BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...
BioPhorum deliverables report November 2020
BioPhorum is here to help you and your operations to make better decisions, faster. Membership puts you and your team in the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global focus to resolve.
This year, we celebrate reaching a major milestone with the development of our library of materials. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced by each Phorum over the last 12 months, including both those published in the public domain and reserved as ‘members-only’ materials.
The Report also provides commentary on the trends seen by the Phorums, their key priorities and any significant progress made against workstream milestones and missions.
Twelve years ago, we set out to connect industry and create a great place to benchmark. From this beginning, your ambitions as members have led to the development of more than 100 industry best practice documents and tools that are now accessible via our website.
What is notable is the increasing and continued acceleration in productivity that we are experiencing. Now, in 2020, we are forecasting the publication of another 100 best practices and guides in one year, a doubling in available output.
This Deliverables Report gives you a snapshot of the productivity of each Phorum over the last 12 months and an insight into what they are working on in 2021 and beyond.
As valued members in our collaboration, you can benefit today from the publications of tomorrow, as your subject matter experts will be immersed in the development of those practices many months before they see the light of publication.
The report is a substantial read. However, overleaf is a sample of some of the recent changes we have facilitated and the opportunities available to you:
- Thanks to our Post-Approval Strategy team, Anvisa changed its data requirements for post-approval change submissions from August 2020 when the new regulation was published. We are already aware of one member re-entering the Brazilian market as a result.
- To accelerate the adoption of new technologies and best practices, we are increasing our focus on aligning the necessary regulatory science with our technical positions. Implementing our regulatory and partnership strategy will help leverage an industry consensus with agencies, standards bodies and related trade organizations. A good example of this is the interaction with the USP across several BioPhorum topics, and we hope to announce a formalization of this relationship soon. This brings your collective voice to bear faster and more effectively in the USP monograms.
- A series of guides and studies developed with the PDA will be published that bring science into the debate on pre-use post-sterilization integrity testing (PUPSIT) of final filters, just as the redrafting of Annex 1 takes effect. We believe that this will enable you to make informed decisions on the deployment of PUPSIT in a sound, risk-based way.
- Seven years ago, we began helping members create much-needed standards for single-use systems and reduce their adoption times. This year has seen the revision of our first Extractables Protocol that reduces testing costs and increases user confidence. We have also launched the BioPhorum Extractables Portal that connects users with all the information they need from suppliers and connects suppliers with guidance documents and tools.
- The seven existing chapters of the Technology Roadmapping program have evolved to include an eighth chapter on digital technologies in development. Technology acceleration workstreams are translating recommendations into collaborative user requirements, such as:
- Those associated with in-line monitoring attributes for a biomanufacturing process
- Proofs of concept, such as the in-line buffer preparation skid being built and tested in conjunction with NIIMBL
- White papers on strategies and practices, including Knowledge Mapping in a CMC environment paper and tool.
- The publication Best practice in bioassay development to support registration of biopharmaceuticals has been downloaded more than 10,000 times, which should precede significant industry adoption. Also, the exciting new area of in-silico modeling creates the opportunity to reduce wasted experiments, lower costs and accelerate development if used effectively and consistently.
- Finally, the first three publications from BioPhorum Cell & Gene Therapy have been made available:
- Environmental health and biosafety risk assessment guidance for commercial-scale cell and gene therapy manufacturing
- Cell therapy and gene therapy process maps for the emerging CGT industry, which also provides a baseline for established experts to support collaboration, enabling process improvements and accelerating the commercialization of CGT products.
We hope you find this report informative, engaging and inspiring and look forward to hearing from you.
|BioPhorum Deliverables Report November 2020.pdf|
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