665 Innovations in Biopharmaceutical Discovery, Development, and Manufacturing


Description:
This session will focus on innovations and advances within the biopharmaceutical industry, including, but not limited to, the area of bioprocess development and manufacturing. Topics of interest include: implementation of innovative technologies across scales, new applications of process analytics (PAT), multivariate (MVA) or other statistical analyses, scale-up/scale-down modeling and related concerns, and improvements in process robustness. In addition, process control for optimizing bioreactor performance and product quality control at manufacturing scale will be highlighted.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B), Bio Separations (02G)


Chair:
Elcin Icten
Amgen

Email: eicten@amgen.com

Co-Chair:
Colin Walters
Celgene

Email: cwalters@celgene.com


Papers:
665a
Impurity Rejection in Crystallization –Quantification and Mechanisms
Fredrik Nordstrom, Boehringer-Ingelheim
665b
Bi-Directional Control of Glycosylation of Antibodies
Madiha Khurshid, Amgen; Tony Wang, Amgen; Erin Franco, Amgen; Nelson Chavez, Amgen; Eleanor Le, Amgen; Richard Wu, Amgen; Randy Schweickart, Amgen; Jack Chung-Jr Huang, Amgen
665c
Bioprocess Optimization for Production of Recombinant Proteins in Chinese Hamster Ovary Cells in Consideration of Metabolic Shifts By Shear Stress
Keisuke Shibuya, Hitachi, Ltd. Research and Development Group; Kenichiro Oka, Hitachi, Ltd. Research and Development Group
665d
Using Machine Learning Tools in Bioprocess Scale up When the Number of Batches Is Small
Viktor Konakovsky, Fujifilm Diosynth Biotechnologies; Graham McCreath, Fujifilm Diosynth Biotechnologies; Jarka Glassey, Newcastle University
665e
A Workflow-Based Framework for Managing Product Analytical Data and Statistical Results for Lot Release
Girish Joglekar, Purdue University; Qing Cai, Long Island University; Poching DeLaurentis, Purdue University; Linas Mockus, Purdue University; Kenneth Morris, Long Island University; Gintaras V. Reklaitis, Purdue University
665f
Evaluation of Recovery Pathways for Improved Bioavailability of Clofazimine Nanoparticles
Jie Feng, Princeton University; Yingyue Zhang, Princeton University; Hoang Lu, Princeton University; Simon A. McManus, Princeton University; Robert K. Prud’homme, Princeton University
665g
Assessment of the Impact of Interfacial and Shear Stress on Biologics Drug Product Via Mini-Piloting Tools
Maria Olu Ogunyankin, Bristol-Myers Squibb Co.; Smeet Deshmukh, Bristol-Myers Squibb Co.; Masano Huang, Bristol-Myers Squibb Co.; Thiago Carvalho, Bristol-Myers Squibb Co.; Mary Krause, Bristol-Myers Squibb Co.; Brenda Remy, Bristol-Myers Squibb Co.; Mehrnaz Khossravi, Bristol-Myers Squibb Co.
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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