IP Library › Granted Patent US 12,371,510
Granted Patent B2
US 12,371,510 · App. 17/017,465 · Granted Jul 29, 2025

Process for concentration of antibodies and therapeutic products thereof

Inventor: Charles M. Winter (Belmont, CA)
Assignees: Genentech, Inc.; Novartis AG
C07K16/4291A61K39/39591B01D61/146B01D61/16C07K1/34C07K16/065B01D2311/04B01D2311/16C07K2317/21
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,371,510
App. No.
17/017,465
Granted
Jul 29, 2025
Kind
B2
Abstract

The present disclosure provides a process for concentrating proteins including an ultrafiltering, a diafiltering, and a second ultrafiltering sequence, at elevated temperatures, such as above about 30° C. The disclosure also includes a process for preparing highly concentrated antibody compositions, and highly concentrated antibody products.

Claims (8)

1. An ultrafiltration retentate diluted and conditioned to a final formulation comprising about 150 g/L (mg/ml) anti-IgE rhuMab E25 antibody, 0.02 M histidine, 0.2 M arginine-HCl, 0.04% polysorbate 20, pH 6, wherein the anti-IgE rhuMab E25 antibody is as described in U.S. Pat. No. 6,172,213, and wherein the ultrafiltration retentate is substantially free of soluble aggregates of the antibody.

2. An ultrafiltration retentate diluted and conditioned to a final formulation comprising about 150 g/L (mg/ml) anti-IgE rhuMab E25 antibody, 0.02 M histidine, 0.2 M arginine-HCl, 0.04% polysorbate 20, pH 6, wherein the ultrafiltration retentate was prepared at a temperature of about 45° C. plus or minus 5° C. and allowed to return to ambient temperature during dilution and conditioned, wherein the anti-IgE rhuMab E25 antibody is as described in U.S. Pat. No. 6,172,213, and wherein the ultrafiltration retentate is substantially free of soluble aggregates of the antibody.

3. The ultrafiltration retentate of claim 1 , wherein the level of the aggregates in the ultrafiltration retentate is less than 5 weight %.

4. The ultrafiltration retentate of claim 1 , wherein the level of the aggregates in the ultrafiltration retentate is less than 2 weight %.

5. The ultrafiltration retentate of claim 1 , wherein the level of the aggregates in the ultrafiltration retentate is about 1 weight %.

6. The ultrafiltration retentate of claim 2 , wherein the level of the aggregates in the ultrafiltration retentate is less than 5 weight %.

7. The ultrafiltration retentate of claim 2 , wherein the level of the aggregates in the ultrafiltration retentate is less than 2 weight %.

8. The ultrafiltration retentate of claim 2 , wherein the level of the aggregates in the ultrafiltration retentate is about 1 weight %.

Continuity (6)
Continuation 16752366 · Jan 24, 2020
Continuation 16447800 · Jun 20, 2019
Continuation 14257907 · Apr 21, 2014
Continuation 11220362 · Sep 6, 2005
Provisional Application 60609092 · Sep 9, 2004
Related Publication 20210095050A1 · Apr 1, 2021
References Cited (318)
US 4374763A · Takagi · 1983 [cited by applicant]
US 4485040A · Roger · 1984 [cited by applicant]
US 4576696A · Oertli · 1986 [cited by applicant]
US 4849508A · Magnin · 1989 [cited by applicant]
US 4897465A · Cordle · 1990 [cited by applicant]
US 5177194A · Sarno · 1993 [cited by applicant]
US 5252480A · Yokota et al. · 1993 [cited by applicant]
US 5256294A · Van Reis · 1993 [cited by applicant]
US 5580856A · Prestrelski et al. · 1996 [cited by applicant]
US 6103502A · Moeller · 2000 [cited by applicant]
US 6172213B1 · Lowman · 2001 [cited by applicant]
US 6252055B1 · Relton · 2001 [cited by applicant]
US 6875432B2 · Shire · 2005 [cited by applicant]
US 8961964B2 · Liu et al. · 2015 [cited by applicant]
US 10034940B2 · Liu et al. · 2018 [cited by applicant]
US 10370456B2 · Winter · 2019 [cited by applicant]
US 11767370B2 · Winter · 2023 [cited by applicant]
US 20020045571A1 · Liu et al. · 2002 [cited by applicant]
US 20020151688A1 · Ristol · 2002 [cited by applicant]
US 20030190316A1 · Kakuta · 2003 [cited by applicant]
US 20040167320A1 · Couto · 2004 [cited by applicant]
US 20060051347A1 · Winter · 2006 [cited by applicant]
US 20070237762A1 · Winter · 2007 [cited by applicant]
US 20090214522A1 · Winter · 2009 [cited by applicant]
US 20140370003A1 · Winter · 2014 [cited by applicant]
AU 2005285243B2 · 2012 [cited by applicant]
CN 1219882A · 1999 [cited by applicant]
EP 0025275A2 · 1981 [cited by applicant]
EP 0210039A2 · 1987 [cited by applicant]
EP 0210039A3 · 1988 [cited by applicant]
EP 0467482B1 · 1992 [cited by applicant]
EP 0210039B1 · 1993 [cited by applicant]
EP 0787497A2 · 1997 [cited by applicant]
EP 0909564A1 · 1999 [cited by applicant]
EP 0822752B1 · 2002 [cited by applicant]
EP 1197221A1 · 2002 [cited by applicant]
EP 1780830A1 · 2007 [cited by applicant]
EP 2292636A2 · 2011 [cited by applicant]
EP 1610820B2 · 2013 [cited by applicant]
EP 1786830B1 · 2014 [cited by applicant]
EP 2335725B1 · 2016 [cited by applicant]
EP 2116265B1 · 2020 [cited by applicant]
EP 3805248A2 · 2021 [cited by applicant]
EP 4104859A1 · 2022 [cited by applicant]
EP 4108259A1 · 2022 [cited by applicant]
EP 3805248B1 · 2023 [cited by applicant]
EP 2292636B9 · 2024 [cited by applicant]
EP 4108259B1 · 2024 [cited by applicant]
JP S60214738A · 1985 [cited by applicant]
JP 6485929A · 1989 [cited by applicant]
JP H04198195A · 1992 [cited by applicant]
JP 05065295A · 1993 [cited by applicant]
JP H08205888A · 1996 [cited by applicant]
