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High-Loaded Dosage Forms Novel Platform Expands Dispersion Utility
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09 14 21 -- Best Practices For Raw Material Supplier Change Notifications
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EPR Podcast Episode 2 – Bioavailability Dr Deanna Mudie, Lonza
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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 likelihood rating approa
12.15.20 Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products
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 be $40, whereas a 45-minute phone interview may be $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial
By Ruijin Song and Andrew Walsh, Center for Pharmaceutical Cleaning Innovation (CPCI)
A simple time-to-clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.