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Our Facilities

transforming concepts into commercial success

At Bora Biologics, we harness our state-of-the-art facilities and global reach to seamlessly transition your projects from concept to commercialization. Our commitment to quality and innovation drives us to create an environment where cutting-edge technology and experienced professionals work together to bring your ideas to life.

  • 14 years in mammalian and microbial development
  • 45 biologics and biosimilars developed
  • 100 successful cGMP batches delivered
  • 125 expert scientists and regulatory specialists
  • 2 commercially approved biosimilars in U.S. and Canada
  • 1 FDA registered facility specializing in late stage production
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Proven Path to Market

At Bora Biologics, we understand that navigating the path to market for biopharmaceutical products can be complex and challenging. Our facilities are specifically designed to support every stage of product development, from early-stage research to late-stage commercial manufacturing. With state-of-the-art technology, adherence to global regulatory standards, and a commitment to quality, we provide a seamless transition from development to market readiness.

San Diego, CA USA
  • Approved for 2 biosimilars by the FDA and Health Canada
  • Passed every bi-annual FDA inspection
  • Completed Process Characterization and Process Validation through in-house team
  • Late Stage Microbial & Mammalian GMP Manufacturing
EXPLORE
Zhubei, Taiwan
  • Licensed by Taiwan FDA and part of PIC/s to deliver Drug Substance for clinical trials globally
  • Over 15 biosimilars and supplied Drug Substance for Phase I, II, and III Clinical Trials
  • 70% of clients are from the US
  • Early Stage Microbial & Mammalian GMP Manufacturing
EXPLORE
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Schedule a Site Visit

Our facilities are where vision meet precision. If you’re ready to advance your biologics project, contact us today. At Bora Biologics, we are dedicated to supporting your journey from concept to commercialization, ensuring that your needs are met with expertise and precision.

Connect With Us

Bora Biologics
San Diego, CA USA

excellence in commercial GMP manufacturing

Located in the heart of the U.S. Biotech Innovation Hub, our FDA-registered manufacturing facility in Sorrento Valley, San Diego, is designed for excellence. Spanning 130,000 square feet, our state-of-the-art site is equipped with advanced technology and a dynamic team of scientists dedicated to delivering superior results.

Site Overview

FDA Registered Facility

Fully compliant with FDA regulations, ensuring the highest standards of quality and safety.

130,000 sq. ft. GMP and R&D Space

A spacious, modern environment dedicated to both Good Manufacturing Practices (GMP) and research and development.

14,000 sq. ft. Temperature-Controlled GMP Warehouse

Optimally designed for safeguarding product integrity.

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Manufacturing Capabilities

  • Late Stage Commercial GMP Manufacturing Specializing in both microbial and mammalian processes for late-stage production.
  • Mammalian GMP Suites
    • 2 x 50L single-use bioreactors
    • 2 x 250L single-use bioreactors
    • 4 x 1000L single-use bioreactors
    • 2 x 2000L single-use bioreactors (Q1 2026)
  • Microbial GMP Suite
    • 1 x 150L stainless steel (SS) fermentor
    • 1 x 300L single-use fermentor (SUF) with expansion capabilities
  • Pilot Production for Tox and Reference StandardsDeveloping toxicology and reference standards with rigorous validation.
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Advanced Equipment and Technologies

  • HPLC & UPLC SystemsFor high-precision separation and analysis.
  • High-Resolution Mass SpectrometersEssential for detailed molecular characterization.
  • CE-SDS and icIEF SystemsFor protein characterization and purity analysis.
  • MALS and Semi-Preparative HPLC SystemsSupporting advanced analytical needs.
  • Plate Readers and Vi-CELL Automatic Cell CountersFor efficient assessment of cell cultures.
  • qPCR and Biacore™ SPR SystemsFor sensitive molecular analysis and binding studies.
  • UV/Vis SpectrophotometersFor routine analysis of sample absorbance.
  • HIAC Particle Counters and Sievers Total Organic Carbon AnalyzersFor quality control in water and particle analysis.
  • ICH Compliant Stability Storage and Cryo Freezers Ensuring product integrity under controlled conditions.
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Development
Services

