Berkshire Sterile Manufacturing adds new IMA lyophilizer to support development work

Globe Newswire

Berkshire Sterile Manufacturing (BSM) purchased a new IMA lab-scale lyophilizer to support their lyophilization development studies – a service that was added in Q1 2022. This acquisition is the company’s fourth lyophilizer, and second lab-scale model. BSM has a clinical-scale lyo affixed to their existing semi-automated, 100% isolator-based filling line and they have a commercial-scale lyo that was recently installed in Q4 2021 as part of their new, fully automated, isolator-based filling line that is currently undergoing validation. The new line will be available for cGMP compliant manufacturing at the end of Q2 2022, and it will expand their lyophilization capacity tenfold.

“We can lyophilize approximately 3,000 10R vials in our clinical scale lyophilizer. The commercial scale lyophilizer we are installing will be able to process about 30,000 10R vials,” stated Chief Technical Officer and cofounder, Dr. Andrea Wagner.

BSM recently added new development capabilities in lyophilization, formulation, and analytical methods to support their early-phase clients that are looking to establish their fill finish process. To support their lyophilization development work, the company purchased an Epsilon 2-10D LSCplus lyophilizer from IMA with microbalance capability.

“With this new lyophilizer, we can now perform more studies and gather additional data to produce a cycle with greater confidence at a significantly lower cost to the client,” said Vice President of Formulation and Technology Transfer, Dr. Xufeng Sun.

Previously, all lyophilization development studies were performed at IMA and transferred through engineering runs on the company’s clinical scale lyophilizer.  The lead time for outsourced development can be greater than 6 months. Implementing this capability in-house greatly reduces the lead-times to enter clinical production.

BSM can help their clients develop or optimize their lyophilization cycle. Once a cycle is established, the process is transitioned to their clinical or commercial scale lyophilizer for drug product manufacturing.

“There is a significant advantage to performing development work at your fill finish CMO,” stated Manager of Process Engineering, Dr. Sarandeep Malhi, “your CMO will have a deep understanding of your process, leading to a much more successful fill finish process.”

Berkshire Sterile Manufacturing already has a few lyophilization development programs in process since offering the capability in February of 2022.

About Berkshire Sterile Manufacturing

Berkshire Sterile is a state-of-the-art fill/finish contract manufacturer which specializes in sterile filling of syringes, vials and cartridges for the biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, lyophilization of vials, dual chamber liquid/liquid and liquid/lyo all within an isolator. Lyophilization development, formulation development, and method development are also offered. Please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact Berkshire Sterile at info@berkshiresterile.com for more information.

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