANTI-VEGF DRUGS FOR INTRAVITREAL INJECTION: How Do Repackaging and Newly Developed Syringes Affect the Amount of Silicone Oil Droplets and Protein Aggregates
Retina. 2017 Aug 21. doi: 10.1097/IAE.0000000000000809. 
PMID: 28841584

J.J. Mittag, B. Kneidl, T. Preiß, M. Hossann, G. Winter, S. Wuttke, H. Engelke, J.O. Rädler
Impact of plasma protein binding on cargo release by thermosensitive liposomes probed by fluorescence correlation spectroscopy
Eur J Pharm Biopharm. 2017 Oct; 119: 215-23. Epub 2017 Jun 23.
PMID: 28648864

R. Wanner, D. Breitsprecher, S. Duhr, P. Baaske, G. Winter
Thermo-Optical Protein Characterization for Straightforward Preformulation Development
J Pharm Sci. 2017 Oct; 106(10): 2955-58. Epub 2017 Jun 15.
PMID: 28624419

I. Wagner, K. Geh, M. Hubert, G. Winter, K. Weber, J. Classen, C. Klinger, R.S. Mueller
Preliminary evaluation of cytosine-phosphate-guanine oligodeoxynucleotides bound to gelatine nanoparticles as immunotherapy for canine atopic dermatitis
Vet Rec. 2017 Jul 29;181(5):118. doi: 10.1136/vr.104230. Epub 2017 May 19

M. Vollrath, J. Engert, G. Winter
Long-term release and stability of pharmaceutical proteins delivered from solid lipid implants
Eur J Pharm Biopharm. 2017 Aug; 117:244-55. Epub 2017 Apr 22.
PMID: 28442372

S.M. Patel, S.L. Nail, M.J. Pikal, R. Geidobler, G. Winter, A. Hawe, J. Davagnino, S. Rambhatla Gupta
Lyophilized Drug Product Cake Appearance: What is Acceptable?
J Pharm Sci. 2017 Jul; 106(7): 1706-21. Epub 2017 Mar 22.
PMID: 28341598

A. Martos, W. Koch, W. Jiskoot, K. Wuchner, G. Winter, W. Friess, A. Hawe
Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations
J Pharm Sci. 2017 Jul; 106(7): 1722-35. doi: 10.1016/j.xphs.2017.03.001. Epub 2017 Mar 14. Review.
PMID: 28302541

M. Utzinger, A. Jarzebinska, N. Haag, M. Schweizer, G. Winter, C. Dohmen, C. Rudolph, C. Plank
cmRNA/lipoplex encapsulation in PLGA microsheres enables transfection via calcium phosphate cement (CPC)/PLGA composites
J Control Release. 2017 Mar 10; 249:143-49. Epub 2017 Feb 2.
PMID: 28161466

M.P. Even, S. Bobbala, B. Gibson, S. Hook, G. Winter, J. Engert
Twin-screw extruded lipid implants containing TRP2 peptide for tumour therapy
Eur J Pharm Biopharm. 2017 May; 114:79-87. Epub 2017 Jan 16.
PMID: 28104440

I. Vollrath, V. Pauli, W. Friess, A. Freitag, A. Hawe, G. Winter
Evaluation of Heat Flux Measurement as a New Process Analytical Technology Monitoring Tool in Freeze Drying
J Pharm Sci. 2017 May; 106(5):1249-57. Epub 2017 Jan 4.
PMID: 28063826

M. Breitsamer, G. Winter
Needle-Free Injection of Vesicular Phospholipid Gels- A Novel Approach to Overcome an Administration Hurdle for Semisolid Depot Systems
J Pharm Sci. 2017 Apr; 106(4): 968-72. Epub 2016 Dec 29.
PMID: 28041969

M.L. Poehlmann, J. Hartmann, D. Harbich, B. Schmid, A.S. Häusl, N. Dedic, X. Feng, F. Hausch, M. Breitsamer, G. Winter, J. Deussing, M.V. Schmidt
Unraveling the functional contribution of FKBP-51 in monoaminergic brain areas to stress vulnerability in mice
Eur Neuropsychopharmacol. 2017 Mar; 27(1):39.  doi: 10.1016/S0924-977X(17)30109-8.


L. Rodrigues, K. Kyriakos, F. Schneider, H. Dietz, G. Winter, C.M. Papadakis, M. Hubert
Characterization of Lipid-Based Hexosomes as Versatile Vaccine Carriers
Mol Pharm. 2016 Nov 7; 13(11):3945-3954. Epub 2016 Sep 27.
PMID: 27607892

K.J. Geh, M. Hubert, G. Winter
Optimisation of one-step desolvation and scale-up of gelatine nanoparticle production
J Microencapsul. 2016 Nov; 33(7):595-604. Epub 2016 Sep 7.
PMID: 27556342 

J. Klier, C. Zimmermann, L.S. Goehring, G. Winter, H. Gehlen
Nanoparticulate CpG immunotherapy in RAO-affected horses: dose effect, long term benefits and comparison with beclomethasone inhalation
Equine Vet J 2016 Sep 1; doi: 10.1111/evj.03_12612

C. Hildebrandt, R. Mathaes, R. Saedler, G. Winter
Origin of aggregate formation in antibody crystal suspensions containing PEG
J PharmSci. 2016 Mar; 105(3):1059-65. Epub 2016 Feb 2.
PMID: 26886344


J. Kibat, T. Schirrmann, M.J. Knape, S. Helmsing, D. Meier, M. Hust, C. Schröder, D. Bertinetti, G. Winter, K. Pardes, M. Funk, A. Lages, N. Giese, F.W. Herberg, S. Dübel, J.D. Hoheisel
Utilisation of antibody microarrays for the selection of specific and informative antibodies from recombinant library binders of unknown quality
N Biotechnol. 2016 Sep 25;33(5Pt A):574-81. Epub 2015 Dec 17.
PMID: 26709003

