Bora Biologics Information

Bora Biologics | U.S.-Based Commercial Biologics CDMO Bora Biologics is a U.S.-based Contract Development and Manufacturing Organization (CDMO) specializing in commercial-stage biologics manufacturing and GMP drug substance production. We support biopharma innovators with inspection-ready manufacturing, disciplined technology transfer, and scalable process execution from late-stage development through sustained commercial supply. With more than 100 successful cGMP manufacturing batches and experience supporting over 50 biologics and biosimilars, our platform is built for regulatory durability and operational consistency. Our focus is execution — delivering reliable, repeatable commercial manufacturing supported by robust quality systems and experienced operational leadership. Core Capabilities + GMP Drug Substance Manufacturing (Mammalian and Microbial) + Late-Stage Clinical and Commercial Production + Process Validation (PPQ) and Commercial Readiness + Technology Transfer and Scale-Up + Integrated Process and Analytical Development + Quality Control and Quality Assurance We manufacture monoclonal antibodies (mAbs), bispecifics, fusion proteins, recombinant proteins, and other complex biologics within FDA-registered facilities designed for commercial scalability. U.S. Manufacturing Headquarters San Diego, California + FDA-registered GMP facility + 130,000 sq ft GMP and R&D space + Commercial-scale single-use bioreactors up to 2000L (with accommodation for 5000L) + GMP warehouse and controlled storage + Dedicated GMP manufacturing suites Taiwan Manufacturing Operations Zhubei City, Taiwan + 70+ successful cGMP batches since 2014 + cGMP-compliant facilities supporting global regulatory standards (FDA, EMA, PIC/S) + Integrated manufacturing and development infrastructure At Bora Biologics, commercialization is not an endpoint — it is the operating standard.