Berkshire Sterile Manufacturing (BSM), a sterile filling contract manufacturer located in Lee, MA, has recently added formulation, lyophilization, and method development capabilities to complement their clients’ drug productions.
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.
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.
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. Analytical services, stability studies, lyophilization development, formulation development, and method development are also offered.