B. Werner, G. Winter
Particle contamination of parenteralia and in-line filtration of proteinaceous drugs
Int J Pharm. 2015 Dec 30; 496(2): 250-67. Epub 2015 Nov 7.
PMID: 26556624

R. Liebner, S. Bergmann, T. Hey, G. Winter, A. Besheer
Freeze-drying of HESylated IFNα-2b:Effect of HESylation on storage stability in comparison to PEGylation
Int J Pharm.2015 Nov 10;495(1):608-611. Epub 2015 Sep 24.
PMID: 26387618

J. Klier, S. Geis, J. Steuer, S. Reese, S. Fuchs, R.S. Mueller, G. Winter, H. Gehlen
Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015
Equine Vet J. 2015 Sep; 47 Suppl 48:26. doi: 10.1111/evj.12486_58. 
PMID: 26375616

M.P. Even, S. Bobbala, K.L. Kooi, S. Hook, G. Winter, J. Engert
Impact of implant composition of twin-screw extruded lipid implants on the release behaviour
Int J Pharm. 2015 Sep 30; 493(1-2):102-10. Epub 2015 Jul 15.
PMID: 26188320

R. Mathaes, G. Winter, T.J. Siahaan. A. Besheer, J. Engert
Influence of particle size, an elongated particle geometry, and adjuvants on dendritic cell activation
Eur J Pharm Biopharm. 2015 Aug; 94:542-9.Epub 2015 Jun 26.
PMID: 26118563 

E. Agostini, G. Winter, J. Engert 
Water-based preparation of spider silk films as drug delivery matrices
J Control Release. 2015 Sep 10;213:134-141. Epub 2015 Jun 20.
PMID: 26100366

L. Engelke, G. Winter, S. Hook, J. Engert
Recent insights into cutaneous immunization: How to vaccinate via the skin
Vaccine. 2015 MaSep 8; 33(37): 4663-74. doi: 10.1016/j.vaccine.2015.05.012. Epub 2015 May 23.
PMID: 26006087

A. Schoch, H. Kettenberger, O. Mundigl, G. Winter, J. Engert , J. Heinrich, T. Emrich
Charge-mediated influence of the antibody variable domain on FcRn-dependent pharmacokinetics
Proc Natl Acad Sci U S A. 2015 May 12; 112(19):5997-6002. Epub 2015 Apr 27.
PMID: 25918417

S. Buchmann, G.H. Sandmann, L. Walz, T. Reichel, K. Beitzel, G. Wexel, W. Tian, A. Battmann, S. Vogt, G. Winter, A.B. Imhoff
Growth factor release by vesicular phospholipid gels: in-vitro results and application for rotator cuff repair in a rat model
BMC Musculoskelet Disord. 2015 Apr 10;16(1):82.
PMID: 25888096

C. Hildebrandt, L. Joos, R. Saedler, G. Winter
The "New Polyethylene Glycol Dilemma": polyethylene glycol impurities and their paradox role in mAb crystallization
J Pharm Sci. 2015 Jun; 104(6): 1938-1945. Epub 2015 Mar 21.
PMID: 25808186

A. Schmitt, P. Rödel, C. Anamur, C. Seeliger, A.B. Imhoff, E. Herbst, S. Vogt, M. van Griensven, G. Winter, J. Engert
Calcium alginate gels as stem cell matrix - making paracrine stem cell activity available for enhanced healing after surgery
PLoS One. 2015 Mar 20; 10(3):e0118937. eCollection 2015.
PMID: 25793885 

M. Shomali, S. Tanriverdi, A.J. Freitag, J. Engert, G. Winter, M. Siedler, Z. Kaymakcalan, J.F. Carpenter, T.W. Randolph
Dose levels in particulate-containing formulations impact anti-drug antibody responses to murine monoclonal antibody in mice
J Pharm Sci. 2015 May; 104(5):1610-21. Epub 2015 Mar 3.
PMID: 25737325 

S. Horiuchi, G. Winter
CMC determination of nonionic surfactants in protein formulations using ultrasonic resonance technology
Eur J Pharm Biopharm. 2015 May; 104(5): 1610-21. Epub 2015 Feb 12.
PMID: 25684280 

C. Anamur, G. Winter, J. Engert
Stability of collapse lyophilized influenza vaccine formulations
Int J Pharm 2015 Apr 10; 483(1-2): 131-141. Epub 2015 Feb 7.
PMID: 25660049  

J. Klier, B. Lehmann, S. Fuchs, S. Reese, A. Hirschmann, C. Coester, G. Winter, H. Gehlen
Nanoparticulate CpG immunotherapy in RAO-affected horses: phase I and IIa study
J Vet Intern Med. 2015 Jan:29(1):286-293.
PMID: 2561952

M. Lucke, G. Winter, J. Engert
The effect of steam sterilization on recombinant spider silk particles
Int J Pharm.2015 Mar 15; 481(1-2): 125-31.  Epub 2015 Jan 14.
PMID: 25596418 

D.B. Volkin, S. Hershenson, R.J. Ho, S. Uchiyama, G. Winter, J.F. Carpenter
Two decades of publishing excellence in Pharmaceutical Biotechnology
J Pharm Sci. 2015 Feb; 104(2):290-300.  Epub 2014 Dec 1.
PMID: 25448882 

R. Liebner, M. Meyer, T. Hey, G. Winter, A. Besheer
Head to head comparison of the formulation and stability of concentrated solutions of HESylated versus PEGylated Anakinra
J Pharm Sci. 2015 Feb; 104(2):515-526. Epub 2014 Dec 1.
PMID: 25445200 