JP 9512267A · 1997 [cited by applicant]
JP 9512529A · 1997 [cited by applicant]
JP 2001516599A · 2001 [cited by applicant]
RU 2140287C1 · 1999 [cited by applicant]
WO 199006764A1 · 1990 [cited by applicant]
WO 199528951A1 · 1995 [cited by applicant]
WO 199528954A1 · 1995 [cited by applicant]
WO 199704801A1 · 1997 [cited by applicant]
WO 199726909A1 · 1997 [cited by applicant]
WO 199745140A1 · 1997 [cited by applicant]
WO 199915024A1 · 1999 [cited by applicant]
WO 200024266A2 · 2000 [cited by applicant]
WO 200024266A3 · 2000 [cited by applicant]
WO 200103515A1 · 2001 [cited by applicant]
WO 2001024814A1 · 2001 [cited by applicant]
WO 200213860A1 · 2002 [cited by applicant]
WO 0230463A2 · 2002 [cited by applicant]
WO 0230463A3 · 2002 [cited by applicant]
WO 2003009817A2 · 2003 [cited by applicant]
WO 2003039485A2 · 2003 [cited by applicant]
WO 2003042344A2 · 2003 [cited by applicant]
WO 2003072060A2 · 2003 [cited by applicant]
WO 2003042344A3 · 2003 [cited by applicant]
WO 2004001007A2 · 2003 [cited by applicant]
WO 2004042012A2 · 2004 [cited by applicant]
WO 2004001007A3 · 2004 [cited by applicant]
WO 2004055516A1 · 2004 [cited by applicant]
WO 2004076695A1 · 2004 [cited by applicant]
WO 2004091658A1 · 2004 [cited by applicant]
WO 2004042012A3 · 2004 [cited by applicant]
WO 2005073252A1 · 2005 [cited by applicant]
WO 2005082109A2 · 2005 [cited by applicant]
WO 2006031560A2 · 2006 [cited by applicant]
WO 2006031560A3 · 2006 [cited by applicant]
Anonymous (Jun. 2003). “Protein Concentration and Diafiltration by Tangential Flow Filtration,” located at http://www.millipore.com/techpublications/tech1/tb032, last visited on Apr. 12, 2006, 20 pages. [cited by applicant]
Campbell, M.J. et al. (1993). “Effect of Temperature on Protein Conformation and Activity During Ultrafiltration,” Journal of Membrane Science 78:35-43. [cited by applicant]
Communication Pursuant to Article 94(3) EPC, European Examination Report for European Patent Application No. 10 009 914.2, dated Nov. 5, 2018, filed on Sep. 20, 2010, 3 pages. [cited by applicant]
Genentech, Inc. (2008). “Process Characterization Summary Report,” Genentech, Inc., 6 pages. [cited by applicant]
International Search Report dated Apr. 27, 2006, for PCT Application No. PCT/US2005/031844, filed on Sep. 8, 2005, 3 pages. [cited by applicant]
Lipnizki, F. et al. (2002). “Concepts of Industrial-Scale Diafiltration Systems,” presented at the International Congress of membranes and Membrane Processes (ICOM), Toulouse, France, Desalination 144:179-184. [cited by applicant]
Liu, C. et al. (1998). “Optimization of Operation Parameters in Ultrafiltration Process,” J. Biotechnology 66:195-202. [cited by applicant]
Sawada, K. et al. (1992). “Selective Removal of Anti-Acetylcholine Receptor Antibody in the Low Temperature Operation of Membrane Plasma Fractionation,” J. Clin. Apher. 7(2):81-86. (Abstract Only). [cited by applicant]
Schwartz, L. (2003). “Diafiltration: A Fast, Efficient, Method for Desalting, or Buffer Exchange of Biological Samples,” located at http://www.pall.com/pdf/02.0629_Buffer_Exchange_STR.pdf, last visited on Apr. 12, 2006,… [cited by applicant]
Song, H-X. et al. (Feb. 2003). “Studies on Separation of IgY by Ultrafiltration,” Journal of Shaanxi University of Science & Technology 21(1):44-46. (Chinese Language with certified English Translation, seven pages.). [cited by applicant]
U.S. Metric Association. (2012). “Metric System Temperature (Kelvin and Degree Celsius),” located at http://lamar.colostate.edu/˜hillger/temps.htm, last visited on Jul. 7, 2014, 4 pages. [cited by applicant]
Van Den Berg, G.B. et al. (1990). “Flux Decline In Ultrafiltration Processes,” Desalination 77:101-133. [cited by applicant]
Van Reis, R. et al. (1997). “Constant Cwall Untrafiltration Process Control,” J. Membrane Science 130:123-140. [cited by applicant]
Vermeer, A.W.P. t al. (Jan. 2000). “The Thermal Stability of Immunoglobulin: Unfolding and Aggregation of a Multi-Domain Protein,” Biophysical Journal 78(1):394-404. [cited by applicant]
Wagner, J. (Nov. 2001). Membrane Filtration Handbook Pratical Tips and Hints, Second Edition, Revision 2, pp. 1-127. [cited by applicant]
Winter, C.M. (Nov. 18, 2002). “High Concentration Formulation of RhuMAbs by Ultrafiltration,” Biopharmaceutical Product Week, Abstract located at http://www.LifeSciencesInfo.com, last visited Oct. 30, 2002, 2 pages. [cited by applicant]
Written Opinion dated Apr. 27, 2006, for PCT Application No. PCT/US2005/031844, filed on Sep. 8, 2005, 5 pages. [cited by applicant]
Yao, H-J. et al. (Dec. 2003). “Operation Modes of Pressure-Driven Membrane Processes and Their Optimization,” Membrane Science and Technology 23(6):38-43. (Chinese Language with certified English Translation, 13 pages.). [cited by applicant]
Zeman, L.J. et al. (1996). “Proces Configurations,” Chapter 8 in Microfiltration and Ultrafiltration. Principles and Applications, Marcel Dekker, Inc., New York, New York, pp. 394-395. [cited by applicant]
Zydney, A.L. et al. (2000). “Protein Concentration and Buffer Exchange Using Ultrafiltration,” Chapter 3 in Methods in Biotechnology, Desal, M.A., ed., Humana Press, Totowa, New Jersey, pp. 23-34. [cited by applicant]
Anonymous. (2002). “Omalizumab,” Biodrugs 16:380-386. [cited by applicant]
Busse, W.W. (2002). “Anti-Immunoglobulin E (Omalizumab) Therapy in Allergic Asthma,” Am J Respir Crit Care Med. 164:S12-S17. [cited by applicant]
