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Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance
This paper provides an in-depth exploration of the characteristics of SARS-CoV-2 (the virus) and COVID-19 (the disease). It also discusses how likely these may impact current control strategies that maintain product quality, safety and efficacy in the biopharmaceutical industry. It covers the areas that need to be assessed by biomanufacturers regarding SARS-CoV-2 risks for their patients, employees and products. Mitigation actions for the risks and associated benefits are also proposed. Just as importantly, it also discusses the areas that do not need to be evaluated – as current control strategies for endogenous and exogenous viruses, standards of work and the GMP framework are appropriate to prevent SARS-CoV-2 impacting on product. This is the case when the characteristics of SARS-CoV-2 do not make it unique when compared to the existing controls in place.
May 2020 | BioPhorum
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.
May 2019 | BioPhorum
This year’s report focuses on industry trends, current and emerging issues, and workstream results from across the Phorums. We look at how the development and recent launch of the alignment model helps to promote alignment across SMEs, leaders and executives roles, enabling senior sponsorship, providing best-practice approaches to drive implementation and communication, and enhancing benefit realization from workstreams. The Development Group takes us through significant updates from bioassays to small-scale models to viral clearance. While collaboration is at the heart of a story on PUPSIT (Pre-Use Post-Sterilization Integrity Testing), which focuses on how BioPhorum and the PDA are working with members to accelerate an industry response to an EU directive. We also discover how a meeting with the FDA supports momentum to foster regulatory discussions and hastens the adoption and successful implementation of advances in microbial control manufacturing and technology.
May 2018 | BioPhorum
Aug 2017 | BioPhorum