Benchmarking survey conducted to gain an early understanding of the AAV expression systems and viruses being used by Members. It seeks to understand if companies have been requested to complete specific viral clearance studies by regulatory agencies or if they have conducted them for their own purposes. The resulting data was used to drive discussion on the validation requirements of viral clearance studies within CGT products
The BioPhorum Report 2020 consists of industry views and opinions, and includes more than 50 interviews with industry leaders and subject matter experts. It highlights examples of how participating in BioPhorum, and applying best practices and learnings, have resulted in benefits for members, the industry and, ultimately, the patient.
As we find ourselves amid a global pandemic, BioPhorum’s collaborations and technical documents explore, propose and define industry best practices. The Report looks at how applying these guidelines can scale-up operations and get products to market faster, as well as delivering efficiency and cost benefits.
The purpose of this benchmarking survey was to understand the experiences of the Validation workstream community of technology transfers between CMOs and clients (developers) for either general or specific Cell & Gene Therapy products and identify lessons and opportunities to improve the process. The survey contains 3 sections covering introductory questions, guidelines for a transfer, and questions regarding experiences with transfers. The survey results highlight the critical points to focus upon during a New Product Introduction (NPI) kick-off meeting between a client and CMO for a cell or gene product and prompted the development of a checksheet for a kick-off meeting.
A well run and comprehensive New Product Introduction (NPI) kick-off meetings is critical to lay the foundations of clarity and understanding between a client and CMO for a successful cell or gene product technology transfer. This was the critical finding of a benchmark run by the Cell and Gene Therapy Phorum in late 2018. See the survey here. This conclusion prompted the development of a checksheet for a kick-off meeting.
The set of slides developed by the Phorum to guide one of these meetings is designed to ensure that both parties understand what should be discussed at the meeting and that expectations, roles, responsibilities and deliverables are agreed. The group believe that following hs template will reduce the potential for confusion and delays during product transfers – ensuring a faster and more effective product validation.
The leaders and representatives of the Cell and Gene Therapy Phorum have reviewed and provided feedback as part of the consultation with the EMA on thier the draft Regulatory Science to 2025, a strategy reflection document.
This benchmark survey was designed to help highlight the knowledge and experience of the Validation workstream members with regards to Cell & Gene Therapy (CGT) Validation. It's purpose was to help identify initial discussion points to create CGT specific templates / guidelines for unique CGT Validation aspects. The survey wa completed by 10 member companies and contains 3 sections covering general introductory questions, experience with CGT Validation, and thoughts on areas of high risk for CGT validation.