Chen, B. et al. (2003). “Influence of Histidine on the Stability and Physical Properties of a Fully Human Antibody in Aqueous and Solid Forms,” Pharm Res 20(12): 1952-1960. [cited by applicant]
Communication Pursuant to Article 94(3) EPC, dated Jan. 31, 2022, for European Patent Application No. 20200642.5, filed on Oct. 7, 2020, 6 pages. [cited by applicant]
European Search Report dated Jun. 10, 2021, for European Patent Application No. 20200642.5, 19 pages. [cited by applicant]
European Search Report dated Mar. 11, 2021, for European Patent Application No. 20200642.5, 15 pages. [cited by applicant]
World Health Organization. (2000). “Proposed INN: List 84,” WHO Drug Information 14(4):263. [cited by applicant]
World Health Organization. (2001). “Recommended INN: List 46,” WHO Drug Information 15(3-4):205. [cited by applicant]
Liu et al. (Sep. 2005). “Reversible Self-Association Increases the Viscosity of a Concentrated Monoclonal Antibody in Aqueous Solution,” J. Pharm. Sci. 94(9): 1928-1940. [cited by applicant]
Daugherty, A. L. et al. (2006). “Formulation and Delivery Issues for Monoclonal Antibody Therapeutics, ” Advanced Drug Delivery Reviews 58:686-706. [cited by applicant]
Nayar, R. et al. (2002) “Chapter 8 - High Throughput Formulation: Strategies for Rapid Development of Stable Protein Products,” In Carpenter & Manning (eds.) Rational Design of Stable Protein Formulations, pp. 177-198. [cited by applicant]
Shiraki, K. et al. (2002). “Biophysical Effect of Amino Acids on the Prevention of Protein Aggregation,” Biochem. 132:591-595. [cited by applicant]
Tomar, D.S. et al. (2017). “In-Silico Prediction of Concentration-Dependent Viscosity Curves for Monoclonal Antibody Solutions,” MABS 9(3):476-489. [cited by applicant]
Tsumoto, K. et al. (2004). “Role of Arginine in Protein Refolding, Solubilization and Purification,” Biotechnol. Prog. 20(5): 1301-1308. [cited by applicant]
U.S. Appl. No. 60/460,659, filed Apr. 4, 2003, 100 pages. [cited by applicant]
Wang, W. et al. (2007). “Antibody Structure, Instability, and Formulation,” J. Pharm. Sci. 96(1):1-26. [cited by applicant]
Xie, Q. et al. (2004). “The Guanidine Like Effects of Arginine on Aminoacylase and salt-Induced Molten Globule State,” Int. J. Biochem. Cell Biol. 36:296-306. [cited by applicant]
XOLAIR® (2003). FDA Label—“Omalizumab,” 17 pages. [cited by applicant]
XOLAIR® (2005). “Scientific Discussion,” European Public Assessment Report. 34 pages. [cited by applicant]
XOLAIR® (2023). “Summary of Product Characteristics,” European Public Assessment Report. 182 pages. [cited by applicant]
Yadav, S. et al. (2011). “Establishing a Link Between Amino Acid Sequences and Self-Associating and Viscoelastic Behavior of Two Closely Related Monoclonal Antibodies,” Pharm. Res. 28:1750-1764. [cited by applicant]
European Patent No. 1610820 B1 (EP Appln. No. 04759018.7) Supplementary data submitted by Proprietor with the letter dated, Sep. 9, 2012, 4 pages. [cited by applicant]
European Patent No. 1610820 B1 (EP Appln. No. 04759018.7) Decision of Opposition Division, Dec. 12, 2012, 16 pages. [cited by applicant]
European Patent No. 1786830 B1 (EP Appln. No. 05806393.4) Decision of Opposition Division, Nov. 16, 2017, 25 pages. [cited by applicant]
European Patent No. 2292636 B9 (EP Appln. No. 10009914.1) Decision of Technical Board of Appeal, May 5, 2022, 14 pages. [cited by applicant]
European Patent No. 3805248 B1 (Ep Appln. No. 20200642.5) Rule 58 EPC Communication, Oct. 28, 2020, 1 page. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Response to Rule 58 EPC Communication, Nov. 3, 2020, 8 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) European Search Report, May 31, 2021, 7 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Search Opinion, Jun. 10, 2021, 10 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Response to Search Opinion, Jul. 26, 2021, 23 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Third Party Observations, Sep. 22, 2021, 3 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Response to Third Party Observations, Oct. 4, 2021, 2 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Examination Report, Jan. 31, 2022, 4 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Response to Examination Report, Apr. 13, 2022, 6 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Third Party Observations, May 24, 2022, 13 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Third Party Observations, Aug. 23, 2022, 4 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Intention to Grant, Dec. 2, 2022, 10 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Communication of Further Notices of Opposition pursuant to Rule 79(2) EPC by Celltrion, Inc., Nov. 2, 2023, 51 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Communication of Further Notices of Opposition pursuant to Rule 79(2) EPC by Kilburn & Strode LLP, Nov. 2, 2023, 33 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration of H.W. Frijlink, Jan. 11, 2024, 16 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Response to Notices of Opposition, Mar. 4, 2024, 33 pages. [cited by applicant]
Ahn, J.H. et al. (1997). “Investigation of Refolding Condition for Pseudomonas fluorescens Lipase by Response Surface Methodology,” Journal of Biotechnology 54:151-160. [cited by applicant]
