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Purdue to Host Drug Manufacturing Standards Meeting

August 27, 2018

3 Min Read
Purdue to Host Drug Manufacturing Standards Meeting

Purdue University’s Advanced Lyophilization Technology Consortium (LyoHUB) has been selected to host and co-sponsor the ASTM E55 Committee on Manufacture of Pharmaceutical and Biopharmaceutical Products semiannual conference.

LyoHUB will present the 2018 ASTM E55 Workshop on Pharmaceutical Lyophilization, also known as freeze-drying, on Oct. 23, at the Indiana Manufacturing Institute, located in the Purdue Research Park. Then, the E55 committee meetings will take place Oct. 24-25.

“LyoHUB has become a connecting point for people interested in lyophilization,” said Elizabeth Topp, LyoHUB co-director and professor in Purdue’s Department of Industrial and Physical Pharmacy. “Industry and academia come together through LyoHUB, with a balance of industry and academic voices.”

Pharmaceutical lyophilization refers to the freeze-drying process in pharmaceutical manufacturing that improves the stability and shelf-life of compounds. This essential technology originally enhanced medicinal preservation of antibiotics and blood plasma, making new treatments possible, such as room-temperature stored live virus vaccines. Today, lyophilization is essential for manufacturing a variety of critical pharmaceutical drugs and diagnostic reagents.

“Of the last 10 years’ worth of FDA-approved biopharmaceuticals, 40 percent were manufactured in a lyophilized dosage form,” said Alina Alexeenko, LyoHUB co-director and a Purdue professor in the School of Aeronautics and Astronautics. “Lyophilization is the least known of the most important technologies in the 20th century, because it had a major role in the eradication of the smallpox epidemic and is now enabling many life-saving medicines.”

LyoHUB, a Purdue-based consortium composed of academics and industry professionals, was co-founded by Alexeenko and Topp. The group’s primary mission is advancing lyophilization technology and production value through industry-oriented, academic-supported feedback.

Lyophilization is among the most time-consuming and expensive unit operations in pharmaceutical manufacturing, with an energy efficiency of less than 5 percent, batch mode operation, open-loop processing and lack of in-line quality monitoring. The regulatory process also can discourage companies from introducing new technologies to make efficiency and time saving improvements to their process.

ASTM seeks to change this situation, and others like it, by developing science-based consensus standards in manufacturing and product quality for pharmaceutical manufacturing. The ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, co-sponsor of the October conference with LyoHUB, brings together equipment manufacturers, end-users of the equipment and academics from around the globe to work on consensus standards.

Alexeenko and Topp said they hope by hosting the conference and workshop, LyoHUB can inspire discussion within the E55 Committee about lyophilization consensus standards and the advancement of the technology.

“LyoHUB is a very active consortium,” said Jennifer Gray, LyoHUB’s communications and event coordinator. “When we developed the lyophilization technology road map, it was impressive to witness the active engagement from a large, diverse group from industry and academia working together to tackle these complex issues.”

To attend the free conference, interested individuals need to register here.

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