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By Amanda Mack and Alicja Fiedorowicz, Dark Horse Consulting Group | This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29. |
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| Annex 21 – Are We On Track, And Is There An Impact? | Article | By Geraldine Carr-Mulry, CAI | What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply? |
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| Environmental Monitoring vs. Good Aseptic Technique | Webinar | Particle Measuring Systems | Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems. |
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FOCUS ON ANALYTICS & QUALITY |
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By Bioprocess Online Live | Astellas Gene Therapies director of technical development Joshua Zibit surveys the landscape of new and developing tools and technologies available to bioprocess professionals. |
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| Digitalizing Biopharma Manufacturing Step-By-Step: Part I | Article | By Shawn Opatka, Honeywell Process Solutions | Digital transformation offers tangible advantages in terms of time, cost, and efficiency. Learn about a popular way to digitalize high-risk environments that can easily be achieved in biopharma manufacturing. |
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ANALYTICS & QUALITY SOLUTIONS |
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