Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish CDMO, recently purchased and validated three new analytical instruments to expand its testing and development capabilities.
While the company’s primary service offering is sterile filtration and filling of parenterals, BSM also provides analytical support for drug product lots produced onsite and extensive development services, including method development, to help create and optimize robust methods for in-process or release testing.
The laboratory at BSM is equipped with several UPLCs, HPLCs, UV/Vis spectrophotometers, liquid particle counters, TOC analyzers, Karl Fishers, osmometers, a CCIT leak tester, a sterility isolator with a sterility testing pump, and much more.
New Additions
Recently, BSM added to its laboratory by purchasing Bio-Techne’s next generation imaged capillary isoelectric focusing (icIEF) instrument, the ProteinSimple Maurice. icIEF is a powerful tool commonly used in development of protein-based drugs for product identification, stability monitoring, and characterization. The Maurice icIEF platform is an ideal way to identify and analyze the charge heterogeneity of recombinant proteins, antibodies, and other therapeutic proteins.
“This technology is able to detect changes in charge profiles over time which makes it an excellent solution for evaluating drug product stability,” said Vice President of Quality Control, Devin Wigington.
The icIEF instrument is very sensitive. Protein samples as minute as 0.7 µg/mL can be analyzed, enabling BSM to work with projects where sample amounts are limited. Additionally, turn around for results are quick. Methods can be developed in as little as a day or two and separations are fast – on the order of 6 to 10 minutes. Up to 48 sample vials can be loaded at a time, allowing for quick analyses and large throughput of samples.
BSM has also added inductively coupled plasma mass spectrometry (ICP/MS) and gas chromatography with flame-ionization detection (GC/FID) to its suite of analytical instruments. Both instruments allow for analysis and development of methods that can assess metals and alcohol content.
“We have always been guided by our clients. Our decision to purchase these instruments and expand our services was to best serve our clients and their drug productions,” said Wigington.
BSM has a dedicated team of method development specialists and analytical chemists providing in-process and release testing. These pieces of equipment will enable BSM to do more raw material release and augment some of the tangential flow work it does for clients that work with liposomes.
BSM runs the Maurice, the ICP/MS, and the GC/FID using Waters Empower 3 software. The software is 21 CFR Part 11 compliant, and the system has been qualified for GMP use.
