Manufacturing Excellence
transforming biologics manufacturing
Bora Biologics delivers an FDA‑inspected, single‑use GMP manufacturing platform designed for commercial performance and regulatory durability. With integrated development and QC capabilities, we support monoclonal antibodies, bispecifics, and advanced biologics from early clinical through licensed commercial supply.
Our Manufacturing Capabilities
We offer a comprehensive suite of services to meet the evolving needs of our clients:
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Full-Service Biologics
Manufacturing -
Next-Gen
Technology -
Expertise in
Various Modalities -
Analytical Method
Development
Full-Service Biologics Manufacturing
From early clinical development through licensed commercial supply, our FDA‑inspected, single‑use GMP platform delivers scalable manufacturing with integrated analytical and QC support. With 20,000L installed capacity across our U.S. network—expandable to 30,000L within our current footprint—we enable reliable global supply across monoclonal antibodies, bispecifics, and advanced biologics.
Next-Gen Technology
Our 100% single‑use infrastructure is designed for operational flexibility, product segregation, and inspection readiness. Platform‑based upstream and downstream processes support commercial batch sizes up to 2,000L, with scalable capacity across multiple production trains.
Expertise in Various Modalities
We support monoclonal antibodies, bispecific antibodies (including DART formats), and ADC programs with integrated process development, characterization, and validation capabilities across the product lifecycle.
Analytical Method Development
In‑house analytical method development, qualification, and validation support drug substance and drug product release, stability programs, comparability assessments, and CQA control strategy documentation from clinical through commercial supply.
Quality Assurance at Every Step
Quality is at the core of everything we do. Our robust Quality Management System (QMS) is designed to ensure compliance with global regulatory requirements, including GMP standards. With a focus on continuous improvement, we implement rigorous testing and validation processes throughout the manufacturing lifecycle.
Quality Control & Assurance
Our mature QMS employs rigorous testing protocols, ensuring the safety, identity, strength, and purity of every product.
Explore Our Quality Control & Assurance ProcessesSupply Chain Management
A robust supply chain is the backbone of a successful biopharmaceutical program, from GMP warehousing to inventory and vendor management.
Explore Our Supply Chain AdvantagesProgram Management
Our timeline-driven collaborative approach ensures your vision is realized, expectations are met, and projects progress seamlessly.
Explore Our Program Management Philosophy
Impressive Achievements
Our FDA‑inspected commercial biologics platform combines scalable single‑use manufacturing, integrated analytical infrastructure, and a proven record of global supply.
State-of-the-Art Facilities
Our U.S. manufacturing network provides 20,000L of installed single‑use GMP capacity across modular cleanrooms and commercial production trains, expandable to 30,000L within our current footprint. Designed for inspection readiness and operational flexibility, our facilities support clinical through licensed commercial supply. Explore Facilities
Proven Track Record
With over 48 biologics and biosimilars developed, over 200 successful GMP batches delivered, active commercial programs supplying 6 global markets, and partnerships with leading pharmaceutical and biotech companies, we have established ourselves as a trusted partner in the biologics industry.
Expert Team
Our team of over 200 scientists, engineers, and regulatory professionals support monoclonal antibodies, bispecifics, and ADC programs with integrated development, process validation, and commercial lifecycle management expertise.
Partner with Confidence
At Bora Biologics, we are dedicated to your success. Our proven track record in tech transfer, combined with our commitment to quality and client satisfaction, positions us as the ideal partner for your biopharmaceutical projects. Together, we can bring your innovations to market efficiently and effectively.
Connect With UsMammalian GMP Manufacturing
precision and excellence in mammalian cell culture
At Bora Biologics, our Mammalian GMP Manufacturing capabilities are designed to meet the highest industry standards, ensuring the production of safe and effective biologics. Equipped with advanced single-use technologies for efficient production, and a commitment to quality, we deliver scalable solutions tailored to your specific needs.
Our mammalian facilities meet stringent GMP guidelines, minimize cross-contamination risks, and facilitate rapid change.
State-of-the-Art Facilities
Our FDA-registered and GMP-compliant global manufacturing network features dedicated mammalian production suites. Facilities include single-use bioreactor technology, purification suites, media and buffer preparation, and full autoclave/wash capabilities — with the flexibility to scale from early clinical to commercial supply.
Mammalian bioreactor capacity includes 20,000L installed capacity, expandable to 30,000L within existing footprint:
- Zhubei, Taiwan: 50L and 500L clinical suites
- San Diego, CA, USA: 50L, 250L, 500L, 1000L, and 2,000L single-use bioreactors with scalability to 5,000L
- Rockville, MD, USA: 500L and 2,000L single-use bioreactors
Robust Cell Line Development
Utilizing our own CHO cell line with cutting-edge techniques for cell line development, we ensure optimal expression and yield of your biologics. Our expertise encompasses a range of mammalian systems, including CHO and HEK293 cells.
Explore CLD Capabilities
Process Development and Optimization
Our experienced team works closely with you to develop and optimize manufacturing processes that enhance product quality, reduce costs, and shorten timelines. We employ advanced technology to ensure the highest quality standards. Integrated across our U.S. and Taiwan GMP network, our process development capabilities support seamless tech transfer from early-stage through commercial manufacturing.
- in-house Water for Injection (WFI)
- AKTA chromatography systems
- automated Tangential Flow Filtration (TFF) skids
- viral filtration skids
- ambr250 bioreactor systems for high-throughput process development
The integration of ambr250 allows us to rapidly evaluate and optimize cell culture conditions, facilitating faster scale-up and improved process efficiency.
Explore Mammalian Process Development Capabilities
Your Success is Our Priority
Bora Biologics’ team, with their extensive experience, profound professional knowledge, and strong international communication skills, has been crucial to the rapid progress of our Nano-TriTE project.
Deputy General Manager, Shine-On BioMedical
Let’s Get Started
If you’re looking for a reliable partner for your mammalian GMP manufacturing needs, contact us today. We are dedicated to supporting your journey from concept to commercialization.
Connect With UsMicrobial GMP Manufacturing
efficient and reliable solutions for microbial-derived biologics
Advanced Microbial Facilities and Technologies
At Bora Biologics, we have been meeting the demand for speed and cost-effectiveness in microbial-derived biologics since 2011. Our commitment to excellence is reflected in our optimized strain selection, fermentation, and purification processes, ensuring that your products are developed and manufactured efficiently.
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High-Yield
Fermentation -
Comprehensive
Downstream
Purification Options - Scalable Production
- AKTA Ready
- Automated TFF Skids
High-Yield Fermentation
Our microbial GMP manufacturing suites are equipped with cutting-edge fermentors that facilitate high-yield fermentation processes, allowing for the production of both secreted and intracellular products.
- 1 x 150L SS Fermentor
- 1 x 300L SUF
Comprehensive Downstream Purification Options
We offer a variety of downstream purification strategies tailored to meet the specific requirements of your biologics, ensuring high purity and activity levels.
Scalable Production
From pre-clinical to commercial scale, our flexible manufacturing capabilities adapt to your project’s needs, enabling seamless transitions throughout the development stages.
AKTA Ready
Our facilities are equipped with AKTA chromatography systems, ensuring efficient and precise purification of your biologics.
Automated TFF Skids
Utilizing automated Tangential Flow Filtration (TFF) skids, we enhance the efficiency and consistency of our purification processes, minimizing manual intervention and reducing risk.
Committed to Your Success
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