A proposed ASTM International standard will help advance the concept of lyophilization (freeze-drying) as it is used in the pharmaceutical and biotechnology industries. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) is developing the proposed standard.
“The proposed standard will promote a deeper understanding of the science and engineering of pharmaceutical engineering, which is a fundamental component of the quality by design paradigm,” says ASTM International member Arnab Ganguly. “As a result, it will help the manufacturers to assure the consistent quality, safety, and efficacy of the drug product and allow the researchers to develop the lyophilization processes following the highest industry standards.”
According to Ganguly, the proposed standard (WK80172) will help to consistently develop approaches to freeze-drying process improvement, product monitoring, and process understanding to manufacture safe, effective, and high-quality products.
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