STC Biologics has completed construction of a single-use mammalian GMP manufacturing facility in Newton, MA, and has successfully conducted its first MCB and three GMP drug substance production runs. This facility includes state-of-the-art, fully disposable equipment, such as a Finesse controller, a Thermo Scientific HyPerforma  500L Single-Use Bioreactor (expandable to 1000L), and GE ÄKTA Ready purification skids.
 
“We selected Newton, MA for our manufacturing site because of its proximity to the hub of biotechnology.  We have an open door policy, where clients can drop by to discuss their projects with our scientists and see their data in real time,” said Magdalena Leszczyniecka, Ph.D., president and chief executive officer of STC Biologics. 
 
STC Biologics introduced the Speed-To-Clinic Platform  for MAbs to go from royalty-free cell line development directly to cGMP manufacturing with released drug substance in twelve months. 
 
“Our Regulatory Science expertise brings a unique value to clients, from devising efficient CMC strategy to providing submission-ready documents,” said Zahra Shahrokh, PhD, chief development officer at STC. “Our expertise in drug product pharmaceutical development facilitates seamless tech transfer to a drug product CMO for speedy timelines from cell line to IND. We have a proven track record of developing commercialized protein formulations, complete biophysical and biochemical product characterization, and rapid delivery of BLA-enabling services such as process characterization, assay validation, in-use studies for IV, subcutaneous and CNS administration.”