High-concentration protein therapeutics, e.g. monoclonal antibodies, are considered as alternative and convenient application routes for injectables. Such formulations can be attained through optimization of formulation buffer to reduce viscosity, ultrafiltration device design to accommodate higher viscosity streams, and system design to allow low shear and low volume processing. In this pilot-scale study, we demonstrate the impact of optimized cassette design and the use of single-pass TFF (SP-TFF). Combining these approaches with excipients from the Viscosity Reduction Platform, concentration limits could be significantly pushed (> 300g/L) and protein stability was maintained.
Speakers
Can Araman, Ph.D.
Merck
Senior Manager, Lab Head
Can Araman is a senior manager heading the protein formulation laboratory in Merck's process solutions department in Darmstadt, Germany. His team is working on delivering solutions to challenges in protein formulations stemming mainly from the viscosity and aggregation of proteins. Can holds a Ph.D. from the Institute of Biological Chemistry in Vienna and has had a long-lasting experience in protein biochemistry, including antibody and ADC development for pre-clinical studies and clinical trials.
Akshat Gupta, Ph.D.
Merck
Associate Director, Global BioPharma Center of Excellence
Akshat Gupta is the associate director of applications engineering, Global Biopharma Center of Excellence. Akshat has more than 10 years of experience in the biopharmaceutical industry, focused on process development and manufacturing sciences. His areas of specialization include cell culture clarification and tangential flow filtration. He holds an M.S. and a Ph.D. in chemical engineering from the University of Massachusetts, Lowell, where is also an adjunct faculty member in the chemical engineering department.
Pharma and biopharma manufacturing
- Monoclonal antibody manufacturing
期間:1h
言語:English
セッション 1:presented December 5, 2023
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