R. Mathaes, G. Winter, A. Besheer, J. Engert
Non-spherical micro-and nanoparticles: fabrication, characterization and drug delivery applications
Expert Opin Drug Deliv. 2015 Mar; 12(3): 481-92. Epub 2014 Oct 18. Review.
PMID: 25327886 

S.P. Hertel, G. Winter, W. Friess
Protein stability in pulmonary drug delivery via nebulization
Adv Drug Deliv Rev. 2015 Oct 1. 93: 79-94. Epub 2014 Oct 12. Review.
PMID: 25312674 

C.G. Alexander, R. Wanner, C.M. Johnson, D. Breitsprecher, G. Winter, S. Duhr, P. Baaske, N. Ferguson
Novel microscale approaches for easy, rapid determination of protein stability in academic and commercial settings
Biochim Biophys Acta. 2014 Dec; 1844(12):2241-2250. Epub 2014 Sep 28.
PMID: 25262836 

N. Barapatre, P. Symvoulidis, W. Möller, F. Prade, N.C. Deliolanis, S. Hertel, G. Winter, A.O. Yildirim, T. Stoeger, O. Eickelberg, V. Ntziachristos, O. Schmid
Quantitative detection of drug dose and spatial distribution in the lung revealed by cryoslicing imaging
J Pharm Biomed Anal. 2015 Jan; 102:129-136. Epub 2014 Sept 8
PMID: 25262414 

B. Kneidl, M. Peller, G. Winter, L.H. Lindner, M. Hossann
Thermosensitive liposomal drug delivery systems: state of  the art review
Int J Nanomedicine. 2014 Sep 16; 9:4387-4398. eCollection 2014. 
PMID: 25258529 

A.J. Freitag, M. Shomali, S. Michalakis, M. Biel, M. Siedler, Z. Kaymakcalan, J.F. Carpenter, T.W. Randolph, G. Winter, J. Engert
Investigation of the immunogenicity of different types of aggregates of a murine monoclonal antibody in mice
Pharm. Res. 2015 Feb; 32("):430-44. Epub 2014 Aug 15.
PMID: 25123991 

Y. Deng, R. Mathaes, G. Winter, J. Engert
Encapsulation of antigen-loaded silica nanoparticles into microparticles for intradermal powder injection
Eur J Pharm Sci. 2014 Oct 15; 63:154-166. Epub 2014 Jul 17.
PMID: 25042055   

M.Noga, D: Edinger, E. Wagner, G. Winter, A. Besheer
Characterization and compatibility of hydroxyethyl starch-polyethylenimine copolymers for DNA delivery
J Biomater Sci Polym Ed. 2014 Jun;25(9):855-871. Epub 2014 May 2.
PMID: 24787557 

M. Noga, D. Edinger, E. Wagner, G. Winter, A. Besheer
Stability and activity of hydroxyethyl starch- coated polyplexes in frozen solutions or lyophilizates
Int J Pharm. 2014 Jul 20; 469(1):50-8. Epub 2014 Apr 13.
PMID: 24727140 

S. Hertel, T.Pohl, W. Friess, G. Winter
Prediction of protein degradation during vibrating mesh nebulization via a high throughput screening method
Eur J Pharm Biopharm. 2014 Jul; 87(2):386-94. Epub 2014 Apr 4.
PMID: 24709473 

R. Liebner, R. Mathaes, M. Meyer, T. Hey, G. Winter, A. Besheer
Protein HESylation for half-life extension: Synthesis, characterization and pharmacokinetics of HESylated anakinra
Eur J Pharm Biopharm, 2014 Jul; 87(2):378-85. Epub 2014 Mar 27. 
PMID: 24681396 

S. Hertel, T. Pohl, W. Friess, G. Winter
That´s cool! – Nebulization of thermolabile proteins with a cooled vibrating mesh nebulizer
Eur J Pharm Biopharm. 2014 Jul; 87(2):357-65. doi: 10.1016/j.ejpb.2014.03.001. Epub 2014 Mar 15.
PMID: 24662437 

M.P. Even, K. Young, G. Winter, S. Hook, J. Engert
In vivo investigation of twin-screw extruded lipid implants for vaccine delivery
Eur J Pharm Biopharm. 2014 Jul; 87(2):338-46. Epub 2014 Mar 4.
PMID: 24607791 

R. Mathaes, G. Winter, A. Besheer, J. Engert
Influence of particle geometry and PEGylation on phagocytosis of particulate carriers
Int J Pharm. 2014 Apr 25; 465(1-2):159-64. Epub 2014 Feb 21.
PMID: 24560647 

A. Schoch,  I.S. Thorey, J. Engert, G. Winter, T. Emrich
Comparison of the lateral tail vein and the retro-orbital venous sinous routes of antibody administration in pharmacokinetic studies
Lab Anim(NY) 2014 Mar; 43(3):95-9. doi: 10.1038/laban.481.
PMID: 24552915 

N.R. Maddux, V. Iyer, W. Cheng,  A.M. Youssef,  S.B. Joshi, D.B. Volkin, J.P. Ralston, G. Winter, C.R. Middaugh
High throughput prediction of the long-term stability of pharmaceutical macromolecules from short-term multi- instrument spectroscopic data
J Pharm Sci. 2014 Mar; 103(3): 828-39. Epub 2014 Jan 13. 
PMID: 24421157 


M. Shomali, A. Freitag, J. Engert, M. Siedler, Z. Kaymakcalan, G. Winter, J.F. Carpenter, T.W. Randolph
Antibody responses in mice to particles formed from adsorption of a murine monoclonal antibody onto glass microparticles
J Pharm Sci. 103(1) (2014) 78-89. Epub 2013 Nov 13.
PMID: 24227137 