Process Development for Drug Substance (DS)
Every project is unique. Our tailored process development services are specifically designed to meet your individual needs, ensuring we deliver solutions that align seamlessly with your goals. Explore

Formulation Development for Drug Product (DP)
Your product’s success depends on its formulation. Our expert team specializes in developing customized formulations that optimize performance and enhance stability. Explore

Analytical & Bio-Assay Development
Accuracy and reliability are crucial in biologics development. Our comprehensive analytical and bio-assay development services provide the rigorous validations you need to ensure your product meets all regulatory requirements and quality standards. Explore

Quality
Assurance

Global Quality Standards
Our consistent adherence to global quality standards is recognized by clients and regulatory agencies. Explore

QC Microbiology
Our stringent testing protocols maintain product integrity and compliance. Explore

All Stability Studies, Including GMP
Comprehensive stability studies are conducted throughout the product lifecycle to ensure your project’s success. Explore

Operational
Excellence

Equipment Validation
Our focus on reliability and consistency in manufacturing ensures quality.

GMP Warehouse and Materials Management
We offer efficient handling and storage of materials, segmented by project. Explore

WFI System & Backup Generators
Ensuring uninterrupted production and supply.

It has been a pleasure working with Bora Biologics on our development molecule. We are impressed with Bora’s work in developing a plan that fits our needs. Their attention to detail and readiness in addressing our project needs have been very helpful. We would be glad to work with them on our future projects.

Project Lead, Prestigious Institute in Boston

Let's Collaborate

If you’re ready to advance your biologics project, contact us today. At Bora Biologics, we are dedicated to supporting your journey from concept to commercialization, ensuring that your development needs are met with expertise and precision.

Connect With Us

Bora Biologics
Zhubei City, Taiwan

excellence in clinical cGMP manufacturing

Located in the vibrant Hsinchu Biomedical Science Park, our Zhubei facility represents a hub of opportunity for early-stage projects. Known for its cutting-edge cGMP clinical manufacturing capabilities, our facility leverages single-use technology and scalable platform technology to support global clinical trials.

Facility Overview

cGMP Clinical Manufacturing Plant

Built to adhere to cGMP standards, ensuring the highest quality in production.

48,000 sq. ft. of  GMP and R&D Space

A dedicated environment for advancing your clinical manufacturing needs.

Qualified Expertise

74% of our employees in Taiwan hold advanced university degrees, including PhDs and Master’s in science, underscoring our commitment to expertise and innovation in the biotechnology sector.

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Manufacturing
Capabilities
  • Early Stage GMP Manufacturing: Specializing in both microbial and mammalian processes, ideal for early-stage projects.
  • Mammalian GMP Suite
    • 2 x 50L single-use bioreactors
    • 2 x 500L single-use bioreactors
    • 2 x 500L single-use bioreactors (Q1 2026)
  • Pilot Production for Tox and Reference Standards: Capable of developing toxicology and reference standards with rigorous validation.
Development
Services
  • Cell Line Development: Expertise in developing robust cell lines tailored to your specific needs.
  • Process/Analytical Development for Drug Substance (DS) and Drug Product (DP): Comprehensive development services to optimize processes for both drug substances and products.
  • QC Microbiology: Dedicated quality control microbiology team ensuring strict adherence to testing protocols.
  • Analytical & Bio-Assay Development: Comprehensive services to ensure accurate assessment and validation of products.
Quality
Assurance
  • Global Quality Standards: Consistently meets global quality standards, recognized by clients and regulatory agencies.
  • 70+ cGMP Batches with 100% Success Rate Since 2014: Our proven track record speaks to our commitment to quality and reliability.
  • Built to cGMP, ICH, FDA, EMA, TFDA, PIC/S Standards: Our facility meets rigorous international standards, ensuring compliance and quality.
Additional
Highlights
  • Temperature-Controlled GMP Warehousing: Ensures optimal storage conditions for sensitive materials.
  • Comprehensive Documentation Practices: Maintains thorough records to support regulatory submissions and audits.

Our Zhubei facility is not just a location; it’s a launchpad for your innovative therapies.
With a focus on collaboration and success, we are ready to partner with you on your next project.

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.