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Berkshire Sterile Manufacturing Expands Services

Capabilities now include R&D and TOX lot formulation and filling.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Following their recent expansion into formulation, method and lyo development, Berkshire Sterile Manufacturing (BSM) now offers two new services to assist their clients in their R&D efforts as they head towards clinical development and trials. 

“We’ve had several clients that needed R&D material for chemical stability testing and to perform higher quality TOX studies and we are thrilled to announce that we expanded our facility and team to finally offer this service in house,” said Tyne Jeffrey, vice president of sales, BSM.

Short-term production of non-sterile drug products is critical to supplying R&D work—a necessary step to developing a new drug product candidate. Though BSM was initially founded to support the production of clinical study material and commercial products, they have recently expanded into offering services to support those that have not yet stepped out of R&D and into pre-clinical studies. BSM offers significant development support and will now perform non-GMP engineering runs to produce material for R&D. These non-GMP runs simulate real GMP manufacturing and serve two significant purposes: to supply study material and to serve as early engineering runs to develop a successful GMP manufacturing process.

BSM’s chief technical officer and co-founder, Dr. Andrea Wagner, said, “Understanding the client’s needs and working with them at these early stages is helpful to getting them into the clinic faster. It also reduces the risk of formulation failures since our team will already understand all the materials and technology that will be used during their cGMP campaign.”

These new services are offered at reduced cost compared to full-scale engineering runs, and it provides some similar technologies. Small volumes for animal studies or quick stability assessments can be performed quickly and cost effectively.

BSM utilizes only isolator-based filling and aseptic formulation. BSM was founded in July of 2014, has undergone five FDA inspections, and has consistently expanded and improved its site, staff, and services. Their mission is to provide the highest quality drug products achievable.  BSM serves companies of all sizes from development through commercial parenteral filling and formulation.

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