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| Webinar: Biologics Tech Transfer & Validation at Scale: A Better Path to GMP | Tech transfer and validation can make or break biologics scale-up. Join Avid Bioservices to explore where risk typically emerges across site transfer, PPQ, and continued verification, and how to stay ahead of it. Learn how to align teams, transfer process knowledge effectively, reduce variability, and support smoother, more compliant progression from clinical to commercial manufacturing. Click here to learn more. |
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By Better Biopharma | In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. | |
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| A Smooth Transition To USP <382> With Established Expertise | Q&A | BD Medical - Pharmaceutical Systems | A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety. |
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| Developing Robust mRNA Processes In A cGMP Environment | Poster | By Clemens Jakobi, Michal Domański, and Telmo Graça, Lonza | Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment. |
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| Trends In Mid-Size Scale Up Strategies | Video | LOTTE Biologics | A development leader highlights supply‑chain resilience, cost‑efficient large‑scale manufacturing, proven tech‑transfer success, and long‑term commitment to supporting clients through reliable scale‑up. |
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| Evaluating The Impact Of In-House Testing Strategies | Article | By Kaden Moore, August Bioservices | Rapid analytical testing turnaround is essential to maintaining development timelines, meeting clinical milestones, and in commercial manufacturing, providing reliable drug supply to patients. |
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| What Makes A Cell Bank 'GMP-Ready'? | Article | Abzena | A GMP‑ready cell bank requires controlled stability, sterility, genetic integrity, and complete documentation to ensure consistent, safe biologic production and meet regulatory expectations. |
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| Tailoring Viral Clearance Study Design | White Paper | Minaris | Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes. |
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