This paper gives a best practice recommendation for fingerprinting cell culture media. It includes a standardized analytical test method suite, a three-tier testing approach and flowcharts that guide the reader to choose a suitable media fingerprinting method based on their goals and the raw material properties.
Raw Materials Sourcing
Viewing related articles
A survey to understand what the industry current understanding of the FDA approach to fresh versus cryopreserved apheresis as a starting material for autologous/allogenic cell therapy programs.
A BioPhorum member only deliverable describing the work of the Plasmids subteam
This paper discusses the issues around trace elements and gives a suggested approach for developing a method for analyzing trace elements in cell culture media and hydrolysates. The approach is based on a ground breaking BioPhorum collaboration that shared blinded data and compared analytical methods between biopharmaceutical and media manufacturers.
BioPhorum member only survey exploring how member companies are using leukopaks and the key challenges facing the industry.
Two BioPhorum member only blinded surveys to gather data on the use of transfection reagents.
Raw materials: Cell and gene therapy critical starting material: a discussion to help establish release specifications for plasmids and the bacterial master cell banks used to produce them
BioPhorum Cell and Gene Therapy is asking for your help – and is giving you the opportunity to have a say in a scientific community discussion that will influence its suggested testing practices for plasmid release specifications. The team is proposing a platform framework for testing plasmid master cell banks and plasmid DNA.
Raw Materials: Perspectives on raw and starting materials risk assessment for cell and gene therapy (CGT) processes
The risk assessment of raw materials in the biopharmaceutical industry has been the subject of much study and review. The cell and gene therapy (CGT) field has the potential to revolutionize the healthcare industry. It utilizes novel manufacturing processes and has distinctive requirements for raw or starting materials. This paper outlines some of the unique challenges for raw materials as addressed by CGT manufacturers when working with the suppliers of materials. Case studies are presented to provide practical examples of the application of a risk matrix approach to the CGT industry and to highlight some challenges of managing raw materials for CGT manufacturing.