Research Foundation News

August 22, 2018

Purdue to host pharmaceutical manufacturing standards meeting

WEST LAFAYETTE, Ind – 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.

Event Details

  • Workshop and meeting held at the Indiana Manufacturing Institute, 3975 N. 100 W, West Lafayette.
  • Oct. 23 — Purdue LyoHUB hosts 2018 ASTM E55 Workshop on Pharmaceutical Lyophilization. For LyoHUB information, contact Jennifer Gray at gray160@purdue.edu.
  • Oct. 24-25 — Standards development meetings of Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products. For ASTM E55 Committee info, contact Travis Murdock, ASTM staff manager, at tmurdock@astm.org.
  • Register for the event at http://www.astm.org/E55WorkshopOct2018.

About LyoHUB

The goal of the Advanced Lyophilization Technology Consortium (LyoHUB) is to advance the science and technology of freeze-drying/lyophilization. The consortium was established by a 2015 grant from the National Institute of Standards and Technology (NIST) with a mandate to develop a lyophilization technology road map and cultivate a group to make needed advancements in this area. LyoHUB has been listening to industry needs and engaging academia to assist in approaching complex freeze-dry technology issues. LyoHUB’s members include companies in the pharmaceutical sector, equipment and excipient manufacturers, software companies and university researchers, who combine their expertise and resources to accomplish common goals. Immediate objectives are: (i) to identify and disseminate best practices for lyophilization equipment performance, testing and validation and (ii) to conduct applied research to advance lyophilization processes and products. For more information about LyoHUB, visit their website at www.lyohub.org

About Purdue Research Park

The Purdue Research Park is managed by the Purdue Research Foundation and is the largest university-affiliated business incubation complex in the country. The Purdue Research Park manages the Purdue Technology Centers in five sites across the state of Indiana with locations in West Lafayette, Indianapolis, Merrillville and New Albany. The more than 260 companies located in the park network employ about 5,000 people. In 2016, the Association of Public and Land-grant Universities co-named the Purdue Research Park a top recipient for an Innovation and Economic Prosperity Universities Designation for its work in entrepreneurship. For more information about leasing space in the Purdue Research Park, contact 765-588-3470 or click Purdue Research Park.

Writer: Kelsey Henry, 765-588-3342, kehenry@prf.org

Purdue Research Foundation Contact: Tom Coyne, 765-558-1044, tjcoyne@prf.org

Sources: Alina Alexeenko, alexeenk@purdue.edu

Elizabeth Topp, topp@purdue.edu

Jennifer Gray, gray160@purdue.edu


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