05.16.22
Berkshire Sterile Manufacturing (BSM), a sterile filling contract manufacturer located in Lee, MA, has recently added formulation, lyophilization, and method development capabilities to its drug development services.
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.
“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.
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.
“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.
