By Josh Landes
Berkshire Sterile Manufacturing’s home is a nondescript warehouse off route 102 just south of Lee, Massachusetts.
“We do sterile fill finish pharmaceutical injectable drug products,” said Shawn Kinney, president of BSM. “Our customers are usually pharmaceutical and biotech companies. They will ship us their raw material, the chemical – the drug substance, if you would.”
From that raw material, a usable drug is created. BSM makes a full batch, adjusts factors like concentration and strength, and then sterile filters it and loads it up in vials, syringes, or cartridges.
“We work primarily with companies that are in clinical phase, new drug molecules being investigated for a variety of different sickness, illnesses that need to be cured,” said Kinney.
“We current have been approached by three different companies, all three of which have been our clients, and each of them have a COVID treatment,” said Andrea Wagner, BSM’s Senior Vice President of Business Development. “The issue with COVID is that it basically blocks the lungs from distributing oxygen to your body, and these treatments are designed to open up your airways and get oxygen through.”
Kinney says that each of the three companies – who cannot be named due to confidentiality agreements – are approaching the problem from a different vantage point. One of the drug molecules attacks inflammation.
“The problem with many of these patients that get pneumonia is the inflammation of the lungs, and if they can disrupt the inflammation process so you don’t get inflammation these patients will be able to continue to breathe and hopefully do well,” explained Kinney.
Another drug boosts the immune system.
“They’re hoping if they can boost the immune system of people that some of them won’t get to the advanced stages of pneumonia they see,” said Kinney.
The third seeks to expand how much oxygen the lungs can take in.
“They’re hoping that in these cases where people are having difficulty to breathe, that if they can improve the oxygen uptake that that will help in the later stages of the disease,” Kinney said.
It’s all hands on deck to rush production of the experimental COVID-19 treatments.
“We have the process engineers that have to write the manufacturing direction and records that are required,” explained the company’s president. “Of course, the manufacturing folks are doing the manufacturing. We’ve got the quality control people that are doing all the testing to release all the materials into manufacturing and then testing the final drug product to ensure it meets all of its quality attributes. The quality assurance group then very important in reviewing all the documentation and giving the final release of the product to the clinic.”
All 150 or so BSM employees are working overtime to finish the job.
“The employees here are very proud to be able to do something to help the situation that’s going on right now,” said Kinney. “They’ve all volunteered to come in for their weekend to do the work that’s necessary. We are giving them all bonuses to do this, but even if we didn’t, I feel that all of these employees would be in here working just as hard.”
Wagner says a fast-tracked production schedule would normally mean a turnaround time of 6 to 8 weeks or longer.
“So in this case we were approached by the client approximately a week and a half ago,” she told WAMC. “We’ve already done the filling for that. It’s under test currently, and it will be shipped out of here as soon as we get the release from our quality group and our quality control group. And so we’re targeting about two and a half weeks from Monday, this coming Monday – so we’ve been able to turn this around in a matter of three and a half weeks.”
BSM is now hiring to further expand its operations.
Read full article: Berkshire County Company Producing New COVID-19 Treatments