Raw Materials Program
A program driving more predictable raw material (RM) performance, with workstreams focusing on two technical aspects: media and analytics and standards and procedures.
Driving more predictable raw material (RM) performance, optimized testing regimes and raw material flexibility
The aim of the program is drive the adoption of the industry-aligned Raw Materials (RM) strategy by tackling the root causes of RM variability and lack of harmonized specifications. This will enable more predictable raw material performance, optimized testing regimes and greater raw material flexibility: reducing supply continuity risk and enabling greater supply chain agility.
Media and Analytics: Eliminating unnecessary tests using critical attributes
Sharing best practices, knowledge, and experience to enhance the understanding and control of general raw materials and components of cell culture media, by identifying critical material attributes. The workstream is to develop a guideline/white paper that assists biomanufacturers and suppliers in identifying critical attributes of media subcomponents and establishing controls for Certificate of Analysis (COA) and specifications, thus eliminating the need for unnecessary tests.
Standards and Procedures: Better control of endotoxin levels
Advance Industry knowledge on how to better control endotoxin levels, by understanding the raw materials and their impact on the process through benchmarking. This will generate shared learning on endotoxin limits, preferred test methods, issues/corrective actions caused by endotoxin and approaches to endotoxin and bioburden specification setting.
Raw Materials Program deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.