Berkshire Sterile to Offer Formulation, Lyophilization & Method Development Services

Berkshire Sterile Manufacturing (BSM) MA, has recently added formulation, lyophilization, and method development capabilities to complement their clients’ drug 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,” said BSM CTO and Co-founder, Dr. Andrea Wagner. “We expanded our team to add these development activities to better assist our clients and provide new offerings for future clients as well.  We can lead our clients into production faster and with a higher confidence of success by performing their development in house.”

BSM will now offer first-in-human formulation development, supply 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 allow them a head start in their analytical method feasibility, evaluation, and development.

For clients looking to enhance their drug product stability through freeze-drying, BSM can develop their lyophilization formulation, lyo cycles based on thermal properties, and scale-up the lyo process when the client moves on in their clinical trials or to commercialization.  BSM offers the unique ability to handle the development through commercialization to finalize their clients’ processes for a successful commercial presentation.

These new service offerings will reduce timelines, lower risk for technology transfers, and provide high-level expertise for scale-up and cGMP activities. “We can work with both simple and complex formulations, and we are excited to solve unique formulation challenges,” said BSM Vice President of Formulation and Technology Transfer, Dr. Xufeng Sun. “Our mission is to become a partner to our clients and to move their product forward quickly with a higher degree of success to benefit patients worldwide.”

BSM has also expanded their capabilities in the lab to include method development. BSM will design methods to obtain the desired analytical measurements with the appropriate characteristics. During method development the accuracy, precision, linearity, and specificity will be assessed as well as system suitability requirements. The BSM team will provide a development report detailing the laboratory work that was performed and expectations for performance of the method. In addition, a draft test method will also be provided.

Following method development, BSM can perform method qualification or validation, as appropriate for the development phase of the product.

“Development is a service that many clients have asked us to do since we began our aseptic filling services in 2016,” said BSM CEO and Co-founder, Dr. Shawn Kinney. “Now we have the staff, equipment and facilities to support these new offerings, and we expect it to complement our other services nicely.”

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. Analytical services, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, visit https://berkshiresterilemanufacturing.com/.