Lee, MA, Sept. 13, 2022 (GLOBE NEWSWIRE) — Following its recent expansion into lyo formulation, method and development, Berkshire Sterile Manufacturing (BSM) now offers two new services to assist customers in their efforts to R&D as they move towards development and clinical trials. “We’ve had several customers who needed R&D materials for chemical stability testing and to perform higher quality TOX studies,” said Tyne Jeffrey, Vice President of Sales at BSM, “and we’re excited to announce that we have expanded our facilities and our team to finally offer this service in-house.
The short-term production of non-sterile pharmaceutical products is essential to provide R&D work, a necessary step in the development of a new drug candidate. Although BSM was initially founded to support the production of clinical study materials and commercial products, it has recently expanded into offering services to support those not yet out of R&D and preclinical studies. . BSM offers extensive development support and will now perform non-GMP engineering cycles to produce hardware for R&D. These non-GMP cycles simulate true GMP manufacturing and serve two important purposes: to provide study material and to serve as early engineering cycles to develop a successful GMP manufacturing process.
“Understanding the client’s needs and working with them in these early stages is helpful in getting them to the clinic faster. It also reduces the risk of formulation failures since our team will already understand all of the materials and technologies that will be used in their cGMP campaign,” said BSM CTO and Co-Founder Dr. Andrea Wagner.
These new services are offered at a reduced cost compared to large-scale engineering cycles and provide similar technologies. Small volumes for animal studies or rapid stability assessments can be performed quickly and inexpensively.
BSM uses only isolator based filler and aseptic formulation. BSM was founded in July 2014, has passed five FDA inspections, and has constantly expanded and improved its site, staff, and services. Their mission is to provide the highest quality pharmaceutical products possible. BSM serves companies of all sizes, from development to commercial parenteral filling and formulation.
Filling Product R&D
Lab Scale Freeze Dryer