In Biologics Therapeutics Manufacturing, an appropriate raw material management strategy in a systematic manner is a key factor to ensure the production success and the continuity of supply chain. Compared to the innovator companies, Contract Development and Manufacturing Organization have more raw material management challenges as they try to meet specific customer needs, which can be variable. This presentation will highlight an effective raw material management strategy developed at PSG-Biologics Thermo Fisher to overcome the challenges introduced by these variables, including the definition of platform raw materials and varied material specifications by customers. A couple of case studies are used to showcase the effectiveness of this approach, to address the challenges of platform materials and the discrepancy between the USP and EU requirements.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QA/QC analysts
R&D scientists, managers
Team members in CMC development projects
Manufacturing scientists, managers
Regulatory affairs specialists
Contract research organizations
Contract manufacturing organizations