CSS - Agenda
Tuesday, March 15, 2016
Victor Vinci, Ph.D., Chief Scientific Officer and Vice President, Cook Pharmica LLC.
Case StudyNew DataInnovative Technologies for the Expression of Next Generation Bio Therapeutics
To increase titer and improve product quality, such as glycosylation pattern, companies have relied on high throughput clone screening, media screening, and process optimization. With newly available genome data and technologies such as CRISPR and cellular engineering, it is now possible to achieve high titer and excellent product quality while shortening time and reducing cost.
Amita Goel, MSc., Founder and CEO, Celltheon
Adapting Process Development capabilities for a Modality Independent Strategy
Amgen's R&D strategy focuses on "Biology first" approach and advancing the best molecular entity to serve our patients. Process development is taking a systematic approach to the development of molecular entities that begins with pre-defined objectives, and emphasizes molecule selection, product and process understanding, including attribute control, based on scientific principles and quality risk management. As the understanding matures, Platform approaches are established for new modalities for effectiveness. This integrated product development paradigm starts with a well-defined TPP and QTPP to guide patient focused development and life-cycle-management. In this presentation, we will share our progress in application of a TPP and QTPP and adaptation of technologies for a modality independent strategy.
Rohini Deshpande, Ph.D., Executive Director, Process and Product Development, Amgen, Inc.
(co-authored by Alison Moore, Ph.D., Senior Vice President, Process Development, Amgen, Inc.)
Unleashing the Power of Innovation to Tackle Biomanufacturing's GreatestChallenges, Fuel Growth and Drive Value Creation
Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc.