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03.02.21 -- FDA's COVID-19 PREPP Initiative Summary Report -- Keys For Manufacturers


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.  ....

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Looking Back And Moving Forward In The Fight Against SARS-CoV-2


Looking Back And Moving Forward In The Fight Against SARS-CoV-2
By Eric S. Langer, Managing Partner, BioPlan Associates, Inc., Christopher Murphy, Vice President/General Manager, Viral Vector/Pharma Services, Thermo Fisher Scientific, Brandon Pence, Vice President/General Manager, Purification and Pharma Analytics, Thermo Fisher Scientific, Chris Williams, Vice President/General Manager, Single-Use Technologies, Thermo Fisher Scientific, Kate Torchilin, Vice President/General Manager, Cell Culture and Cell Therapy, Thermo Fisher Scientific
The unprecedented global crisis brought on by SARS-CoV-2 has affected all aspects of life and business. This includes the pharmaceutical industry, where existing trends that were driving incremental changes prior to the pandemic have been accelerated to meet the demand for SARS-CoV-2 vaccine production and delivery. A recent study by BioPlan Associates takes a closer look at the impact of SARS-CoV-2 on bioprocessing, specifically the nea ....

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02.25.21 -- Developing Future Delivery Models For ATMPs


02.25.21 Developing Future Delivery Models For ATMPs
 
 
Seeq is hosting a live virtual event featuring pharmaceuticals and life sciences experts from Eli Lilly, Lonza, Amgen, and more on March 10, 2021. Mark your calendars and register to hear how other companies in your industry are using advanced analytics technology to turn their data into insights, drive process improvement, and increase profitability.
 
This is a live event, and the presentations will not be accessible afterward. Save your spot today spaces are limited!
Featured Editorial
By Erich H. Bozenhardt and Herman F. Bozenhardt
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial ma ....

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