Work Item
ASTM WK64991

New Practice for Stability of Early Phase Protein Products

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

stability study

Rationale

This standard would be useful to simplify the initial assessment of stability for an IND submission.

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: 08-31-2018

Technical Contact: Robert Steininger II

Item: 003

Ballot: E55.04 (19-01)

Status: Will Reballot Item

Item: 002

Ballot: E55.04 (19-03)

Status: Will Reballot Item

Item: 001

Ballot: E55 (21-01)

Status: Negative Votes Need Resolution