Bora Biologics

About Bora Biologics

𝗕𝗨𝗜𝗟𝗧 𝗙𝗢𝗥 𝗖𝗢𝗠𝗠𝗘𝗥𝗖𝗜𝗔𝗟 𝗲𝗻𝗴𝗶𝗻𝗲𝗲𝗿𝗲𝗱 𝗳𝗼𝗿 𝘀𝗰𝗮𝗹𝗲 Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply. 𝗢𝘂𝗿 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺 𝗭𝗵𝘂𝗯𝗲𝗶, 𝗧𝗮𝗶𝘄𝗮𝗻 – 𝗜𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗲𝗱 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗖𝗲𝗻𝘁𝗲𝗿 𝗼𝗳 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 Cell line development, process and analytical development, formulation, and First‑in‑Human clinical drug substance manufacturing — structured for seamless tech transfer to U.S. commercial facilities. 𝗦𝗮𝗻 𝗗𝗶𝗲𝗴𝗼, 𝗖𝗔 & 𝗥𝗼𝗰𝗸𝘃𝗶𝗹𝗹𝗲, 𝗠𝗗 – 𝗕𝗶‐𝗖𝗼𝗮𝘀𝘁𝗮𝗹 𝗨.𝗦. 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 20,000L installed single‑use bioreactor capacity (scalable to 30,000L within existing infrastructure), 100% single‑use drug substance manufacturing, and FDA‑registered GMP facilities designed for PPQ, BLA, and licensed supply. 𝗣𝗿𝗼𝘃𝗲𝗻 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻 • 3 active commercial programs supplying 6 global markets • 100% first‑pass PPQ success • >200 GMP batches executed, including >60 commercial batches • >48 biologics and biosimilars developed • >$150M invested in U.S. commercial expansion (2025–2026) Our global tech transfer pathway, mature quality systems, and experienced CMC leadership team reduce lifecycle risk and eliminate the disruption often caused by transitioning between clinical and commercial CDMOs. We partner with innovators developing antibodies, therapeutic proteins, and complex biologics across modalities — delivering clinical supply with commercial certainty.