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Who We Are

partners in biopharmaceutical
excellence

At Bora Biologics, we leverage our cutting-edge facilities and global expertise to transform your projects from concept to commercialization. Our unwavering commitment to quality and innovation fosters a collaborative environment where advanced technology and seasoned professionals unite to bring your vision to life.

  • Commercially Approved Biosimilars
    IND to BLA to Commercialization in US and Canada
  • >30 Biologics and >15 Biosimilars Developed
    Experienced Teams
  • FDA Registered Manufacturing Facility
    San Diego, CA, USA
  • Commercial-Scale GMP Manufacturing
    Up to Multiple 2000L’s with Single-Use Technology
  • >100 Successful GMP Batches
    35 Different Products
  • Deep Knowledge and Specialized Skills
    >50% of Employees Hold PhD or Masters Degrees
  • $30M Board Approved Facility Expansion
    Supporting US Manufacturing Demands
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Our History

demonstrated success from IND to BLA

2011 2018 2019 2021 2022 2023 2024 2025 Founded as La Jolla Biologics, Inc. FDA Inspection San Diego FDA Inspection San Diego Launched Tanvex CDMO Services Bora Biologics and Tanvex Merge Tanvex Rebrands as Bora Biologics Name Changed to Tanvex BioPharma USA, Inc. First Drug Approved in Canada FDA Inspection San Diego Nypozi TM Approved Taiwan Site Founded 2014 2016 Taiwan FDA Inspection and Passing Bora Acquires Zhubei facility Bora Biologics Established 2022
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Latest News & Updates

Brochures

Bora Biologics Corporate Overview (PDF)

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Press Releases

Tanvex BioPharma Completes Acquisition of Bora Biologics, Launching New Era in Biologics Development

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Press Releases

Bora Biologics Announces Strategic Collaboration to Accelerate Key CMC Development of DotBio’s Tri-Specific Antibody to Treat Cancer

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Biosphere of Experience

your partner in biopharmaceutical advancement

Sorrento Valley, San Diego, CA, USA
Zhubei, Hsinchu Bioscience Park, Taiwan

Cell Line, Process, Analytical, Bio-Assay,
and Formulation Development

Mammalian & Microbial
Systems

Streamlined Tech Transfer
from PD to Manufacturing

Regulatory Support from IND
to BLA to Commercialization

Commercial Manufacturing
in San Diego

Specialized in biologics, therapeutic
proteins, antibodies, bi/tri specifics, etc

Mature Quality Management System
(QMS)

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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-Elect
Chief Executive Officer
Chief Financial Officer
Chief Commercial Officer
General Manager & Vice President
Vice President, Business & Process Development
Vice President of Taiwan Operations

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

14 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

125 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

US FDA registered GMP manufacturing facility

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.