Company Category: Regulatory / CMC Documentation

WHO ARE WE STC Biologics, Inc is a fully integrated CDMO located in Newton MA, USA that provides full CMC Services and Consulting for drug developrs to advance their biologic products from discovery to commercialization. Founded in 2009, the Team brings deep expertise in biologics drug development and global regulatory approvals from a “who’s who” list of companies like Genentech, Novartis, Shire, EMD Serono, Lonza, Alexion and Merrimack. The holistic view of drug development with the integration of biology into CMC development, and the cross-training of its scientists in those diverse fields is what makes STC unique in its ability to expedite timelines to the clinic. STC strives to REALIZE “SPEED TO CLINIC” THROUGH INTEGRATED PRODUCT DEVELOPMENT, TECHNICAL RIGOR, AND FLEXIBILITY. CORE COMPETENCIES STC Biologics’ core competencies center on biologics drug development starting from cell line generation for high expression levels, process, analytical and formulation development to GMP production. The technical and regulatory know-how at STC Biologics enables integrated product development planning and successful maneuvering through inevitable development challenges. STRATEGY STC has established its reputation as a flexible organization that clients can turn to for accelerated low-cost programs through our Speed-To-Clinic Platform™, or for custom development when template processes don’t meet the needs of complex products. STC introduced Speed-To-Clinic Platform™ for MAbs starting from royalty free Cell Line Development directly to cGMP Manufacturing and released Drug Substance, all within a 12-month cycle – even for challenging proteins. 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? Executive Team with over 100 years in the industry; Over 100 assays developed; 18 INDs filed; 8 BLAs filed. By Phase 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. By Service 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. At STC Biologics, we specialize in providing end-to-end solutions for biopharmaceutical development and manufacturing. Our team of experts is dedicated to delivering high-quality and innovative services, including: • Cell Line Development: Customizable and efficient cell line development tailored to meet your specific requirements – high-titer results o For complex molecules (e.g. multi-specifics): developability, manufacturability, high-order analytics • Process Development: Comprehensive process development, optimization, and scale-up for both upstream and downstream processes. • Analytical Services: Robust analytical testing and characterization to ensure product quality and compliance with regulatory standards. • Formulation development: Complex, sensitive and high concentration formulations • cGMP Manufacturing: State-of-the-art cGMP manufacturing facilities for clinical production. • Bioconjugation chemistry for: ADCs, radiopharmaceuticals, Oligos Leadership: Dr. Magdalena Leszczyniecka, PhD. MBA. President and CEO of STC Biologics Email: magda@stcbiologics.com Magdalena founded STC Biologics Inc. in 2009 with a goal to bring biosimilar products to patients who cannot afford branded equivalents. Since 2009, STC has worked on four biosimilar antibody products, some being developed in-house and others for STC’s partners. As a leader in the biosimilar sector, she presents at key biosimilar business conferences each year, is an strategy advisor to Sectoral Asset Management and consults on biosimilars for Coleman Research (a company focused on providing market research for buy-side investors). She has three patents relating to biosimilar product optimization, covering methods to achieve fingerprint-like similarity in product quality. STC’s main goal is to bring a biosimilar product to the market with reduced burden of clinical trials by providing fingerprint analytical data on product similarity. Magdalena has a broad drug development experience in small molecules and various biologics including IgG1, IgG4, two Fc fusion proteins, antibody single chains, and antibody targeted liposomal formulations. She gained start up experience prior to STC working for venture capital firms: Flagship Ventures and Atlas Ventures. She has led the development of MM-121 and anti-HER3 antibody programs at Merrimack Pharmaceuticals. In 2002, she started her scientific career at Novartis Pharmaceuticals as a project leader for two oncology development products. She received her Ph.D. from a joined program between Columbia University and NYU, an MBA from Babson College, and a B.S in Biochemistry from Rutgers University. Dr. Zahra Shahrokh, PhD. Chief Development Officer at STC Biologics Email: zshahrokh@stcbiologics.com Zahra brings a broad experience in biotechnology product development with a track record in global regulatory approvals of 5 biological products (Replagal, Elaprase, Dynepo, VIPRIV, Firazyr) and in the clinical development of dozens of novel biologics. She has more than 25 years experience in biopharmaceutical development: 10 years at Genentech as Senior Group Leader in Pharmaceutical Development and CMC team leader, 10 years at Shire HGT as both Head of Pharmaceutical and Analytical Development and then Head of CMC Program Management, followed by another 4.5 years as a CMC consultant. At STC Biologics, she provides strategic and technical leadership for the development of internal and client products, including biosimilars, antibody based products, viral products, and targeted liposomal products. At Shire, she built organizational capabilities throughout the company’s growth phase from a start-up company (known as TKT) towards a multi-billion dollar commercial organization. She had oversight of formulation & drug product manufacturing process development, tech transfer, analytical development & process development analytical operations, specifications development & comparability, product characterization, and clinical GMP testing & stability programs. Furthermore, she held roles such as Chair of Quality Standards Committee and Program Executive for the CNS projects, at Shire. She designed and instituted Shire’s first CMC Program Management system to transform the effectiveness of product development teams. She was a CMC representative in regulatory agency meetings, formulated responses to questions, and managed implementing CMC strategy within the department. She had technical and leadership roles at Genentech’s Pharmaceutical R&D department, and prior to that at Scios Nova, where she drove pharmaceutical development of several classes of biologics and small molecules. Zahra has a post-doctoral fellowship at UCSF, PhD in Biophysics from University of California, Berkeley and a dual BA degree in Chemistry and Physics from University of Pennsylvania, Philadelphia. She holds several pharmaceutical patents and over 60 papers and invited presentations. For the past 10 year she has been an invited lecturer in Biotechnology at the University of Kansas, Pharmaceutical Chemistry department, and an active member of the Organizing Committee for WCBP and “CMC Strategy Forum” that brings together regulators and biotech industry to present and debate current topics in product development in the context of globalization and regulatory sciences.