Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO), expects to double their lyophilization capacity for their fully automated, isolator-based filling line to meet new demand. A second lyophilizer will be added to the line to increase capacity to 70,000 10R vials per run.

“We are seeing an increase in demand for lyophilization,” said vice president of manufacturing, Tyler Rush. “In order to accommodate our clients’ growing needs and to cater to their patient population, we have made the decision to expand our capacity.”

The demand for lyophilized drug products is experiencing a notable surge, yet the contract fill finish industry is currently facing a shortage of adequate lyophilization capabilities, support, and capacity. BSM took proactive measures by incorporating a second lyophilizer into their state-of-the-art filling line, ensuring seamless accommodation and addressing this critical need for its clients.

“The additional lyophilizer will be able to pull resources from the infrastructure we added in 2021, and it will have the same automated loading and unloading systems as our current lyophilizer taking into account lessons learned,” said BSM’s associate director of engineering, Ron Trefzger. “During the design and construction of the line, we incorporated plans for this addition to ensure it could be added seamlessly and uphold the same quality standards and sterility assurance levels that our clients have come to expect from us.”

BSM’s current lyophilization capacity on the line is 35,000 10R vials and the addition of the redundant lyophilizer will double that capacity to 70,000 10R vials. The company expects to lyophilize GMP lots on the new lyophilizer by Q4 of 2025.