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| Join Bioprocess Online’s Tyler Menichiello on April 28 at 11 AM ET for an interactive panel discussion examining how regulatory lag, evolving biocompatibility standards, and the complexity of converting legacy systems slow the uptake of innovative single-use materials in biomanufacturing. Registration is free thanks to event sponsor Cytiva. |
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By Tim Sandle, Ph.D. | A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation. | |
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By Kishore Hotha, Ph.D., Dr. Hotha’s Life Sciences LLC | For those involved in pharma outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8. | |
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With Takeshi Ono, Daiichi Sankyo; and Masaru Fujita, Kyowa Kirin | Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear, consistent criteria. Here is how regulator positions are evolving. | |
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A conversation with Franck Bure, Genentech/Roche | Regulatory scrutiny now demands data-driven evidence over simple risk assessments to meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers. | |
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