H. Nishi, R. Mathäs, R. Fürst, G. Winter
Label-free flow cytometry analysis of subvisible aggregates in liquid IgG1 antibody formulations
J Pharm Sci 103(1) (2014) 90-99. Epub 2013 Nov 11.
PMID: 24218205 

E. Härtl, G. Winter, A.Besheer
Influence of hydroxypropyl-Beta-cyclodextrin on the stability of dilute and highly concentrated immunoglobulin g formulations
J Pharm Sci 102 (11) (2013) 4121-4131. Epub 2013 Sep 19.
PMID: 24105716 

 S. Zölls, D. Weinbuch, M. Wiggenhorn, G. Winter, W. Friess, W. Jiskoot, A. Hawe
Flow imaging microscopy for protein particle analysis- a comparative evaluation of four different analytical instruments
AAPS J. 15 (4) (2013), 1200-1211. Epub 2013 Aug 31.
PMID: 23996547 

 R. Geidobler, I. Konrad, G. Winter
Can controlled ice nucleation improve freeze-drying of highly-concentrated protein formulations ?
J Pharm Sci 102 (11) (2013), 3915-3919. Epub 2013 Aug 20.
PMID: 23963664  

 R. Mathaes, C. Hildebrandt, G. Winter, J. Engert, A. Besheer
Quality control of protein crystal suspensions using microflow imaging and flow cytometry
J Pharm Sci 102 (10) (2013), 3860-3866. Epub 2013 Jul 30.
PMID: 23900796 

A. R. Prélaud, S. Fuchs, K. Weber, G. Winter, C. Coester, R. S. Müller
In vitro effects of CpG oligodeoxynucleotides delivered by gelatin nanoparticles on canine peripheral blood mononuclear cells of atopic and healthy dogs – a pilot study
Vet Dermatol  24 (5) (2013), 494-e117.
PMID: 23826658 

W. Friess, G. Winter
Meeting the challenges in freeze-drying of pharmaceuticals and biological
Eur J Pharm Biopharm 2013 Jun 29.
PMID: 23820293

J. C.  Kasper, G. Winter, W. Friess
Recent advances and further challenges in lyophilization
Eur J Pharm Biopharm 2013 Jun 7. Epub 2013 Jun 7. 
PMID: 2375160

K. Schersch, O. Betz, P. Garidel, S. Muehlau, S. Bassarab, G. Winter
Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins III: Collapse during storage at elevated temperatures
Eur J Pharm Biopharm 2013 May 31. Epub 2013 May 31. 
PMID: 23727369

R. Mathaes, G. Winter, J. Engert, A. Besheer
Application of different analytical methods for the characterization of non-spherical micro- and nanoparticles
Int J Pharm 2013 May 29. Epub 2013 May 29. 

E. Härtl, N. Dixit, A. Besheer, D. Kalonia, G. Winter
Weak antibody-cyclodextrin interactions determined by quartz crystal microbalance and dynamic/static light scattering
Eur J Pharm Biopharm 2013 May 17. Epub 2013 May 17. 
PMID: 23685354

R. Geidobler, G. Winter
Controlled ice nucleation in the field of freeze-drying: Fundamentals and technology review
Eur J Pharm Biopharm 2013 May 2. Epub 2013 May 2. 
PMID: 23643793

D. Weinbuch, S. Zölls, M. Wiggenhorn, W. Friess, G. Winter, W. Jiskoot, A. Hawe
Micro-flow imaging and resonant mass measurement (Archimedes) – complementary methods to quantitatively differentiate protein particles and silicone oil droplets
J Pharm Sci 102 (7) (2013), 2152-2165. Epub 2013 Apr 26.
PMID: 23625851

S. Zölls, M. Gregoritza, R. Tantipolphan, M. Wiggenhorn, G. Winter, W. Friess, A. Hawe
How subvisible particles become invisible-relevance of the refractive index for protein particle analysis
J Pharm Sci 102 (5) (2013), 1434-1446. Epub 2013 Mar 5.
PMID: 23463514

A. Hawe, F. Schaubhut, R. Geidobler, M. Wiggenhorn, W. Friess, M. Rast, C. de Muynck, G. Winter
Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods
Eur J Pharm Biopharm 2013 Feb 27. Epub 2013 Feb 27. 
PMID: 23454051

E. E. Etzl, G. Winter, J. Engert
Toward intradermal vaccination: preparation of powder formulations by collapse freeze-drying
Pharm Dev Technol 19(2) (2014),213-223. Epub 2013 Feb 25. 
PMID:  23432539

M. Schwab, C. M. McGoverin, K. C. Gordon, G. Winter, T. Rades, J. Myschik, C. J. Strachan
Studies on the lipase-induced degradation of lipid-based drug delivery systems. Part II – Investigations on the mechanisms leading to collapse of the lipid structure
Eur J Pharm Biopharm 2013 Feb 4. Epub 013 Feb 4. 
PMID: 23385286

A. M. Youssef, G. Winter
A critical evaluation of microcalorimetry as a predictive tool for long term stability of liquid protein formulations: Granulocyte Colony Stimulating Factor  (GCSF)
Eur J Pharm Biopharm 84 (1) (2013), 145-155. Epub 2013 Jan 18 
PMID: 23333898

M. Noga, D. Edinger,  R. Kläger, S. V. Wegner, J. P. Spatz, E. Wagner, G. Winter, A. Besheer
The effect of molar mass and degree of hydroxyethylation on the controlled shielding and deshielding of hydroxyethyl starch-coated polyplexes
Biomaterials 34 (10) (2013), 2530-2538. Epub 2013 Jan 11. 
PMID: 23312901


