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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.
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Our History

building success from IND to commercial scale

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Latest News & Updates

Press Releases

Bora Biologics Expands U.S. Commercial Manufacturing Platform with Addition of Rockville Site

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Events

2026 BPI Boston Presentation: Advancing CHO Cell Line Development

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Press Releases

Bora Completes Acquisition of MacroGenics’ Rockville Manufacturing Operations for $122.5M

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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

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  • 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

Chairman
Chief Executive Officer
Chief Financial Officer
Chief Commercial Officer
General Manager & Vice President
Senior Vice President, Technical Operations
Vice President of Taiwan Operations
Vice President, Process Development & MSAT

Bora Biologics

the logical choice

Join the ranks of biopharma pioneers who trust us.
Explore how we minimize risks and accelerate your success.

Partner with us

Client-Centric

100% commitment to supporting your success

We have been the client, bringing multiple biologics from IND to BLA. Your needs and goals are at the forefront of our approach. By involving you in every step of the process, we ensure transparency and alignment, reducing the likelihood of misunderstandings and ensuring the outcome meets your expectations.

Experience

15+ years developing & manufacturing biologics

We have honed our ability to navigate complexities. Our track record from concept to commercialization means we can apply best practices and lessons learned, ensuring smoother project execution.

Expertise

Over 200 seasoned scientists & regulatory professionals

Our team exudes deep knowledge and specialized skills, with over 50% holding advanced degrees. This expertise allows us to foresee potential challenges and implement proactive solutions, reducing the likelihood of setbacks.

Commercial-Ready

2 US FDA registered GMP manufacturing facilities

We focus on delivering solutions that are ready for market. With clinical to commercial scale facilities consistently meeting compliance standards, we ensure your project is primed for success, minimizing the risk of costly revisions or delays.

Allied

access to global CDMO resources

Our partnership with Bora Pharmaceuticals provides additional resources and insights. This network enables us to leverage shared knowledge and expertise, further mitigating risks and accelerating the overall success of your project.