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04.22.21 -- Tools And Best Practices For Trending Environmental Monitoring Data

04.22.21 Tools And Best Practices For Trending Environmental Monitoring Data

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 Crystal M. Booth, PSC Biotech
Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article ....

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12.16.20 -- FDA's Office Of Minority Health And Health Equity Addresses Patient Diversity

12.16.20 FDA s Office Of Minority Health And Health Equity Addresses Patient Diversity

AVROBIO president and CEO Geoff MacKay tells
Business of Biotech about the technology his company is using to drive at-scale gene therapy production for lysosomal disorders and how they overcame a major manufacturing investment that didn t quite work as planned. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
The diversity of patients participating in clinical trials continues to be a problem in drug development. As sponsors and sites attempt to address the problem, regulators are also doing their best to address the issue. One person deeply involved in this issue is Rear Admiral Richardae Araojo, the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at the FDA. ....

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