The BioPhorum Gene-Editing subteam have produced a member only tool enabling the end-user to determine comparisons between different gene-editing techniques and delivery methods which can be used in cell and gene therapy drug product development and manufacture. The tool allows the user to form individual conclusions based on the users' requirements.
A BioPhorum member survey looking at sterility and bioburden testing during batch manufacture/release testing of gene therapy products within BioPhorum C> member companies. The results are available to members of BioPhorum C>.
In its current state, cell therapy manufacturing comprises several open and manual operations which increase the risk of contamination. Members of BioPhorum’s Cell & Gene Therapy Commercialization workstream have generated a ‘mock’ process detailing the manufacture of a generic autologous CAR-T product operated through a series of process steps combining some open and some closed system elements. The mock process has undergone an end-to-end closure analysis to identify those operations that pose the highest contamination risks, and to provide suggested mitigation solutions to minimize such risks. Suggestions include options that are currently available, as well as potential future ‘desired state’ options. This paper details the full process and summarizes potential risks and possible mitigations. The primary aim of this paper is to demonstrate systematic application of a closure analysis method on an ex vivo gene therapy (also known as gene-modified cell therapy) process so that organizations can apply similar analyses to their own processes. The secondary aim is to propose process closure solutions that companies could implement in their own operations.
This paper highlights the numerous challenges in validating cell and gene therapy (CGT), drug substance (DS) and drug product (DP) manufacturing processes and analytical methods. It showcases some of the challenges associated with validation of viral vector-mediated gene therapy and gene-modified cellular therapy manufacturing processes and analytical methods validation and offers potential solutions for these. It aims to make readers more aware of the complexity and challenges associated with validating CGT products and the industry-wide consensus in addressing some of these to help drive regulatory acceptance.
A BioPhorum member only survey on stability testing in cell and gene therapy.
A BioPhorum member only survey to gather opinion on potency and Infectivity testing in cell and gene therapy.
A BioPhorum member only survey identifying member input on container closure integrity testing and reserve sample testing in CGT.