Raw Materials Sourcing

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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

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. 

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Raw Materials: Perspectives on raw and starting materials risk assessment for cell and gene therapy (CGT) processes

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.

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