BioPhorum Report 2020

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 BioPhorum Report 2020 includes articles on a range of BioPhorum activities across the product lifecycle, for example:

Drug Substance

From BioPhorum Drug Substance, one article focuses on the complex challenges that companies face when introducing industry-wide changes. Meeting these challenges to build momentum for change is the reason why the Drug Substance Phorum has developed a leaner and more focused program for 2020. Diego Schmidhalter, Director of the Single-use Network at Lonza said. “Having a steering committee in place is important to oversee activity. To support implementation of a BioPhorum single-use workstream outcome, we set up a global single-use network with coordinators.

Fill Finish

Following the 2017 EMA directive in Annex 1 that pre-use, post-sterilization integrity tests (PUPSIT) are now expected for final sterilization filters, BioPhorum and the PDA formed the Sterile Filtration Quality Risk Management (SFQRM) Consortium. This has been working tirelessly to provide objective, unbiased, scientific data to help guide informed decisions about sterile filtration control measures and prepare extensively for the next version of Annex 1. In this article, Maik Jornitz, President and CEO of G-CON Manufacturing, said, “We finally have scientific data. It’s a great basis to work from and was much needed, not only for the industry but also for regulators, because now both can work from the same platform and work together on a risk assessment and test protocol.”

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