Arakawa, T. et al. (2001). “Factors Affecting Short-Term and Long-Term Stabilities of Proteins,” Advanced Drug Delivery Reviews 46:307-326. [cited by applicant]
Arakawa, T. et al. (2003). “Effects of Protein Stabilizers on Aggregation Inducted by Multiple-Stresses,” The Yakugaku Zasshi 123(11):957-961. [cited by applicant]
Arakawa, T. et al. (2003). “The Effects of Arginine on Refolding of Aggregated Proteins: Not Facilitate Refolding, but Suppress Aggregation,” Biochemical and Biophysical Communication 304:148-152. [cited by applicant]
Arakawa, T. et al. (2004, e-pub. May 20, 2004). “Elution of Antibodies From a Protein-A col. by Aqueous Arginine Solutions,” Protein Expression and Purification 36:244-248. [cited by applicant]
Buchner, J. et al. (1992). “A Method for increasing the Yield of Properly Folded Recombinant Fusion Proteins: Single-Chain Immunotoxins from Renaturation of Bacterial Inclusion Bodies,” Analytical Biochemistry 205(2):26… [cited by applicant]
Carpenter, J.F. et al. (1998). “Application of Infrared Spectroscopy to Development of Stable Lyophilized Protein Formulations,” European Journal of Pharmaceutics and Biopharmaceutics 45:231-238. [cited by applicant]
Carpenter, J.F. et al. (1999). “Inhibition of Stress-Induced Aggregation of Protein Therapeutics,” Methods in Enzymology 309:236-255. [cited by applicant]
Carpenter, J.F. et al. (2002). “Long-Term Storage of Proteins,” in Current Protocols in Protein Science, John Wiley & Sons, Inc. Supplement 27, 4.6.1-4.6.6, 6 pages. [cited by applicant]
Carpenter, J.F. et al. (1997) “Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice,” Pharmaceutical Research 14(8): 969-975. [cited by applicant]
Chang, B.S. et al. (2002). “Chapter 1: Practical Approaches to Protein Formulation Development,” in Carpenter & Manning (eds.), Rational Design of Stable Protein Formulations, Kluwer Academic / Plenum Publishers, pp. 1-… [cited by applicant]
Chi, E. et al. (2003) Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation, Pharmaceutical Research 20(9): 1325-1336. [cited by applicant]
Das, D. et al. (2004). “Development of a Biotin Mimic Tagged ScFv Antibody Against Western Equine Encephalitis Virus: Bacterial Expression and Refolding,” Journal of Virological Methods 117:169-177. [cited by applicant]
European Medicines Agency (Mar. 21, 2024). “Omalizumab, Summary of Opinion,” 2 pages. [cited by applicant]
European Medicines Agency (Oct. 23, 2014). “Guidelines on Similar Biological Medicinal Products,” 7 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration and CV of H.W. Frijlink, filed in Writ of Summons dated Oct. 9, 2023, [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration of Professor Daan Crommelin, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Extract From Register of European Patents, retrieved Apr. 4, 2024, 8 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Response to Third Party Observations, Jul. 18, 2022, 5 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Technical Background on Histidine Chemistry, filed in [cited by applicant]
Georgiou, G. et al. (1996). “Expression of Correctly Folded Proteins in Escherichia coli,” Current Opinion in Biotechnology 7:190-197. [cited by applicant]
Horan, T.P. et al. (1997). “Dimerization of Granulocyte-Colony Stimulating Factor Receptor: The Ig Plus CRH Construct of Granulocyte-Colony Stimulating Factor Receptor Forms 2:2 Complex with a Ligand,” J. Biochem. 121:3… [cited by applicant]
Hsu, C.C. et al. (1995). “Surface Denaturation of Solid-Void Interface - A Possible Pathway by Which Opalescent Particulates Form During the Storage of Lyophilized Tissue-Type Plasminogen Activator at High Temperatures,… [cited by applicant]
Manning, M.C. et al. (1995). “Approaches For Increasing the Solution Stability of Proteins,” Biotechnology and Bioengineering 48:506-512. [cited by applicant]
Menzella, H.G. et al. (2002). “High Recovery of Prochymosin From Inclusion Bodies Using Controlled Air Oxidation,” Protein Expression and Purification 25:248-255. [cited by applicant]
Nelson, D.L. & Cox, M.M. (2000). Lehninger Principles of Biochemistry, 3rd edition, Nelson & Cox (eds.), Worth Publishers, New York, NY, various extracts, 47 pages. [cited by applicant]
Oberg, K. et al. (1994). “Nativelike Secondary Structure in Interleukin-1B Inclusion Bodies by Attenuated Total Reflectance FTIR,” Biochemistry 33(9): 2628-2634. [cited by applicant]
Rinas, U. et al. (1990). “Denaturation-Renaturation of the Fibrin-Stabilizing Factor XIII a-Chain Isolated from Human Placenta: Properties of the Native and Reconstituted Protein,” Biol. Chem. Hoppe-Seyler 371:49-56. [cited by applicant]
Rudolph, R. et al. (1996). “In Vitro Folding of Inclusion Body Proteins,” The FASEB Journal 10:50-56. [cited by applicant]
Schulze, E. et al. (1887). “Über das Arginin,” Zeitschrift für Physiologische Chemie, 11(1-2):43-65. English translation by machine with original German reference, 46 pages. [cited by applicant]
Schaffner, J. et al. (2001). “Cosecretion of Chaperones and Low-Molecular-Size Medium Additives Increases the Yield of Recombinant Disulfide-Bridged Proteins,” Applied and Environmental Microbiology 67(9): 3994-4000. [cited by applicant]
Soejima, K. et al. (2001). “An Efficient Refolding Method for the Preparation of Recombinant Human Prethrombin-2 and Characterization f the Recombinant-Derived a-Thrombin,” J. Biochem. 130:269-277. [cited by applicant]
