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.

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: 003

Ballot: E55 (22-02)

Status: Negative Votes Need Resolution