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...
The supply of cell and gene therapies (CGTs) involves new levels of collaborative partnership and coordination between organizations. Identifying what each organization does and how it interacts with the others in a coordinated way is a complex challenge. IT solutions...
A survey was used to gather initial data to benchmark member company experience with replication competent AAV testing (Dec 2021). Members working with in vivo gene therapies using AAV were invited to complete the survey. Members were asked: What are the typical...
A cross collaboration of members participated in a series of meetings to review FDA Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial which was published for public...
Cell therapy manufacturing comprises several open and manual operations, which increase the risk of contamination. To address this risk, BioPhorum’s Cell & Gene Therapy Commercialization Workstream has generated a ‘mock’ process detailing the manufacture of a...
