Minimizing the Impact of Stability Testing on Low-Yield Biopharmaceuticals
In this episode of BioPhorum connect, we explore the newly published ASTM International standard guide 'Guide for Minimizing the impact of stability testing on batch yield of low yield biopharmaceutical products.'This guide, authored by BioPhorum members, builds on a foundational BioPhorum publication developed through collaboration among 12 companies in the Advanced Therapy Medicinal Products (ATMP) space, particularly focused on gene therapies.Simon Walker, Global Change Facilitator at BioPhorum, is joined by two key contributors to both the original BioPhorum deliverable and the ASTM guide:Gael Debauve, Head of Gene Therapy Analytical Sciences at UCBMadison Lee, Associate Director of CMC Program Management at RegeneronTogether, they discuss:Why minimizing the impact of stability testing is critical for low-yield productsHow the ASTM International guide expands the scope beyond gene therapiesThe value of using a mock gene therapy product to quantify potential savingsWho in the industry will benefit most from this guidanceThe collaborative advantage of working through BioPhorumWhether you're in QC, QA, regulatory affairs, or CMC leadership, this episode offers valuable insights into improving efficiency and conserving product in early-stage development.
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Cybersecurity in biomanufacturing: Insights from industry practitioners
Join us for an insightful episode of the BioPhorum podcast, where we delve into the critical topic of cybersecurity in the biomanufacturing industry, which is now woven into the overall vision for digital maturity expressed in the Digital Plant Maturity Model. Hosted by Tim Horton, this episode features expert guests Anderson Goebel from Merck and Tom House from Rockwell Automation, who share their practical experiences and strategies for enhancing cybersecurity in their organizations. Key topics discussed include:The importance of IT and OT convergence for digital maturity and cybersecurity.Practical steps for implementing cybersecurity frameworks and achieving consistency across organizations.The impact of regulatory changes and validation challenges on cybersecurity practices.The role of tabletop exercises in improving collaboration and risk management.Don't miss this opportunity to gain valuable insights and learn from industry leaders. Check out the resources mentioned in the podcast:Digital plant maturity model v3IT vs OTTabletop exercise to improve incident response
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Managing data as a product
Our AI-generated podcast explores the transformative concept of managing data as a product, and discusses how adopting a data product mindset can revolutionize digital transformation in the pharmaceutical industry. Key takeaways include: Understanding the importance of clear data ownership roles Exploring different data architecture strategies like data mesh and data fabric Realizing that a data product is more than just a dataset and what that means for ownership roles Visualizing the lifecycle of a data product and the responsibilities involved.
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The DISCO playbook
This AI-generated conversation reviews the recently-published Playbook for digital integration of sponsor and contract organizations (DISCO). With the rise of external manufacturing in the pharmaceutical supply chain, managing numerous partners has become complex. Digital transformation is essential for visibility and flexibility. Practitioners have shared their experiences and practical solutions for moving to digital partnerships. The podcast covers challenges, digital integration, stages of developing partnerships, and crafting collaboration agreements - with a big emphasis on the human factors.Also available is a public webinar 22 Jan 2025 by eight of the authors
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Navigating Drug-Device Co-Development and Biocompatibility: Insights for success
In this episode, Soroosh and Soumen delve into the critical aspects of drug-device co-development, emphasizing the importance of early collaboration between teams to enhance patient safety and streamline processes. They discuss the vital role of biocompatibility testing, highlighting the need for early implementation to avoid delays and ensure regulatory compliance. The conversation also covers the complexities of regulatory challenges, including the variability in review processes across agencies like the FDA and EMA. Finally, Soumen introduces the concept of leveraging platform technology for biocompatibility testing, offering strategies for efficient integration in development programs. Tune in for valuable insights that can help navigate the intricacies of drug-device collaboration!
BioPhorum Connect is a podcast series that talks to thought leaders and subject matter experts about the latest trends and challenges facing the biopharmaceutical industry. From digitization, knowledge management, raw materials, supply chain, sustainability, and everything in between, listen now and get the low down.
Ireland