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09.17.21 -- An Analysis Of ICH Draft Guidance Q13: Continuous Manufacturing Of Drug Substance And Drug Products

09.17.21 -- An Analysis Of ICH Draft Guidance Q13: Continuous Manufacturing Of Drug Substance And Drug Products
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05.06.21 -- Why Adjusted Risk Likelihood Should Displace The Risk Priority Number

05.06.21 Why Adjusted Risk Likelihood Should Displace The Risk Priority Number

Catching up to the paradigm shift in optimizing, scaling up, and manufacturing plasmids is crucial for clinical to commercial program success for gene therapies and vaccines. With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. Join Aji Bio-Pharma to learn about methodologies to ensure effective production and increase the likelihood of market success.
Featured Editorial
By Mark F. Witcher, Ph.D., Exyte US
While the risk priority number (RPN) primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk lik ....

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12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends

12.17.20 FDA FY2020 Drug Inspection Observations And Trends

ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may pay $40, whereas a 45-minute phone interview may pay $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial

This article presents the FDA s most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement. ....

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