Sörensen, S.P.L. (1910). “Über die Synthese des dl-Arginins (a-Amino-o-guanido-n-valeriansäure) und der isomeren a-Guanido-o-amino-n-valeriansäure,” Berichte der deutschen chemischen Gesellschaft, 43(1):643-651. English… [cited by applicant]
Tsumoto, K. et al. (2003). “Practical Consideration in Refolding Proteins from Inclusion Bodies,” Protein Expression and Purification 28:1-8. [cited by applicant]
Tsumoto, K. et al. (2003). “Solubilization of Active Green Fluorescent Protein from Insoluble Particles by Guanidine and Arginine,” Biochemical and Biophysical Research Communication 312:1383-1386. [cited by applicant]
Turker, M. et al. (1987). “Membrane Fouling in a Constant-Flux Ultrafiltration Cell,” Journal of Membrane Science 34:267-281. [cited by applicant]
Umetsu, M. et al. (Mar. 14, 2003). “How Additives Influence the Refolding of Immunoglobulin-Folded Proteins in a Stepwise Dialysis System,” The Journal of Biological Chemistry 278(11): 8979-8987. [cited by applicant]
Urieto, J.O. et al. (2004). “Expression and Purification of the Recombinant Diphtheria Fusion Toxin DT388IL3 for Phase | Clinical Trials,” Protein Expression and Purification 33: 123-133. [cited by applicant]
Wang, W. (1999). “Instability, Stabilization, and Formulation of Liquid Protein Pharmaceuticals,” International Journal of Pharmaceutics 185:129-188. [cited by applicant]
Wang, W. (2000). “Lyophilization And Development Of Solid Protein Pharmaceuticals,” International Journal Of Pharmaceutics 203:1-60. [cited by applicant]
Wang, W. (2005) “Protein Aggregation and its Inhibition in Biopharmaceutics,” International Journal of Pharmaceutics 289:1-30. [cited by applicant]
Wang, Y.- C. J. et al. (1988). “Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers,” Journal of Parenteral Science and Technology, 46:S4-S24, 24 pages. [cited by applicant]
Wright, E. et al. (2004). “Isolation of Aminoglycoside Nucleotidyltransferase(2')'la from Inclusion Bodies as Active, Monomeric Enzyme,” Protein Expression and Purification 35:373-380. [cited by applicant]
XOLAIR® (2021) U.S. Prescribing Information, 52 pages. [cited by applicant]
XOLAIR® (2022) Safety Data Sheet, 22 pages. [cited by applicant]
Zbacnik, T.J. et al. (2017, e-pub. Nov. 26, 2016). “Role of Buffers in Protein Formulations,” Journal of Pharmaceutical Sciences 106:713-733. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Technical Background, filed in Writ of Summons dated Oct. 9, 2023, [cited by applicant]
Crommelin, D.J.A. et al. (2002). Pharmaceutical Biotechnology: Fundamentals and Applications, 2nd edition, Taylor & Francis, excerpt from Chapter 4, 74-75, 4 pages. [cited by applicant]
Dent, G. (2003). “IgE Modulation in Asthma,” Expert Opin. Ther. Patents 13(10): 1607-1617. [cited by applicant]
PubMed (2024). Search for rhumAb E25 + Omalizumab + Xolair in years 2001-2004, 3 pages. [cited by applicant]
Cacia, J. et al. (1996). “Isomerization of an Aspartic Acid Residue in the Complementarity-Determining Regions of a Recombinant Antibody to Human IgE: Identification and Effect on Binding Affinity,” Biochemistry 35(6): … [cited by applicant]
European Patent No. 1610820 B1 (EP AppIn No. 04759018.7) Response to Notice of Opposition, Jan. 24, 2012, 17 pages. [cited by applicant]
European Patent No. 2335725 B1 (EP Applin. No. 10008980.4) Response to Examination Report, Oct. 31, 2013, 3 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Request for Acceleration of Opposition Proceeding, May 22, 2024, 73 pages. [cited by applicant]
Presta, L.G. et al. (Sep. 1, 1993). “Humanization of an Antibody Directed Against IgE,” J. Immunol. 151 (5):2623-2632. [cited by applicant]
Ames, S.A. et al. (Mar. 2004). “Fresh From the Pipeline: Omalizumab,” Nature Reviews Drug Discovery 3:199-200. [cited by applicant]
AVASTIN@ [Bevacizumab] (Feb. 2004). Package Insert, Genentech, Inc., South San Francisco, CA, 5 pages. [cited by applicant]
Ayres, J.G. et al. (2004). “Efficacy and Tolerability of Anti-Immunoglobulin E Therapy with Omalizumab in Patients with Poorly Controlled (Moderate-to-Severe) Allergic Asthma,” Allergy 59:701-708. [cited by applicant]
Baynes, B.M. et al. (2004). “Rational Design of Solution Additives for the Prevention of Protein Aggregation,” Biophysical Journal 87:1631-1639. [cited by applicant]
Baynes, B.M. et al. (2005). “Role of Arginine in the Stabilization of Proteins Against Aggregation,” Biochemistry 44:4919-4925. [cited by applicant]
Beasley, R. (2004). “Examining the Unmet Need in Inadequately Controlled Severe Allergic Asthma,” screen shot from The ERS International Congress 2004, Glasgow, website, 2 pages. [cited by applicant]
BEXXAR® [Tositumomab] (Jun. 2003). Package Insert, Corixa Corp., Seattle, WA and GlaxoSmithKline, Philadelphia, PA, 11 pages. [cited by applicant]
British Thoracic Society (Apr. 2004). “British Guideline on the Management of Asthma,” 93 pages. [cited by applicant]
Buhl, R. et al. (2002). “Omalizumab Provides Long-Term Control in Patients with Moderate-to-Severe Allergic Asthma,” Eur. Respir. J. 20:73-78. [cited by applicant]
Busse, W. et al. (2001). “Omalizumab, Anti-IgE Recombinant Humanized Monoclonal Antibody, for the Treatment of Severe Allergic Asthma,” J. Allergy Clin. Immunol. 108(2): 184-190. [cited by applicant]