V. Iyer, N. Maddux,  L. Hu, W. Cheng, A. K. Youssef, G. Winter, S. B. Joshi, D. B. Volkin, C. R. Middaugh
Comparative signature diagrams to evaluate biophysical data for differences in protein structure across various formulations
J Pharm Sci  102 (1)  (2013),43-51. Epub 2012 Nov 15.
PMID: 23160989

R. Geidobler, S. Mannschedel, G. Winter
A new approach to achieve controlled ice nucleation of supercooled solutions during the freezing step in freeze-drying
J  Pharm. Sci. 101 (12) (2012), 4409-4413. Epub 2012 Sep 10.
PMID: 22965644

G. Sax, B. Kessler, E. Wolf, G. Winter
In-vivo biodegradation of extruded lipid implants in rabbits
J Control Release 163 (2) (2012), 195-202. Epub 2012 Sep 1 
PMID: 22964393

G. Sax, G. Winter
Mechanistic studies on the release of lysozyme from twin-screw extruded lipid implants
J Control Release 163 (2) (2012), 187-194. Epub  2012 Sep 1.
PMID: 22964391

S. Buchmann, G.H. Sandmann, L. Walz, H. Hoppe, K. Beitzel, G. Wexel, W. Tian, G. Winter, A.B. Imhoff
Refixation of the supraspinatus tendon in a rat model - influence of continuous growth factor application on tendon structure
J Orthop Res. 31 (2) (2013), 300-305. Epub 2012 Aug 21
PMID: 22912341

T. Serno, E. Härtl, A. Besheer, R. Miller, G. Winter
The role of polysorbate 80 and HP β CD at the air-water interface of IgG solutions
Pharm Res. 30 (1) (2013), 117-130. Epub 2012 Aug 22.
PMID: 22910890

G. Sax, F. Feil, S. Schulze, Ch. Jung, Ch. Bräuchle, G. Winter
Release pathways of interferon α2a molecules from lipid twin screw extrudates  revealed by single molecule fluorescence microscopy
J Control Release 162 (2) (2012), 295-302. Epub 2012 Jul 20.
PMID: 22820452

K. Schersch, O. Betz, P. Garidel, S. Muehlau, S. Bassarab, G. Winter
Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins, Part 2: stability during storage at elevated temperatures
J Pharm Sci. 101 (7) (2012), 2288-2306. Epub 2012 Apr 19.
PMID: 22517663

Y. Deng, G. Winter, J. Myschik
Preparation and validation of a skin model for the evaluation of intradermal powder injection devices
Eur J Pharm Biopharm 81(2) (2012), 360-368. Epub 2012 Mar 30. 
PMID: 22484250

S. Fuchs, J. Klier , A. May, G. Winter, C. Coester C, H. Gehlen
Towards an inhalative in vivo application of immunomodulating gelatin nanoparticles in horse-related preformulation studies
J Microencapsul. 29 (7) (2012), 615-625. doi: 10.3109/02652048.2012.668962. Epub 2012 Mar 20. 
PMID: 22432849

J. Klier , S. Fuchs , A. May, U.  Schillinger, C. Plank, G. Winter, H. Gehlen, C. Coester
A nebulized gelatin nanoparticle-based CpG formulation is effective in immunotherapy of allergic horses
Pharm Res. 29 (6) (2012), 1650-1657. doi: 10.1007/s11095-012-0686-8.
Erratum in Pharm Res  29 (7) (2012), 2030. 
PMID: 22302522

M. Noga, D. Edinger, W. Rödl, E. Wagner, G. Winter, A. Besheer
Controlled shielding and deshielding of gene delivery polyplexes using hydroxyethyl starch (HES) and alpha-amylase
J Control Release 159 (1) (2012), 92-103.  Epub  2012 Jan 16. 
PMID: 22269664


W. Jiskoot, T. W. Randolph, D. B. Volkin, C. R. Middaugh, C. Schöneich, G. Winter, W. Friess W, D. J. Crommelin, J. F. Carpenter
Protein instability and immunogenicity: Roadblocks to clinical application of injectable protein delivery systems for sustained release
J Pharm Sci. 101 (3) (2012), 946-54. doi: 10.1002/jps.23018. Epub 2011 Dec 14.
PMID: 22170395

S. Zölls, R.Tantipolphan, M. Wiggenhorn, G. Winter, W. Jiskoot, W. Friess, A. Hawe
Particles in Therapeutic Protein Formulations, Part 1: Overview of Analytical Methods
J Pharm Sci. 101 (3) (2012), 914-35  
PMID: 22161573

M. Hofer, G. Winter, J. Myschik
Recombinant spider silk particles for controlled delivery of protein drugs
Biomaterials. 33 (5) (2012), 1554-62. Epub 2011 Nov 9

E. E. Kis, G. Winter, J. Myschik
Devices for intradermal vaccination
Vaccine 30 (3) (2011), 523-538. doi: 10.1016/j.vaccine.2011.11.020. Epub 2011 Nov 18.
PMID: 22100637

S. Bauersachs, S.E. Ulbrich, H.D. Reichenbach, M. Reichenbach, M. Büttner, H.H. Meyer, T.E. Spencer, M. Minten, G. Sax, G. Winter, E. Wolf.
Comparison of the effects of early pregnancy with human Interferon, Alpha 2
(IFNA2), on gene expression in bovine endometrium
Biol Reprod   86 (2) (2012), 1–15. doi: 10.1095/biolreprod.111.094771. Epub 2011 Oct 27.
PMID: 22034527

