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09 16 21 -- How To Find (and Manage) Biotech Consultants
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
07 20 21 -- Qualification Considerations For A Factory-in-a-Box
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
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 discusses tools and b
03.02.21 FDA s COVID-19 PREPP Initiative Summary Report Keys For Manufacturers
This report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 22 performance attributes specific to outsourced drug substance manufacturing. ISR presents data on 358 service encounters from 123 respondents who have been involved in outsourced small molecule API projects in the past 18 months. Preview.
Featured Editorial
Published in January 2021, the FDA s
COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic.
01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies
This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here.
Featured Editorial
By Herman F. Bozenhardt and Erich H. Bozenhardt
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality.
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