The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-01-2003
Volume 2003 Supplement
Issue 2

Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.

External Link - article-66625.pdf

Articles in this issue
The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?
FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing
Training for Aseptic Processing Environments
Recent Videos
Behind the Headlines episode 6
Behind the Headlines episode 5
Buy, Sell, Hold: Cell and Gene Therapy
Buy, Sell, Hold: Cell and Gene Therapy
Related Content
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Alentis Therapeutics to Advance Anti-Claudin-1 ADCs to Treat Solid Tumors on $181.4 Million Financing

Feliza Mirasol
November 19th 2024
Article

Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Newly Opened Innovation Center in New Jersey Gives Avantor Advantage in Solving Life Sciences Challenges

Feliza Mirasol
November 15th 2024
Article

Avantor's newly launched expanded Innovation Center in Bridgewater, NJ, is designed for integrated workflows and features purpose-built collaboration spaces.

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

March 26th 2024
Podcast

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Merck and Ginkgo Bioworks’ Collaboration to Improve Biologics Manufacturing Has Reached Its First Milestone

Feliza Mirasol
November 13th 2024
Article

Under an ongoing partnership with Merck, known as MSD outside of the United States and Canada, Ginkgo Bioworks has achieved the first milestone in a project aimed at improving biologics production.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

TrakCel’s OCELLOS Platform Selected to Support Treatment Management of Five Upcoming Cell Therapy Products

Feliza Mirasol
November 13th 2024
Article

Manufacturers of five autologous or matched allogenic cell therapy products have selected TrakCel's IT platform, OCELLOS, to orchestrate the administration of these therapies, which are approved or expected to be approved in 2024.