Work Item
ASTM WK65428
New Guide for the Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
1. Scope
The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, specifications, and performance standards for the manufacture of pharmaceutical and biopharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops, and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.
Keywords
bioprocess; continuous manufacturing
Rationale
Within Drug Substance production the emphasis may be more on biological behavior in the upstream production phase of the process (bioreactor) and more on biochemical and physical interactions in the downstream recovery and purification part of the process. A bioprocess consists of multiple connected unit operations, not all of which are necessarily operating in a continuous mode.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 10-17-2018
Technical Contact: Duncan Low
Item: 001
Ballot: E55.04 (20-01)
Status: Will Reballot Item
Item: 001
Ballot: E55 (21-04)
Status: Will Reballot Item
Item: 003
Ballot: E55 (22-02)
Status: Negative Votes Need Resolution