J. Klier, S. Fuchs, A. May, U. Schillinger, C. Plank, G. Winter, C. Coester, H. Gehlena
Immunostimulation of bronchoalveolar lavage cells from recurrent airway obstruction-affected horses by different CpG-classes bound to gelatin nanoparticles
Veterinary Immunology and Immunopathology 144 (2011), 79–87. doi: 10,1016/j.vetimm.2011.07.009. Epub 2011 Jul 20.
PMID: 21831455

T. Serno, R. Geidobler, G. Winter
Protein stabilisation by cyclodextrins in the liquid and dried state
Adv Drug Deliv Rev 63 (13) (2011), 1086-1106. 
PMID: 21907254

A. J. Freitag, K. Wittmann, I. Immohr, G. Winter, J. Myschik
Asymmetrical flow field-flow fractionation – a preparative tool to obtain endotoxin-free protein species
G.I.T. Laboratory Journal Europe 15 (2011), 11-12

S. P. Hertel, W. Friess, G. Winter
Comparison of aerosol collection methods for liquid protein formulations
RDD Europe 2 (2011), 345-350

T.R.M. De Beer, M. Wiggenhorn, A. Hawe, J.C. Kasper, A. Almeida,T. Quinten, W. Friess , G. Winter, C. Vervaet, J.P. Remon
Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers
Talanta 83 (5) (2011), 1623–1633. 
PMID: 21238761

A. J. Freitag, K. Wittmann, G. Winter, J. Myschik
The preparative use of flow field-flow fractionation (AF4)
LC GC Europe 24 (3) (2011), 134 – 140

A. Lammel, M. Schwab,  M. Hofer, G. Winter, T. Scheibel
Recombinant spider silk particles as drug delivery vehicles
Biomaterials 32 (8) (2011), 2233-2240. 
PMID: 21186052


S. Fuchs, M. Kutscher, T. Hertel, G. Winter, M. Pietzsch and C. Coester
Transglutaminase: new insights into gelatin nanoparticle cross-linking
J Microencapsul, 27 (8) (2010), 747–754. 
PMID: 21034367

S. Tinkov, C. Coester, S. Serba, N. A. Geis, H. A. Katus, G. Winter, R. Bekeredjian
New doxorubicin-loaded phospholipid microbubbles for targeted tumor therapy: Part II — In-vivo characterization
Journal of Controlled Release 148 (2010), 368–372. doi: 10.1016/j.jconrel.2010.09.004. Epub 2010 Sept 22.
PMID: 20868711

K.M. Hossann, T. Wang, M. Wiggenhorn, R. Schmidt, A.Zengerle, G.Winter, H. Eibl, M. Peller, M. Reiser, R. D. Issels, L. H. Lindner
Size of thermosensitive liposomes influences content release
J Control Release 147 (2010), 436–443. doi: 10.1016/j.jconrel.2010.08.013. Epub 2010 Aug 19.
PMID: 20727921.

K. Ofokansi, G. Winter, G. Fricker, C. Coester
Matrix-loaded biodegradable gelatin nanoparticles as new approach to improve drug loading and delivery
Eur J  Pharm Biopharm 76 (1) (2010), 1–9. 
PMID: 20420904

S. Fuchs, G. Winter and C. Coester
Ultrasonic resonator technology as a new quality control method evaluating gelatin nanoparticles
J Microencapsul 27 (3) (2010), 242-252. 
PMID: 20406094

C. Bourquin, C. Wurzenberger, S. Heidegger, S. Fuchs, D. Anz, S. Weigel, N. Sandholzer, G.Winter, C.Coester, S. Endres
Delivery of immunostimulatory RNA oligonucleotides by gelatin nanoparticles triggers an efficient antitumoral response
Journal of Immunotherapy 33 (9) (2010), 935-44

S. Tinkov, G. Winter, C. Coester, R. Bekeredjian
New doxorubicin-loaded phospholipid microbubbles for targeted tumor therapy : Part I - Formulation development and in-vitro characterization
J Control Release 143 (1) (2010), 143-150. 
PMID: 20060861

K. Schersch, O. Betz, P. Garidel, S. Muehlau, S. Bassarab, G. Winter
Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins I: Stability after freeze drying
J Pharm Sci 99 (5) (2010), 2256-2278. 
PMID: 20039389

W. Tian, S. Schulze, M. Brandl, G. Winter
Vesicular phospholipid gel-based depot formulations for pharmaceutical proteins: development and in vitro evaluation
J Control Release 142 (3) (2010), 319-325. 
PMID:  19925833

J. F. Carpenter, T. W. Randolph, W. Jiskoot, D. J. Crommelin, C. R. Middaugh, G. Winter
Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: Essential need to use orthogonal methods to assure the quality of therapeutic protein products
Pharm Sci 99 (5) (2010), 2200-2208. 
PMID: 19918982

T. Serno, J.F. Carpenter, Th. W. Randolph, G. Winter
Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-β-cyclodextrin
J Pharm Sci. 99 (3) (2010), 1193-1206. 
PMID:  19774651

R. Lang, L. Vogt, A. Zürcher, G. Winter
Virus-Like Particle Characterization Using New AF4 Channel Technology
American Laboratory 2010 April 02


R. Lang, L. Vogt, A. Zürcher, G. Winter
Asymmetrical Flow FFF as an Analytical Tool for the Investigation of the Physical Stability of Virus-Like Particles
LCGC North America 2009 Sept 1

T. De Beer, M. Wiggenhorn, R. Veillon, C. Debacq, Y. Mayeresse, B. Moreau, A. Burggraeve, W. Friess, G. Winter, C. Vervaet, J. P. Remon, W. Baeyens
The importance of using complementary process analyzers for the process monitoring, analysis and understanding of freeze drying
Anal Chem 81 (18) (2009), 7639-7649. 
PMID: 19681620

