Course Description:
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.
The live version of this recording took place on April 16, 2021 and features
a presentation by Min Zhang, Ph.D.
Who should participate:
- 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
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.