CDMO Berkshire Sterile Manufacturing To Fill Initial COVID-19 Injectables For Clinical Trials

Lee, MA /PRNewswire/ - The Berkshires, known for its rich culture and charming green mountain towns has now become a manufacturer of novel treatments and medications to aid in the ongoing pandemic.

Berkshire Sterile Manufacturing (BSM), located in Lee Massachusetts, has been contracted to fill some of the first treatments to aid those afflicted with the novel coronavirus. In early March, the sterile manufacturing company had been contacted by US health officials and other private companies to produce injectable COVID-19 treatments to be used in clinical trials. Since these early inquires, two private companies have tasked BSM with formulating and filling these drugs to treat those suffering from COVID-19.

"It's for people that develop severe lung problems in response to the coronavirus," said BSM's cofounder and CEO, Shawn Kinney. "It could potentially stop the swelling and inflammation in the lungs that contributes to poor outcomes."

BSM is working to get treatments shipped out to the clinic within three weeks of receiving the drug substance which, in the drug industry as Kinney describes, is "moving heaven and earth."

One of the new COVID-19 treatments was filled on Saturday, March 21. Despite the company normally closing for Saturday and early Sunday, several BSM employees offered to work the weekend to produce the medication. Many others worked late nights on the week leading up to the date to prepare. BSM received the drug substance (in powder form) on Friday, and formulated Friday night to start filling early Saturday morning. "Our team is very excited to have been chosen to manufacture this treatment, and they have gone above and beyond the call of duty to get this medication out the door and to the clinic," said Kinney.

Berkshire Sterile Manufacturing was founded in 2014 with the goal of developing a manufacturing process that would produce the safest sterile drug products for clinical use. The company adopted modern technology, including flexible fillers in isolators to achieve sterility assurance unlike anything ever seen in the industry while offering more capabilities and flexibility to their clients' drug productions. This technology in addition with BSM's quality standards and highly trained staff, has resulted in rapid growth of the 5 year old company.

"Berkshire Sterile Manufacturing has changed the industry," said Andrea Wagner, BSM's cofounder and Senior Vice President of Business Development. Wagner cited that several other companies are now adopting similar technologies to compete with BSM's booming business. "BSM is the future. Our modern facility and expert staff are the reasons why our clients' trust us."

In 2021, the company will continue to expand and incorporate new technologies. "We are advancing sterile manufacturing with a new robotic based flexible isolator filling system, which will be operational in mid-2021. This system will have a revolutionary sanitization system for containers to achieve the maximum sterility assurance levels possible," explained Wagner.

When asked if the company predicts it will be producing more COVID-19 treatments in the future, Wagner was certain they would see more interest. "We already have another COVID-19 treatment scheduled for production, and I receive several calls each week from private companies requesting information regarding our ability to expedite fills for the pandemic."

About Berkshire Sterile Manufacturing, Inc.
Berkshire Sterile is a state-of-the-art fill/finish contract manufacturer which specializes in sterile filling of syringes, vials, and cartridges for the biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, lyophilization of vials all within an isolator. Please visit the Company's website (www.BerkshireSterile.com) or contact us at info@berkshiresterile.com for more information.