Bora Biologics

Bora Biologics: Accelerating Success in Biologics Development With a proven track record of over 100 successful cGMP manufacturing batches and the development of more than 42 biologics and biosimilars, Bora Biologics exemplifies how experience drives success. We offer agile, comprehensive end-to-end CDMO solutions that optimize time and cost efficiencies for biopharma companies around the world. Leveraging our global CDMO capabilities, our state-of-the-art, FDA-registered facility in the U.S., and our deep expertise in biologics development and manufacturing, we provide efficient and effective pathways to market for clients. We specialize in a diverse range of biologics, including monoclonal antibodies (mAbs), bi-specifics, fusion proteins, recombinant proteins, and enzymes. From cell line development to commercial manufacturing, our team brings extensive global and regional regulatory affairs expertise to ensure compliance and success at every stage of the process. + Mammalian and Microbial GMP Manufacturing + Early, Late-Stage and Commercial Production + Integrated Process and Analytical Development + Formulation and Drug Product Development + Quality Control and Assurance State-of-the-Art Facilities & Highlights --------------- Bora Biologics | San Diego, California, USA +FDA Registered +130,000 sf GMP and R&D space +14,000 sf temperature controlled GMP warehouse +Single-Use Bioreactors (SUBs): 2 x 50L, 2 x 250L, 4 x 1000L , 2 x 2000L (in plan) +Stainless Steel Fermentors: 1 x 150L, 1 x 300L (SUF) +3 GMP suites Bora Biologics | Zhubei City, Taiwan +70+ cGMP batches with 100% success rate continuously since 2014 +48,000 sf of GMP and R&D space +cGMP, ICH, FDA, EMA, TFDA, PIC/S +Single-Use Bioreactors (SUBs): 2 x 50L, 4 x 500L (2 in plan) Partner with us today to discover how our EXPERIENCE can accelerate your success.