Lee, MA, 09 Feb. 12, 2022 (GLOBE NEWSWIRE) — Berkshire Sterile Manufacturing (BSM), a sterile filling contract manufacturer located in Lee, MA, recently added formulation, lyophilization and method development capabilities to supplement its customers’ medication productions. .
“We are very experienced in complex formulations and unique filling programs. However, we have found that many companies we work with do not have their formulations fully developed or optimized,” commented BSM CTO and co-founder Dr. Andrea Wagner, “We have expanded our team to add these development activities to to better support our customers and provide new offers for future customers as well. We can get our customers to production faster and with greater confidence of success by doing their development in-house. »
BSM will now offer first-in-human formulation development, provide material for preclinical studies, and conduct research-level stability studies. BSM will also offer formulation optimization, process development, process optimization and scale-up studies. They will perform formulation development using materials and equipment representative of future GMP manufacturing. This information is shared with BSM’s quality control group to give them a head start in the feasibility, evaluation and development of their analytical method.
For customers looking to improve the stability of their drug product through lyophilization, BSM can develop their lyophilization formulation, lyophilization cycles based on thermal properties, and expand the lyophilization process as the customer moves to their clinical trials or to marketing. BSM offers the unique ability to manage development through to market to finalize their clients’ processes for a successful business presentation.
These new service offerings will reduce lead times, reduce technology transfer risks and provide high-level expertise for scaling and cGMP activities. “We can work with both simple and complex formulations, and we are happy to solve unique formulation challenges,” commented BSM’s Vice President of Formulation and Technology Transfer, Dr. Xufeng Sun. “Our mission is to become a partner to our customers and rapidly advance their product with a higher degree of success for the benefit of patients around the world.”
BSM has also expanded its laboratory capabilities to include method development. BSM will design methods to obtain the desired analytical measurements with the appropriate characteristics. During method development, accuracy, precision, linearity and specificity will be assessed along with system suitability requirements. The BSM team will provide a development report detailing the laboratory work that has been carried out and the expectations for the performance of the method. In addition, a draft test method will also be provided.
After method development, BSM can perform method qualification or validation, depending on the needs of the product development phase.
“Development is a service that many customers have asked us to do since we started our aseptic filling services in 2016,” said BSM CEO and co-founder Dr. Shawn Kinney, “we now have the staff, the equipment and facilities to support these new offerings, and we expect it to complement our other services well.”
About Berkshire Sterile Manufacturing
Berkshire Sterile is a state-of-the-art fill/finish contract manufacturer specializing in the sterile filling of syringes, vials and cartridges for the biotechnology and pharmaceutical industries. BSM also offers terminal vapor sterilization of syringes, specialized filling, lyophilization of vials, liquid/liquid and liquid/lyo dual chamber, all in one isolator. Analytical services, stability studies, lyophilization development, formulation development and method development are also offered. Please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact us at [email protected] for more information.
Development of methodsDevelopment of formulations
Andrea Wagner Berkshire Sterile Products Manufacturing 413-243-0330 [email protected]
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