CAMPATH® [Alemtuzumab] (Apr. 2004). Package Insert, BERLEX® Laboratories, Montville, NJ, 4 pages. [cited by applicant]
Clayden et al. (2001). “Acidity, Basicity, and pKa,” in Organic Chemistry 1st Edition, Outline, Contents and Chapter 8. pp. 181-208, 44 pages. [cited by applicant]
ERBITUX® [Cetuximab] (Jun. 2004). Package Insert, Bristol-Myers Squibb Company, Princeton, NJ, 3 pages. [cited by applicant]
European Medicines Agency and European Commission (2019). “Biosimilars in the EU: Information Guide for Healthcare Professionals,” 40 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Brief Communication of Acceleration of Opposition Proceedings, Jun. 17, 2024, 1 page. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration and CV of Attorney J.B. Beeksma, filed in Deed Containing the Submission of Further Exhibits dated Aug. 7, 2024, [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration and CV of Prof. D. Crommelin, filed in Deed Containing the Submission of Further Exhibits dated Aug. 7, 2024, [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Declaration and Annex of Prof. Frijlink dated Jun. 26, 2024, filed by Celltrion, Inc. in Opposition Proceedings on Jul. 3, 2024, 19 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Declaration and CV of Prof. T. Dingermann dated Jun. 26, 2004, filed by Celltrion, Inc. in Opposition Proceedings on Jul. 3, 2024, 17 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Declaration and Resume of Dr. de Leede dated Jun. 26, 2024, filed by Celltrion, Inc. in Opposition Proceedings on Jul. 3, 2024, 27 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5). Response to O1's Submission, filed by Genentech, Inc. and Novartis AG in Oral Proceedings on Jun. 11, 2024, 10 pages. [cited by applicant]
FDA (Jul. 2, 2024). “Biological Product Definitions,” U.S. Food & Drug Administration, 2 pages. [cited by applicant]
Frokjaer, S. et al. (2000). Except from “Peptides and Proteins as Parental Solutions” in Pharmaceutical Formulation Development of Peptides and Proteins, pp. 150-153, 6 pages. [cited by applicant]
Genentech, Inc. (Jun. 30, 2004). U.S. Securities and Exchange Commission, Form 10-Q, 48 pages. [cited by applicant]
Giancola, C. et al. (1997). “DSC Studies on Bovine Serum Albumin Denaturation Effects of lonic Strength and SDS Concentration,” International Journal of Biological Macromolecules 20:193-204. [cited by applicant]
Global Initiative for Asthma (2004). “Global Strategy for Asthma Management and Prevention,” 199 pages. [cited by applicant]
HERCEPTIN® [Trastuxumab] (Oct. 2003). Package Insert, Genentech, Inc., South San Francisco, CA, 5 pages. [cited by applicant]
Holgate, S.T. et al. (2004). “Efficacy and Safety of a Recombinant Anti-Immunoglobulin E Antibody (Omalizumab) in Severe Allergic Asthma,” Clin. Exp. Allergy 34:632-638. [cited by applicant]
Humbert, M. et al. (2005). “Benefits of Omalizumab as Add-On Therapy in Patients with severe Persistent Asthma who are Inadequately Controlled Despite Best Available Therapy (GINA 2002 Step 4 Treatment): INNOVATE,” Alle… [cited by applicant]
HUMIRA® [Adalimumab] (Jul. 2004). Package Insert, Abbott Laboratories, North Chicago, IL, 2 pages. [cited by applicant]
Isi Web of Science (2005). Tutorial (v6.0), retrieved from the Internet: http://web.archive.org/web/20040228084928/www.isinet.com/tutorials/wos6/wos6tut11.html, last visited Jul. 5, 2024, 1 page. [cited by applicant]
Jiskoot, W. et al. (2022, e-pub. Nov. 20, 2021). “Ongoing Challenges to Develop High Concentration Monoclonal Antibody-Based Formulation for Subcutaneous Administration: Quo Vadis?” J. of Pharm. Sci. 111:861-867. [cited by applicant]
Kohn, W.D. et al. (1997). “Salt Effects on Protein Stability: Two-Stranded α-Helical Coiled-Coils Containing Inter- or Intrahelical Ion Pairs,” J. Mol. Biol. 267: 1039-1052. [cited by applicant]
Lanier, B.Q. et al. (2003). “Omalizumab is Effective in the Long-Term Control of Severe Allergic Asthma,” Ann. Allergy Asthma Immunol. 91:154-159. [cited by applicant]
Li, S. et al. (1996). “Effects of Reducing Sugars on the Chemical Stability of Human Relaxin in the Lyophilized State,” J. of Pharm. Sci. 85(8):873-877. [cited by applicant]
Li, S. et al. (996). “Inhibitory Effect of Sugars and Polyols on the Metal-Catalyzed Oxidation of Human Relaxin,” J. of Pharm. Sci. 85(8): 868-872. [cited by applicant]
McLellan, D. et al. (Jan. 1, 2004). “Drug Criteria & Outcomes: Formulary Evaluation of Omalizumab (Xolair)®,” Relais Media, 10 pages. [cited by applicant]
Milgrom, H. et al. (1999). “Treatment of Allergic Asthma with Monoclonal Anti-IgE Antibody,” The New England Journal of Medicine 341(26): 1966-1973. [cited by applicant]
Milgrom, H. et al. (2001). “Treatment of Childhood Asthma with Anti-Immunoglobulin E Antibody (Omalizumab),” Pediatrics 108(2):1-10. [cited by applicant]
MYLOTARG® [Gemtuxumab Ozogamicon] (undated) Package Insert, Wyeth Laboratories, Philadelphia, PA, 4 pages. [cited by applicant]
Nelson, D.L. et al. (2000). “Amino Acids, Peptides, and Proteins,” in Lehninger Principles of Biochemistry, 3rd Edition, Worth Publishers, New York, NY, Table of Contents and Chapter 5, pp. 115-158, 61 pages. [cited by applicant]
Nelson, D.L. et al. (2000). “Water,” in Lehninger Principles of Biochemistry, 3rd Edition , Worth Publishers, New York, NY, Table of Contents and Chapter 4, pp. 82-114, 47 pages. [cited by applicant]
