This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of continuous processing technologies for the manufacture of biopharmaceutical products.
bioprocess; continuous manufacturing
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.
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: 005
Ballot: E55 (22-05)
Status: Ballot Item Approved
Item: 003
Ballot: E55 (22-02)
Status: Will Reballot Item