NEWTON, Mass., April 17, 2019 /PRNewswire/ — STC Biologics (www.stcbiologics.com) announced today that it has completed construction of a single-use mammalian GMP manufacturing facility in Newton, Massachusetts, and that it 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 (S.U.B.) (expandable to 1000L), and GE ÄKTA™ Ready purification skids.

Massachusetts based biologics CDMO

“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, PhD, President and CEO of STC Biologics. 

STC has established its reputation as a flexible organization that clients can turn to for accelerated low cost programs or custom development when template processes don’t work. 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.

STC Biologics’ management team brings 100+ years of combined drug development experience with a track record of developing products from pre-clinical phase to commercialization, authoring dozens of INDs/CTAs and nine BLAs. “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.”

“The strategic investments and clear expansion path demonstrate our commitment to support clients through all stages of product development,” added Dr. Leszczyniecka.

About STC Biologics

STC Biologics, Inc. is a boutique CDMO located in Newton, MA that provides full CMC services and consulting to enable its partners advance their biologic products from discovery to commercial approval. STC Biologics was founded in 2009 and its team brings expertise in biologics drug development from global biopharmaceutical companies. The cross-training of its scientists in diverse fields with integration of biology into CMC development is what makes STC Biologics unique in its ability to expedite timelines to the clinic. STC Biologics strives to realize “Speed to Clinic” through integrated product development, technical rigor, and flexibility. Contact us at info@stcbiologics.com or come visit us in Newton.

Contact: Magdalena Leszczyniecka, 617-899-0724, magda@stcbiologics.com

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SOURCE STC Biologics, Inc.