Standardization News

A new ASTM International subcommittee will focus on the process of lyophilization, often referred to as freeze-drying, in the pharmaceutical industry. The group (E55.05) will bepart of the committee on pharmaceutical and biopharmaceutical products (E55).

The Advanced Lyophilization Technology Hub (LyoHub), a group of manufacturers, researchers, and others in the pharmaceutical and food processing industry, proposed the formation of the new subcommittee. The group aims to build on best practices related to lyophilization process instrumentation, equipment qualification, and scale-up.

LyoHub’s interest, combined with recent overall interest reflected in survey results within the committee, led to the approval of the new subcommittee.

The subcommittee will develop practices and guides relevant to lyophilization of parenterals and other pharmaceutical and biological products. Standards developed by the subcommittee could include aspects of process and equipment design, operation and qualification, quality assessment, process understanding and control.

Arnab Ganguly, technology manager at IMA Life, has been appointed chairman of the lyophilization subcommittee. All interested parties are encouraged to join in these standards developing activities.

As background, in 2015, the U.S. National Institute of Standards and Technology (NIST) awarded LyoHub an Advanced Manufacturing Technology Consortia grant. During a meeting at NIST, representatives of the U.S. Food and Drug Administration advised LyoHub to consider using their best practices as a basis for creating consensus standards through the ASTM International process.