STC Biologics is a biotechnology company in Cambridge, MA with a hybrid business model; the revenue from our services is utilized to offset the costs of developing our own portfolio of therapeutic products. Our drug portfolio includes a diverse mix of biosimilars and novel biologics. Our services cater to a wide range of product types including peptides, oligonucleotides, targeted liposomes, VLPs, in addition to biosimilars & novel biologics.
Our strategy is to develop biologic drugs from design to proof-of-concept studies in humans, then partner those drugs with companies with commercialization capabilities in different markets.
STC Biologics’ core competencies center on generating biologics drugs with specific product attributes through innovations in process development and analytics, and understanding of drug’s mechanism of action. The technical and regulatory know-how at STC Biologics enables integrated product development planning and successful maneuvering through inevitable development challenges.
Development & Commercialization
Having written over 8 BLAs, dozens of INDs, & 20 comparability protocols & supplemented by experience in the life cycle management of 5 approved biologics, our management team is uniquely positioned to guide our clients to develop an integrated CMC plan tied to preclinical & clinical development with an eye on regulatory expectations. During the last five years, we have advanced our first biosimilar product, STC101, from concept to clinical development in Europe under the EMA guidance. We have also helped our clients overcome complex process & analytical challenges through rigorous & customized efforts.
WHY WORK WITH STC’sTEAM
We become part of your development team by providing flexibility & creative solutions to help you succeed
YEARS IN THE INDUSTRY
Elucidating The Product’s Story For Regulatory Submissions
Save time, money, & avoid aggravation when bringing your product to market
With experience in all phases of product development for a range of biotherapeutics and commitment to advance the products through development, STC Biologics is your preferred strategic partner. We take pride in our ability to become an expert on your product, to go above and beyond in order to drive it through various stages of product development and ultimately successfully tell the story of your product in regulatory submissions.
The time and cost savings of an integrated approach to developing products, not constrained by the boundaries of different departments, has been realized in smart cross-functional organizations. STC Biologics, Inc. is founded on such boundary-less merge of disciplines, as the knowledge of biology, process development, analytics, formulation, and regulatory sciences is in one team body. Our pride in technical rigor, perseverance, critical thinking, and multidisciplinary collaborative work ethics bring agile resolution to technical hurdles and nimble development of products.
STC Biologics possesses more than 70 years of combined drug development experience with a focus on Oncology, Immune Diseases and Infectious Diseases. With our extensive knowledge in these disease areas we are confident in our ability to expedite your drug development by providing disease area specific CMC & regulatory expertise.
We believe that partnerships are very important for value creation and generation of new platforms. If you are interested in a partnership, please contact us below