Biotech organizations can encounter a variety of challenges, both expected and unexpected, during biopharmaceutical development. Anticipating and mitigating these challenges will ensure that the process development and manufacturing timelines and deliverables will be maintained. In this webinar industry experts will provide insights on how biotech organizations and their CDMO partners can effectively plan and execute a successful drug development program, from pre-clinical to IND. Two case studies will be presented that illustrate how analytical and process development activities are performed to meet timelines and process needs.
In this webinar, you will learn:
- Strategies used and activities performed to achieve high-concentration formulation to address client’s testing needs.
- Analytical and process development strategies that reduce the time required to produce biologics, while balancing risk and cost.
Speakers
Abigail Guce-Merriam, Ph.D.
Merck
Manager, Downstream Process Development
Abigail Guce-Merriam leads the downstream process development, located in our Burlington, MA, facility. Her group mainly focuses on client molecule downstream process development, process tech transfers to GMP production, and DS formulation study.
A biophysicist and structural biologist by training, she holds a Ph.D. from the University of Massachusetts-Amherst. Prior to joining the company in 2018, Abby was a downstream process development SME and protein purification expert in MassBiologics (CDMO) and UMASS Medical School Structural Lab.
Joshua Arias
Merck
Technical Lead, CDMO Services
As a technical lead in our company, Josh has served as a technical point of contact ensuring technical activities are completed on track. Josh has more than 25 years of experience in applied separations in the non-GMP pilot and GMP manufacturing environments, including managing clinic manufacturing operations in both upstream and downstream areas. His expertise includes technology transfer, process implementation, process monitoring, and troubleshooting investigations.
Josh is a chemical engineer and has a B.S from Worcester Polytechnic Institute and a M.E. degree from Tufts University.
Pharma and biopharma manufacturing
- mRNA
Durée:1h
Langue:English
Session 1:présenté(e) June 16, 2022
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