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 biopharmaceutical industry.
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 emphasizing 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.