Our Facilities
transforming concepts into commercial success
Our integrated GMP network is designed to move programs seamlessly from development through commercial manufacturing. Across our U.S. and Taiwan sites, we combine advanced technology, scalable infrastructure, and experienced technical teams to deliver reliable, high‑quality biologics at every stage.
- Proven expertise in mammalian and microbial development
- Extensive experience advancing biologics and biosimilars
- Strong track record of successful cGMP manufacturing campaigns
- Experienced scientists and regulatory specialists
- Commercial manufacturing capabilities in FDA‑registered facilities
Proven Path to Market
Advancing biologics from development to commercialization requires experience, infrastructure, and disciplined execution. Bora Biologics’ integrated GMP network across the United States and Taiwan is purpose-built to support every stage — from early development to clinical supply and commercial manufacturing. With advanced technologies, regulatory rigor, and scalable capacity, we enable a seamless transition from concept to market.
San Diego, CA USA
- FDA-registered facility supporting late-stage clinical and commercial manufacturing
- Proven PPQ execution and inspection readiness
- Active commercial programs delivering supply to 2 global markets
- In-house process characterization and validation expertise
- Mammalian and microbial GMP production capabilities
- Strategic West Coast location supporting U.S. clients
Rockville, MD USA
- FDA-registered facility supporting late-stage clinical and commercial manufacturing
- Proven PPQ execution and inspection readiness
- Active commercial programs delivering supply to 6 global markets
- Mammalian GMP production capabilities
- Strong expertise in tech transfer and lifecycle management
- Strategic East Coast location supporting U.S. clients
Zhubei, Taiwan
- Taiwan FDA–licensed and PIC/S-compliant GMP facility
- Clinical-stage drug substance manufacturing for global trials
- Mammalian and microbial development and GMP production
- Extensive experience supporting biosimilars and innovator programs
- Established U.S. client base
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 UsSan Diego, CA USA
commercial-scale GMP manufacturing excellence
Located in the heart of Southern California’s biotech corridor, our FDA-registered San Diego facility serves as Bora Biologics’ commercial manufacturing hub. Purpose-built for late-stage clinical and commercial production, the site combines scalable infrastructure, regulatory rigor, and deep technical expertise to deliver reliable market supply.
San Diego Site Overview
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FDA-Registered
GMP Facility -
Commercial
Manufacturing Hub -
Scalable Mammalian
& Microbial Suites -
Integrated Process
Validation & PPQ -
Temperature-Controlled
GMP Warehouse
FDA-Registered GMP Facility
Fully compliant with FDA regulations and global quality standards, with a strong inspection history supporting commercial supply.
Commercial Manufacturing Hub
Purpose-built for late-stage clinical and sustained commercial production, including validated processes and lifecycle management.
Scalable Mammalian & Microbial Suites
Single-use mammalian bioreactors and stainless steel/single-use microbial fermentation systems designed for commercial readiness and expansion.
Integrated Process Validation & PPQ
In-house expertise supporting process characterization, validation campaigns, PPQ execution, and regulatory submissions.
Temperature-Controlled GMP Warehouse
14,000 sq. ft. controlled storage and logistics infrastructure supporting raw materials and finished product management.
Manufacturing Capabilities
- Late-Stage Commercial GMP Manufacturing Supporting both mammalian and microbial production programs through validation and PPQ to sustained commercial supply.
- Mammalian GMP Suites Single-use bioreactor platforms supporting clinical through commercial scale, with expansion capability to larger volumes.
- Microbial GMP Suite Stainless steel and single-use fermentation systems designed for late-stage and commercial microbial programs.
- Process Characterization & ValidationIn-house expertise supporting regulatory filings, PPQ campaigns, and ongoing process optimization.
- Pilot Production for Toxicology and Reference StandardsDedicated capabilities for tox material and validated reference standard manufacturing.
Advanced Equipment and Technologies
- Chromatography & Purity AnalysisHigh-performance liquid chromatography (HPLC/UPLC) and semi-preparative systems for precise separation and purity assessment.
- Mass Spectrometry & Molecular CharacterizationHigh-resolution mass spectrometry supporting detailed structural and molecular analysis.
- Charge & Size Variant AnalysisCE-SDS and icIEF platforms for in-depth characterization of protein integrity and heterogeneity.
- Binding & Functional StudiesBiacore™ SPR systems and cell-based analytical platforms for interaction and potency evaluation.
- Cell Culture & Process MonitoringAutomated cell counters, plate readers, and qPCR systems for robust upstream process control.
- Quality & Environmental MonitoringTOC analyzers, particle counters, and UV/Vis spectrophotometers ensuring GMP compliance and water quality.
- ICH-Compliant Stability & Cold StorageControlled stability chambers and cryogenic storage supporting long-term product integrity.
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 UsRockville, MD USA
commercial-scale GMP manufacturing excellence
Strategically located in Maryland’s biotech corridor, our Rockville facility expands Bora Biologics’ U.S. commercial manufacturing network. Designed for multi‑product flexibility and scalable single‑use production, the site supports sustained commercial supply with strong quality systems, robust utilities, and integrated QC laboratories.
Rockville Site Overview
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FDA-Registered
GMP Facility -
Commercial
Single-Use Suites - Multi-Product Facility Design
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Integrated QC
Laboratories & Utilities -
GMP Warehouse
& Logistics
FDA-Registered GMP Facility
Operates under U.S. FDA regulatory oversight with established quality systems and inspection history supporting commercial supply.
Commercial Single-Use Suites
5 x 2,000L and 2 x 500L single‑use bioreactors designed for commercial-scale mammalian production.
Multi-Product Facility Design
Segregated suites and controlled workflows supporting concurrent manufacturing campaigns.
Integrated QC Laboratories & Utilities
On-site QC laboratories, water systems, clean utilities, and environmental monitoring supporting GMP operations.
GMP Warehouse & Logistics
Temperature-controlled warehouse space supporting raw material and finished product management.
Manufacturing Capabilities
- Commercial Mammalian GMP ManufacturingSingle‑use bioreactor platforms supporting validated processes and sustained commercial production.
- