CGT raw materials


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Building on industry feedback to standardize plasmid release specifications

Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current regulatory guidance is limited in defining expectations for the release of plasmids as a starting material. BioPhorum has been highly active in this area and its most recent paper BioPhorum raw materials: cell and gene therapy critical starting material – further discussion on plasmids to establish release specifications...

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Raw materials strategy

This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.

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Discussion on plasmids to establish release specifications using a risk-based approach to manage supply

This paper shares industry feedback after the publication of two BioPhorum papers that complement ongoing efforts in the wider CGT field. It supplements these publications by delving into identity testing and cross-contamination for plasmid master cell banks and plasmid DNA, and other plasmid DNA release tests (including DNA homogeneity, residual DNA and host RNA, and sterility or bioburden).

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Why BioPhorum’s trace element approach will save you time, money and wasted batches

Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches worth millions of dollars are sometimes discarded due to trace elements coming through the supply chain. Not only does this increase costs and significantly impact production scheduling, but it could delay the manufacture of drugs that may, ultimately, impact patients. Yet, despite these industry-wide issues, there is no...

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Media and hydrolysates

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.

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A simplified way to register complex and innovative raw materials in Europe

The regulatory environment for registering innovative and complex raw materials differs by region and country. All national health agencies need to ensure that products proposed for their markets are safe, effective and of appropriate quality, so they need sufficient information to make that assessment. Most national health agencies have a knowledge platform where raw material suppliers can provide information on non-compendial materials –...

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