Who We Are
partners in biopharmaceutical
excellence
An integrated global CDMO advancing biologics from First‑in‑Human to commercial supply
Bora Biologics is a global biologics CDMO delivering end‑to‑end development and GMP manufacturing solutions. With integrated clinical and commercial capabilities across Asia and the United States, we partner with innovators to accelerate programs from IND-enabling development through sustained commercial supply.
Our teams combine deep scientific expertise, scalable infrastructure, and regulatory excellence to move molecules forward with speed, quality, and confidence.
- End‑to‑End Biologics Lifecycle Expertise
From cell line development and IND-enabling activities through PPQ and sustained commercial supply across global markets. - First‑in‑Human to Commercial Manufacturing Network
Integrated clinical and commercial GMP operations in Zhubei City, Taiwan, San Diego, California, and Rockville, Maryland. - Commercially Approved Programs
IND through BLA to commercialization supplying 6 global markets. - Robust Development & GMP Track Record
Over 48 biologics and biosimilars developed. - >200 Successful GMP Batches
Including over 60 commercial batches. - Commercial-Scale Single‑Use Capacity
20,000L installed capacity supporting validated processes and sustained market supply, and scalable to 30,000L within current infrastructure. - Regulatory & Scientific Depth
Experienced CMC, quality, and regulatory teams, with >50% of employees holding advanced degrees. - Committed to U.S. Growth & Market Supply
Over $150M contributed to U.S. commercial capacity offering in 2025-2026.
Our History
building success from IND to commercial scale
Biosphere of Experience
your partner in biopharmaceutical advancement
San Diego, CA USA
Rockville, MD USA
Zhubei City, Taiwan
Cell line, process, analytical,
bioassay, and formulation development
Mammalian & Microbial
Systems
Streamlined Tech Transfer
from PD to Manufacturing
Regulatory Support from IND
to BLA to Commercialization
U.S.-Anchored Commercial
Manufacturing
Antibodies, therapeutic proteins, and
complex biologics across modalities
Commercial-Ready
Quality Systems
- Extensive ExpertiseOur team has successfully advanced numerous biologics from Investigational New Drug (IND) applications to Biologics License Application (BLA) submissions, providing deep regulatory insight that meets unique client needs.
- Mature Quality Management SystemOur QMS has been refined through multiple regulatory inspections, ensuring robust, compliant processes that deliver safe and effective pharmaceuticals. Quality is the cornerstone of our operations.
- Innovative Scientific TeamOur scientists excel in both process and analytical development, leveraging creativity and efficiency to support biosimilar and novel antibody therapeutics.
- Comprehensive Analytical CapabilitiesWe optimize processes and uphold the highest standards of quality and efficacy, ensuring our clients receive exceptional support throughout development.
- Collaborative PartnershipWe integrate seamlessly with your team, providing dedicated support from pre-clinical stages to commercial manufacture, guiding your biologic through every phase with expertise and care.
Leadership Team
veteran leaders shaping the future of biologics
Bora Biologics
the logical choice
Join the ranks of biopharma pioneers who trust us.
Explore how we minimize risks and accelerate your success.
Client-Centric
100% commitment to supporting your success
Experience
15+ years developing & manufacturing biologics
Expertise
Over 200 seasoned scientists & regulatory professionals
Commercial-Ready
2 US FDA registered GMP manufacturing facilities
Allied
access to global CDMO resources