|Articles|September 1, 2003

BioPharm International

  • BioPharm International-09-01-2003
  • Volume 16
  • Issue 9

Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) Areas

The complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.
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Articles in this issue

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A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media Supplement

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Inside Washington: Reimport Battle Complicates Anticounterfeiting Campaign

over 22 years ago

Integrating CMC Document Preparation into the Development Process for Vaccine INDs

over 22 years ago

Large-Scale Manufacturing of Plasmid DNA for Gene Therapy and DNA Vaccination -- Part 2: Toward an RNase-Free Downstream Process ? A Review

over 22 years ago

Sterile Fill Facilities: Problems and Resolutions

over 22 years ago

CROs Hope for Second Half Research Burst

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