M. Schwab, G. Sax, S. Schulze, G. Winter
Studies on the lipase induced degradation of lipid based drug delivery systems
J Control Release. 140 (1) (2009), 27-33.  
PMID: 19619592

E. Rosenberg, S. Hepbildikler, W. Kuhne, G.Winter
Ultrafiltration Concentration of Monoclonal Antibody Intermediate Solutions: Development of an Optimized Method minimizing Aggregation
Journal of Membrane Science 342 (2009) 50–59, JMS-08967R1

S. Schultes, K. Mathis, J. Zillies, K. Zwiorek, C. Coester, G. Winter
Analysis of prototype polymers and protein nanoparticles with asymmetrical flow field-flow fractionation
LC-GC Europe 22 (8) (2009)

S. Fuchs, R. Parlitz, D. Gau, G., C. Coester
Ultrasonic resonator technology - A tool to fill a gap in analytics of nanoparticulate oligonucleotide drug delivery systems
J Microencaps 27 (3) (2010), 242-252

St. Tinkov, R. Bekeredjian, G. Winter, C. Coester
Characterization of ultrasound-mediated destruction of drug-loaded microbubbles using an improved in vitro model
Applied Acoustics 70 (10)  (2009) 1323–1329

F. Hoffmann, G. Sass, J. Zillies, St. Zahler, G. Tiegs, A. Hartkorn, J. Wagner, G. Winter, C. Coester, A.L. Gerbes, A. Vollmar
A novel technique for selective NF-kappaB inhibition in Kupffer cells shows contrary effects in fulminant hepatitis and ischemia-reperfusion
Gut  58 (12) (2009), 1670-1678. 
PMID: 19470497

S. Schulze, G. Winter
Lipid extrudates as novel sustained release systems for pharmaceutical proteins
J Control Release 134 (3) (2009), 177-185. 
PMID: 19121347

R. Lang, G. Winter, L.Vogt, A. Zürcher, B. Dorigo, B. Schimmele
Rational design of a stable, freeze-dried virus-like particle-based vaccine formulation
Drug Dev Ind Pharm 35 (1) (2009), 83-97. 
PMID: 19016059

St. Tinkov, R. Bekeredijan, G. Winter, C. Coester
Microbubbles as ultrasound triggered drug carriers
J Pharm Sci 98 (6) (2009), 1935-1961. 
PMID: 18979536


C. Bourquin, D. Anz, K. Zwiorek, A-L. Lanz, S. Fuchs, S. Weigel, C. Wurzenberger, P. von der Borch, M. Golic, S. Moder, G. Winter, C. Coester, S. Endres
Targeting CpG oligonucleotides to the lymph node by nanoparticles elicits efficient antitumoral immunity
J Immunol 181 (5) (2008), 2990-2998. 
PMID: 18713969

J. F. Carpenter, Th. W. Randolph, W. Jiskoot, D. J. Crommelin, C. Middaugh, G. Winter, Y. Fan, S. Kirshner, D. Verthelyi, St. Kozlowski, K. Clouse, P. Swann, A. Rosenberg, B. Cherney
Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality 
J Pharm Sci  98 (4) (2009), 1201-1205. 
PMID: 18704929

A. Lammel, M. Schwab, Ute Slotta, G. Winter, Th. Scheibel
Processing conditions for the formation  of spider silk microspheres
ChemSusChem, 1 (5) (2008), 413-416. 
PMID: 18702135

M. Schwab, B. Kessler, E. Wolf, G. Jordan, S. Mohl, G. Winter
Correlation of in vivo and in vitro release data for rh-INFalpha lipid implants
Eur J Pharm Biopharm 70 (2) (2008), 690-694. 
PMID: 18582576

J. Zillies, K. Zwiorek, F. Hoffmann, A. Vollmar, T. Anchordoquy, G. Winter, C. Coester
Formulation development of freeze-dried oligonucleotide-loaded gelatin nanoparticles
Eur J of Pharm Biopharm 70 (2) (2008), 514-521. 
PMID: 18582569

F. Siepmann, S. Herrmann, G. Winter, J. Siepmann
A novel mathematical model quantifying drug release from lipid implants
J Control Release 128 (3) (2008), 233-240. 
PMID: 18442866

K. Zwiorek, C. Bourquin, J. Battiany, G. Winter, S. Endres, G. Hartmann, C.Coester
Delivery by cationic gelatin nanoparticles strongly increases the immunostimulatory effects of CpG oligonucleotides
Pharm Res 25 (3) (2008), 551-562. 
PMID: 17912489


M. Hossann, M.Wiggenhorn, A.Schwerdt, K. Wachholz, N. Teichert, H. Eibl, R. D. Issels, L. H. Lindner
In vitro stability and content release properties of phosphatidylglyceroglycerol containing thermosensitve liposomes
Biochimica et Biophysica Acta (BBA) - Biomembranes,  1768 (10) (2007), 2491-2499.Epub 2007 Jun 2.
PMID: 17618599

R. Bekeredjian, R. Kroll, E.Fein, S. Tinkov, C. Coester, G. Winter, H.A. Katus, H.Kulaksiz
Ultrasound targeted microbubble destruction increases capillary permeability in hepatomas
Ultrasound Med. Biol. 33 (10) (2007), 1592-1598.  
PMID: 17618040

J.C. Zillies, K. Zwiorek, G. Winter, C. Coester
Method for quantifying the PEGylation of gelatin nanoparticle drug carrier systems using asymmetrical flow field-flow fractionation and refractive index detection
Anal. Chem. 79 (12) (2007), 4574-4580. 
PMID: 17506521

J. P. Gabrielson JP, M. L. Brader, A. H. Pekar, K. B.Mathis, G. Winter G, J. F. Carpenter, T. W.  Randolph TW.
Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity.
J Pharm. Sci.  96 (2) (2007), 268-279. 
PMID: 17080424

