Role of Key Raw Materials in Improving Yield and Safety in Biomanufacturing

Tuesday, October 22, 2024

9:30 AM – 10:30 AM MT

Location:360 Stage #4, Exhibit Hall

Sponsored By

Manufacturing and Analytical Characterization

Partner Presentation-Manufacturing & Bioprocessing

Partner Presentation Speaker(s)

Sreejit Menon, PhD

Head of Life Sciences R&D, North America
Croda Inc.
Plainsboro, New Jersey
Garima Sinha, PhD

Lead Applications Scientist
Croda Pharma
Plainsboro, New Jersey

Description: The biomanufacturing process consists of several critical stages that impact the final yield and safety profile of biological products. Two pivotal factors in this process involve maintaining cell health during the upstream phase and viral inactivation during the downstream phase. Using high-purity, low molecular-weight poloxamer 188 in cell culture media enhances cell health. Subsequently, during downstream processing to meet the FDA's viral inactivation requirement, a non-ionic, sustainable detergent can significantly reduce the viral burden.

Learning Objectives:

Improving cell health in biomanufacturing
Improving safety profile by increasing viral clearance using a sustainable alternative to TritronX100 detergent
Critical quality attributes of raw materials in bioprocessing and the importance of batch-to-batch consistency