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Lee biopharmaceutical company manufactures treatments to aid in fight against coronavirus pandemic

Brittney White, a microbiologist at Berkshire Manufacturing and resident of Pittsfield, is among several workers who is working on the COVID-19 project. (Berkshire Sterile Manufacturing)

LEE — A south county-based biopharmaceutical firm is manufacturingtreatments that are designed to help the afflicted battle the symptoms ofcoronavirus disease. BerkshireSterile Manufacturing, located on Pleasant Street, has been contracted by threeclients to formulate and manufacture four novel treatmentsand medications to aid in the ongoing pandemic, according to Shawn Kinney, CEO of the company.Healthofficials in the U.S. and other private companies reached out to Berkshire Sterile in March to see if the Lee firm could produce injectable COVID-19 treatments that would be used in clinical trials, said Kinney.“These medications we’re making right now are not vaccines. They won’t cure coronavirus disease, but they could potentially stop the swelling and inflammation in the lungs,” he said. “[The treatments] are for people that develop severe lung problems in response to the coronavirus.” The treatments disrupt the inflammation process,thus allowing people to breathe, and boosts the immune system, so that an afflicted person can better fight off the coronavirus, said Kinney.“The hope is that these medications will help reduce [patients’] stay on ventilators and make them more available for more serious patients,” he said. One of the treatments was filled on Saturday,March 21 and will hopefully be shipped out by this Friday, said Kinney. Two of the treatments will be sent to clients in France and the other to somewhere in the U.S., he added. While some companies may be struggling undercurrent conditions caused by the global pandemic, Kinney says Berkshire Sterilehas seen an uptick. Traditionally, the firm is closed on Saturday andearly Sunday morning, but several employees agreed to work overtime to producethe medications. As of Monday, April 6, the company has a staff of 149 and isstill looking to fill another 22 positions, according to Jennifer Kratovil-Moriarty, seniormanager of human resources. The company received the drug substance in powderform on Friday, March 20, formulated Friday night to start filling early in themorning on Saturday, March 21. “Our employees help produce potentiallylife-saving medications that are used in clinical trials, and take great pridein that, but with the prevalence of COVID-19 on the news, they’ve taken pridein recognizing the part they’re having in filling these treatments,” saidKinney. Dr. Xufeng Sun, director of formulation andtechnology transfer at Berkshire Sterile, noted that for the week of March 29alone, the company filled 5,000 units for the treatment of Parkinson’s Disease,5,000 units to be used in helping patients in heart failure, and 3,500 unitsfor treating relapsed or refractory non-Hodgkin lymphoma, for three differentclients. Berkshire Sterile was established in 2014 with afocus on contract manufacturing of sterile drugs in pre-clinical and clinicalphases for companies in the pharmaceutical, biotech and medical deviceindustries. Last year, MassDevelopment, the state’s finance anddevelopment agency, awarded the company a $2 million loan for the expansion ofits building. The company has been using that funding toward the expansion ofits cleanroom and warehouse facilities and construction of new visualinspection and final drug packaging suites. It also purchased additionalsterile manufacturing equipment. While that expansion is complete, BerkshireSterile is poised for another expansion that will incorporate new technology anddouble the size of the company’s existing 45,000 square-foot clean room. Theestimated $15-to-$20 million expansion will include installing a newrobotic-based flexible isolator-filling system. Kinney said he anticipates the expansion to be completed by 2021. Theexpansion is set to start immediately following bank approval. 

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