OMLYCLO [Omalizumab] (2024). EPAR, Product Information, 87 pages. [cited by applicant]
Parkins, D.A. et al. (2000). “The Formulation of Biopharmaceutical Products,” Pharmaceutical Science & Technology 3(4):129-137. [cited by applicant]
Randolph, T.W. et al. (2002). “Surfactant-Protein Interactions,” in Rational Design of Stable Protein Formations, Carpenter and Manning (eds.), Kluwer Academic/Plenum Publishers, New York, 17 pages. [cited by applicant]
RAPTIVA® [Efalizumab] (Oct. 2003). Package Insert, Genentech, Inc., South San Francisco, CA, 3 pages. [cited by applicant]
Reichert, J.M. (2012). “Marketed Therapeutic Antibodies Compendium,” mAbs 4(3):413-415. [cited by applicant]
REMICADE® [Infliximab] (May 2004). Package Insert, Centocor, Inc., Malvern, PA, 3 pages. [cited by applicant]
REOPRO® [Abciximab] (Nov. 1997). Package Insert, Eli Lilly and Company, Indianapolis, IN, 3 pages. [cited by applicant]
RITUXAN® [Ritoximab] (Nov. 1997). Package Insert, IDEC Pharmaceuticals Corporation, San Diego, CA and Genentech, Inc., South San Francisco, CA, 2 pages. [cited by applicant]
Roefs, S.P.F.M. et al. (1994). “A Model for the Denaturation and Aggregation of β-Lactoglobulin,” Eur. J. Biochem. 226:883-889. [cited by applicant]
Roskos, L.K. et al. (2004). “The Clinical Pharmacology of Therapeutic Monoclonal Antibodies,” Drug Development Research 61:108-120. [cited by applicant]
Shire, S.J. et al. (2004). “Challenges in the Development of High Protein Concentration Formulations,” J. of Pharm. Sci. 93(6):1390-1402. [cited by applicant]
SIGMA-ALDRICH (Jun. 28, 2024). Product Specification of L-Histidine Monohydrochloride Monohydrate, H5659, 2 pages. [cited by applicant]
SIGMA-ALDRICH (Jun. 28, 2024). Product Specification of L-Histidine, H8000, 1 page. [cited by applicant]
SIMULECT® [Basiliximab] (Nov. 2003). Package Insert, Novartis Pharmaceuticals Corporation, East Hanover, NJ, 5 pages. [cited by applicant]
Solèr, M. et al. (2001). “The Anti-IgE Antibody Omalizumab Reduces Exacerbations and Steroid Requirement in Allergic Asthmatics,” Eur. Respir J. 18:254-261. [cited by applicant]
Strickley, R.G. et al. (2021, e-pub. Mar. 28, 2021). “A Review of Formulations of Commercially Available Antibodies,” J. of Pharm. Sci. 110:2590-2608, 75 pages. [cited by applicant]
SYNAGIS® [Palivizumab] (Dec. 1999). Package Insert, MedImmune, Inc., Gaithersburg, MD and Ross Products Division of Abbott Laboratories, Inc., Columbus, OH, 3 pages. [cited by applicant]
U.S. Pharmacopeial Convention (2002). USP NF, United States Pharmacopeia, “1049—Quality of Biotechnological Products: Stability Testing of Biotechnological Biological Products,” 7 pages. [cited by applicant]
U.S. Pharmacopeial Convention (2003) USP Dictionary of USAN and International Drug Names, U.S. Pharmacopeia, Omalizumab, 6 pages. [cited by applicant]
Voet, D. et al. (1999). “Water,” Fundamentals of Biochemistry, 1st Edition, Table of Contents and Chapter 2, pp. 23-38, 30 pages. [cited by applicant]
XOLAIR® (2023). Excerpt from EPAR Product Information for Omalizumab, 2 pages. [cited by applicant]
XOLAIR® (2024) Instructions for Use Prefilled Syringe, 39 pages. [cited by applicant]
XOLAIR® (2024). European Medicines Agency screenshot, retrieved from the Internet, https://www.erna.europa.eu/en/medicines/human/EPAR/xolair, last visited Aug. 12, 2024, 8 pages. [cited by applicant]
XOLAIR® (2024). Omalizumab: Description and Brand Names, Mayo Clinic screenshot, retrieved from the Internet https://www.mayclinic.org/drugs-supplements/omalizumab-subcutaneous-route/proper-use/drg-20065207?p=1, last vi… [cited by applicant]
XOLAIR® [Omalizumab] (2003). Package Insert, Genentech, Inc., South San Francisco, CA and Novartis Pharmaceuticals Corporation, East Hanover, NJ, 2 pages. [cited by applicant]
ZENAPAX® [Daclizumab] (Jul. 2003). Package Insert, Hoffmann-La Roche Inc., Nutley, NJ, 3 pages. [cited by applicant]
ZEVALIN® [Ibritumomab Tiuxetan] (Dec. 2001). Package Insert, IDEC Pharmaceuticals Corporation, San Diego, CA, 7 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Letter from Opponent 1 filed by Celltrion, Inc. in Opposition Proceedings on Jul. 3, 2024, 60 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Letter from Patentees filed by Genentech, Inc. & Novartis AG in Opposition Proceedings on Aug. 5, 2024, 10 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Letter from Opponent 1 filed by Celltrion, Inc. in Opposition Proceedings on Aug. 16, 2024, 53 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Summons to Attend Oral Proceedings Pursuant to Rule 115(1) EPC mailed in Opposition Proceedings on Sep. 2, 2024, 33 pages. [cited by applicant]
AllergyUK (Sep. 2021). “Your Quick Guide To: Peanut Allergy,” 4 pages. [cited by applicant]
Borchers, A.T. et al. (2004). “The Diagnosis and Management of Anaphylaxis,” Comp. Ther. 30(2):111-120. [cited by applicant]
British National Formulary 47 (Mar. 2004) British Medical Association, Royal Pharmaceuticals of Great Britian, 4 pages. [cited by applicant]
British National Formulary 48 (Sep. 2004) British Medical Association, Royal Pharmaceuticals of Great Britian, 5 pages. [cited by applicant]
Buchner, J. et al. (1991). “Renaturation, Purification and Characterization of Recombinant Fab-Fragments Produced in [cited by applicant]
