As Berkshire Sterile Manufacturing (BSM) approaches its five-year anniversary this month, it will have reached over 110 employees. The state-of-the-art fill/finish manufacturing company provides formulation and sterile filling services to biotechnology companies. Their services have been used to fill injectable medications for pre-clinical to clinical trials for orphan drugs, vaccinations, and cancer therapies among several other treatments. BSM also offers expertise and specialization in analytical development and stability services for biotech and pharmaceutical industries.
Four months before its fifth birthday, BSM hired its 100th employee. The company’s rapid success is in part due to its innovative isolator-based design. All drug filling activities occur inside sterilized isolators with state-of-the-art fillers to ensure all its products are sterile and safe for injection. Historically, isolators were not used in small batch sterile manufacturing and thereby medications were filled inside cleanrooms requiring manufacturing staff to sterile gown. BSM revolutionized sterile drug manufacturing by involving isolators and flexible filler systems so all product exposure could occur in a sterilized environment, dramatically reducing the possibility of human contamination. This process is also more comfortable for manufacturing staff as they do not have to gown to the extent that their predecessors had to, and the amount of waste and energy used in the process is significantly reduced, making this filling method far more environmentally friendly.
Berkshire Sterile Manufacturing CEO, Shawn Kinney, credits this technology in combination with the hardworking staff as the reason that Berkshire Sterile’s services are in high demand:
“We care about creating a high quality and controlled product so that our clients will only need to concern themselves with advancing their medication through clinical trials.”
The company is also excited to announce its plan to add a third isolator-based fill line. The line is currently scheduled to be operational by 2020 and will allow Berkshire Sterile to expand its services. The company will later be able to manufacture large quantities of sterile products including lyophilized vials and will demand 60 new positions.
Shawn Kinney commented, “By the end of 2017 we had 50 employees. We have already doubled that number and we will continue to hire more talent.”