03.22.23
Woodstock Sterile Solutions, a blow-fill-seal (BFS) contract development and manufacturing organization (CDMO), has completed an expansion of its quality control analytical lab at its production facility in Woodstock, IL. The larger lab accommodates additional testing equipment and additional experts to perform the method development work and ongoing product release and stability testing now possible in house. With these expanded capabilities, the company can now provide services from development through commercial release.
“At Woodstock Sterile Solutions, quality is our passion, and with this investment, we are further developing our in-house quality control program,” said CEO Paul Josephs. “Our manufacturing team can now more easily collaborate with our quality team, improving coordination and ensuring on-time delivery. Having production and on-site quality control laboratories together under the same quality system also helps to improve effectiveness and accelerate continuous development.”
Biocompatible HPLC and UPLC systems have been added to Woodstock's lab to enable drug purity and potency testing, as well as detection of impurities and other unwanted components. These systems have been specifically designed to minimize interactions between system components and biological samples to reduce the risk of contamination. Additionally, the lab now includes Malvern Mastersizer 3000 and Zetasizer particle analyzers, which determine the optimal particle size range for products to ensure they meet specifications.
“The expansion of our analytical lab will help us to reduce cycle times for finished product release and stability testing and enable us to further streamline issue resolution. Having manufacturing and testing all under one roof also helps us to deliver on our promise to be a one-stop-shop CDMO for customers,” said Dr. Kuljit Bhatia, Chief Scientific Officer at Woodstock Sterile Solutions.
“At Woodstock Sterile Solutions, quality is our passion, and with this investment, we are further developing our in-house quality control program,” said CEO Paul Josephs. “Our manufacturing team can now more easily collaborate with our quality team, improving coordination and ensuring on-time delivery. Having production and on-site quality control laboratories together under the same quality system also helps to improve effectiveness and accelerate continuous development.”
“The expansion of our analytical lab will help us to reduce cycle times for finished product release and stability testing and enable us to further streamline issue resolution. Having manufacturing and testing all under one roof also helps us to deliver on our promise to be a one-stop-shop CDMO for customers,” said Dr. Kuljit Bhatia, Chief Scientific Officer at Woodstock Sterile Solutions.