A. Stabenau, G. Winter
Application and drying of protein drug microdroplets on solid surfaces
Pharm Dev Technol 12 (1) (2007), 61-70 
PMID: 17484145

S. Herrmann, S. Mohl, F. Siepmann, J. Siepmann, G. Winter
New insight into the role of polyethylene glycol acting as protein release modifier in lipidic implants
Pharm. Res. 24 (8) (2007), 1527-1537 
PMID: 17380261

S. Hermann, G. Winter, S. Mohl, F. Siepmann, J. Siepmann
Mechanisms controlling protein release from lipidic implants: effects of PEG addition
J Control Release 118 (2007), 161-168 
PMID: 17275943

2006 and before

G. Winter
Steriltechnik in der Herstellung pharmazeutischer Produkte
Chemie Ingenieur Technik 78 (11) (2006), 1690-1696

T. Schönbrodt, S. Mohl, G. Winter, G. Reich
NIR spectroscopy – a non-destructive analytical tool for protein quantification within lipid implants
Journal Control Release, 114 (2006), 261-267. Epub 2006 Jun 2.
PMID: 16872710

S. Mohl, G. Winter
Continuous release of rh-interferon α-2a from triglyceride implants: storage stability of the dosage forms
Pharmaceutical Development and Technology, 11 (1) 2006, 103-110.
PMID: 16544914

M. Wiggenhorn, I. Presser, G. Winter
The current state of PAT in freeze-drying
American Pharmaceutical Review, January/February 2005, Volume 8 (1), 38–44
European Pharmaceutical Review 10 (4) (2005) 87-92

W.Fraunhofer, G. Winter
The use of asymmetrical flow field-flow fractionation in pharmaceutics and biopharmaceutics
Eur J Pharm Biopharm 58 (2) (2004), 369-383.
PMID: 15296962

S. Mohl, G. Winter
Continuous release of rh-interferon α-2a from triglyceride matrices
J. Control Release 97 (2004), 67-78.
PMID: 15147805

W. Fraunhofer, G. Winter, C. Coester
Asymmetrical flow field-flow fractionation and multiangle light scattering for analysis of gelatin nanoparticle drug carrier systems
Anal Chem 76 (7) (2004), 1909-1920.
PMID: 15053651

W. Fraunhofer, G. Winter, J. Zillies, C. Coester
Asymmetrical flow field-flow fractionation as new analytical tool in pharmaceutical biotechnology
New Drugs 2 March (2003), 16-19

K. Schumacher, G. Winter, H.-C. Mahler
Instabilitäten von Proteinarzneimitteln
PZ Prisma 10 (1) (2003), 15-18

C. Roth, G. Winter, G. Lee
Continuous measurement of drying rate of crystalline and amorphous systems during freeze-drying using an in situ microbalance technique
J. Pharm. Sci. 90 (9) (2001), 1345-1355.
PMID: 11745787

L.S. Jones, T.W. Randolph, U. Kohnert, A. Papadimitriou, G. Winter, M.-L. Hagmann, M.C. Manning, J.F. Carpenter
The effects of Tween 20 and sucrose on the stability of anti-L-selectin during lyophilization and reconstitution
J. Pharm. Sci. 90 (10) (2001), 1466-1477.
PMID: 11745706

K.F. Pistel, B. Bittner, H. Koll, G. Winter, T. Kissel
Biodegradable recombinant human erythropoietin loaded microspheres prepared from linear and star-branched block copolymers: Influence of encapsulation technique and polymer composition on particle characteristics
J. Control. Release 59 (1999), 309-325.
PMID: 10332063

M. Mattern, G. Winter, U. Kohnert, G. Lee
Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems
Pharm. Develop. Technol. 4 (2) (1999), 199-208.
PMID: 10231881

M. Morlock, T. Kissel, Y. Li, H. Koll, G. Winter
Erythropoietin loaded microspheres prepared from biodegradable LPLG-PEO-LPLG triblock copolymers: Protein stabilization and in-vitro release properties
J. Control. Release 56 (1998), 105-115
PMID: 9801434

B. Bittner, M. Morlock, H. Koll, G. Winter, T. Kissel
Recombinant human erythropoietin (rhEPO) loaded poly(lactide-co-glycolide) micropheres: influence of the encapsulation technique and polymer purity on microsphere characteristics
Eur. J. Pharm. Biopharm. 45 (1998), 295-305.
PMID: 9653634

M. Mattern, G. Winter, R. Rudolph, G. Lee
Formulation of proteins in vacuum-dried glasses. I. Improved vacuum-drying of sugars using crystallising amino acids
Eur. J. Pharm. Biopharm. 44 (2) (1997), 177-185

M. Morlock, H. Koll, G. Winter, T. Kissel
Microencapsulation of rh-erythropoietin, using biodegradable poly(D,L-lactide-co-glycolide): protein stability and the effects of stabilizing excipients
Eur. J. Pharm. Biopharm. 43 (1) (1997) 29-36

Ch. Gido, P. Langguth, J. Kreuter, G. Winter, H. Woog, E. Mutschler
Conventional versus novel conditions for the in vitro dissolution testing of parenteral slow release formulations: Application to doxepin parenteral dosage forms.
Pharmazie 48 (10) (1993), 764-769.
PMID: 8265710

G. Winter, G. Lee, H. Stricker
Dermal drug absorption and its in vitro simulation
Acta Pharm. Technol. 33 (1987), 233-234

H. Stricker, G. Winter, A. Leber
Galenische Faktoren der kutanen Wirkstoffpenetration in vivo
Acta Pharm. Technol. 33 (2) (1987), 80-87