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PROJECTS/PROGRAMS

WG4 Bioprocessing

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Summary

Within bioprocessing, Working Group 4 has currently identified standardization needs in four major technology spaces: 1) component materials control; 2) bioreactor processes; 3) collection, separation, purification and formulation; and 4) handling, transportation & storage. Each category of materials/technology space may affect many current and future applications.

Click here for the most current TC276 Programme

Description

Standard(s) Under Development:

  • ISO/AWI TS 20399-1: Raw materials control for bioprocessing -- Part 1: General definitions and requirements for quality control
  • ISO/AWI TS 20399-2: Raw materials control for bioprocessing -- Part 2: Best practice guide for supplies
  • ISO/AWI TS 20399-3: Raw materials control for bioprocessing -- Part 3: Best practice guide for developers
  • ISO/AWI 21973: Biotechnology -- General requirements to establish specification of cell transportation
  • Equipment Selection for Cell Therapy Processing

US TAG WG4 Convenor:  Jiwen.Zhang [at] ge.com (Jiwen Zhang), PhD, GE Healthcare  
TAG Administrator:  Clare Allocca

Bioscience, Biopharmaceuticals, Biomanufacturing, Metrology and Standards
Created January 20, 2015, Updated March 26, 2025
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