Berkshire Sterile Manufacturing (BSM), a sterile-filling contract manufacturer located in Lee, MA, has 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 Andrea Wagner, PhD, CTO and co-founder. “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. The company will perform formulation development using materials and equipment representative of future GMP manufacturing, according to Wagner, who points out that 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 (lyo) formulation, lyo cycles based on thermal properties, and scaleup of the lyo process when the client moves on in their clinical trials or to commercialization, continued Wagner.
These new service offerings will reduce timelines, lower risk for technology transfers, and provide high-level expertise for scaleup and cGMP activities, explained Xufeng Sun, PhD, vp of formulation and technology transfer.
“We can work with both simple and complex formulations, and we are excited to solve unique formulation challenges,” continued 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 officials added that the firm has also expanded the lab to include method development. 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, according to Shawn Kinney, PhD, CEO, and company co-founder.
“Development is a service that many clients have asked us to do since we began our aseptic filling services in 2016,” he said. “Now that we have the staff, equipment, and facilities to support these new offerings, we expect it to complement our other services nicely.”