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08.13.21 -- No, Biologics Are Not Natural Monopolies

08.13.21 -- No, Biologics Are Not Natural Monopolies
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.

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04.15.21 -- An Introduction To Trending In Environmental Monitoring Programs

04.15.21 An Introduction To Trending In Environmental Monitoring Programs

In this
Consumer Reports-style analysis, ISR presents data on 383 service encounters from 123 respondents who have been involved in outsourced drug product projects in the past 18 months. This report will help biopharmaceutical companies make more informed CMO decisions and CMOs optimize operational and marketing strategies. You can access a free preview here.
Featured Editorial
By Crystal M. Booth, PSC Biotech
Trending environmental monitoring (EM) data are a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, I look first at the regulations and guidelines around EM. ....

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03.16.21 -- 11 Critical Steps To Manage Solvents During API Manufacturing

03.16.21 11 Critical Steps To Manage Solvents During API Manufacturing

Gibco premium peptones are specifically created for bioprocessing to achieve a higher level of quality and limited variability. The result can improve performance and speed-to-market for your next monoclonal antibody (mAb) blockbuster. Considering peptones but unsure where to start? Learn about smaller-sized Starter Paks the easiest way to assess the variety of peptones offered and to identify the ideal supplements for your process.
Featured Editorial
By Grant Mordue, Pro-Active GMP Consulting Ltd.
To reduce costs and provide flexibility, manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This article explores the risks and 11 mitigation options available to API manufacturers. ....

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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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12.10.20 -- Bioprocessing Year In Review: 11 Key Trends Accelerated By COVID-19

12.10.20 Bioprocessing Year In Review: 11 Key Trends Accelerated By COVID-19

Nanoform Finland Plc (Nanoform), an innovative nanoparticle medicine enabling company, will be featured in an upcoming Advancements episode broadcasting via CNBC on Saturday, December 12, at 2:30 p.m. (ET). Viewers will learn how Nanoform’s award-winning CESS® nanoparticle engineering technology can potentially double the number of drug candidates progressing into clinic.
Featured Editorial
By Ronald A. Rader and Eric S. Langer, BioPlan Associates, Inc.
Despite the morbidity, deaths, and terrible societal disruptions associated with the COVID-19 pandemic, 2020 will have created something of a positive outcome for the bioprocessing sector.
By James Akers, James Agalloco, and Russell Madsen ....

Enrique Carredano , Kelly Flook , Malcolm Mclaughlin , Orjana Terova , Christine Banaszek , Sylvia Tsengouras , Josh Russell , Jeff Phillips , Janice Abel , Kara Faford , Josine Wilmer , Fred Hines , Patrick Guertin , Bernt Dietmar Schober , Isabelle Lafosse , Charles Ross , Alejandro Becerra , Johnj Li , Andreas Stolle , Seeq Corporation , Alconox Inc , Case Study West Pharmaceutical Services Inc , Automated Systems Of Tacoma Inc , Pharma Services , Son Company , Webinar Dec Group ,