Carpenter, J.F. et al. (2002). “Rational Design of Stable Protein Formulations: Theory and Practice,” Pharmaceutical Biotechnology, Preface and Table of Contents, 11 pages. [cited by applicant]
Carpenter, J.F. et al. (2002) “Chapter 5—Rational Design of Stable Protein Formulations: Theory and Practice,” In Carpenter & Manning (eds.) Rational Design of Stable Protein Formulations, pp. 109-133. [cited by applicant]
Dalby, I. (2016) “Enable Rapid Liquid and Freeze-Dried Formulation Design for the Manufacture and Delivery of Novel Biopharmaceuticals,” EPSRC Reference: EP/N025105/1, Details of Grant, 2 pages. [cited by applicant]
Davis, L.A. (2004, e-pub. Jun. 8, 2004). “Omalizumab: A Novel Therapy for Allergic Asthma,” Ann. Pharmacother. 38:1236-1242. [cited by applicant]
European Medicines Agency (2007). European Public Assessment Report (EPAR) Raptiva, 3 pages. [cited by applicant]
European Medicines Agency (2019). Summary of Opinion on REMSIMA [Infliximab], 1 page. [cited by applicant]
European Patent No. 3370770 B1 (EP Appln. No. 16862791.7) Expert Declaration of Paul Dalby, dated May 2002, filed by Janssen Biotech, Inc. in Opposition Proceedings on May 12, 2022, 20 pages. [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Third Expert Declaration of H.W. Frijlink, dated Sep. 3, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration of A. Obermeier, dated Sep. 3, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Declaration of D. Crommelin, dated Sep. 13, 2024, in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Fourth Expert Declaration of H.W. Frijlink, dated Oct. 22, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Report and CV of Neil Barnes, dated Jul. 4, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Report and CV of Paul Dalby, dated Jul. 5, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Report and CV of Ian Pavord, dated Jul. 5, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Expert Report and CV of Bernhardt Levy Trout, dated Jul. 5, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Second Expert Report of Neil Barnes, dated Aug. 9, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Second Expert Report of Paul Dalby, dated Aug. 9, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (Ep Appln. No. 20200642.5) Second Expert Report of Ian Pavord, dated Aug. 9, 2024, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Second Expert Report of Bernhardt Levy Trout dated Aug. 9, 2024 with redactions, filed in [cited by applicant]
European Patent No. 3805248 B1 (EP Appln. No. 20200642.5) Third Expert Report of Ian Pavord, dated Oct. 21, 2024, filed in [cited by applicant]
European Patent No. 41082259 B1 (EP Appln. No. 22178117.2) Response to Summons to Attend Oral Proceedings, Sep. 27, 2023, 3 pages. [cited by applicant]
European Patent No. 41082259 B1 (EP Appln. No. 22178117.2) Communication of a Notice of Opposition pursuant to Rule 79(2) EPC by Celltrion, Inc., Oct. 9, 2024, 27 pages. [cited by applicant]
European Respiratory Annual Society Congress from Sep. 4-8, 2004, Glasgow, Scotland, Scientific Programme, 16 pages. [cited by applicant]
Green, R.H. et al. (2003). “Management of Asthma in Adults: Current Therapy and Future Directions,” Postgrad Med. J. 79:259-267. [cited by applicant]
Hermeling, S. et al. (2003). “Micelle-Associated Protein in Epoetin Formulations: A Risk Factor for Immunogenicity?” Pharmaceutical Research 20(12): 1903-1907. [cited by applicant]
Jang, J. (Jan. 14, 2019). “Celltrion Applies for ‘Remsima SC’ Patents in 90 Countries,” [email protected], 3 pages. [cited by applicant]
Maurer, M. et al. (2022). “Pharmacokinetic Equivalence of CT-P39 and Reference Omalizumab in Healthy Individuals: A Randomised, Double-Blind, Parallel-Group, Phase 1 Trial,” Clin. Transl. Allergy e12204, 9 pages. [cited by applicant]
MERCK Safety Data Sheet for Polysorbate 20 (2022), 10 pages. [cited by applicant]
Mieczkowski, C.A. et al. (2023, e-pub. Apr. 8, 2023). “The Evolution of Commercial Antibody Formulations,” Journal of Pharmaceutical Sciences 112:1801-1810. [cited by applicant]
Mittal, K.L. (1970). “Determination of CMC of Polysorbate 20 in Aqueous Solution by Surface Tension Method,” Journal of Pharmaceutical Sciences, 61(8): 1334-1335. [cited by applicant]
Oxford BRC Screenshot of “Breakthroughs in Asthma Treatment” YouTube video of I. Pavord, dated May 30, 2019, 1 page. [cited by applicant]
Pandya, A. et al. (2018). “An Evaluation of the Potential of NMR Spectroscopy and Computational Modelling Methods to Inform Biopharmaceutical Formulations,” Pharmaceutics 10:165, 24 pages. [cited by applicant]
Ruffin, C.G. et al. (Jul. 15, 2004). “Omalizumab: A Recombinant Humanized Anti-IgE Antibody for Allergic Asthma,” Am. J. Health-Syst. Pharm. 61:1449-1459. [cited by applicant]
U.S. Appl. No. 10/813,483, Declaration and CV of Jun Liu, dated Sep. 4, 2008, 11 pages. [cited by applicant]
U.S. Pat. No. 8,562,999 Declaration, CV and List of Materials Considered of Paul Dalby, dated Sep. 13, 2017, filed by Wyeth LLC in Inter Partes Review Case No. IPR No. 2017-00378, 87 pages. [cited by applicant]
U.S. Pat. No. 8,580,264 Transcript of Deposition of Paul Dalby, dated Dec. 2, 2022, filed by Celltrion, Inc. in Inter Partes Review Case No. IPR No. 2022-00578, 23 pages. [cited by applicant]
Zarbin, M. (2020). “The Development Pathway for Biosimilar Biotherapeutics,” J. Ophthalmic Vis. Res. 15 (3):273-274. [cited by applicant]
Cited By (1)
US 12,492,265