New biopharma standard to provide guidance for continuous manufacturing
ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee (E55) has approved a new standard that will help advance the use of continuous manufacturing (CM) technologies in the biopharma industry.
Key highlights:
- ASTM's E55 committee have approved a new biopharma standard to progress the use of continuous manufacturing technologies.
- ASTM hopes the new standard will provide guidance on meeting regulatory and quality expectations to accelerate development and approval of novel therapies.
In a CM process, individual unit operations are integrated into a connected flow which provides multiple efficiencies in terms of scale and productivity.
“Pharmaceutical manufacturers, governments, and regulatory agencies are emphasising the importance of advancing CM technologies as a way of lowering costs, improving flexibility and response times to changes in demand, and advancing quality,” says ASTM member Duncan Low.
“The new standard will provide guidance on how to meet expectations for regulatory acceptance and quality standards as a way of accelerating development and approval of novel therapies for medical conditions.”
Low notes that a CM standard for orally ingestible small molecule tablets has been available for a while. The new standard (soon to be published as E3326) will provide additional considerations for biological molecules because of their inherent complexity and different processing requirements, such as avoiding temperature extremes and the need for aseptic conditions.
ASTM welcomes participation in the development of its standards.