Work Item
ASTM WK65428

New Guide for the Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

1. Scope

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.

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.

Details

Developed by Subcommittee: E55.04

Committee: E55

Staff Manager: Travis Murdock

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: 005

Ballot: E55 (22-05)

Status: Ballot Item Approved

Item: 003

Ballot: E55 (22-02)

Status: Will Reballot Item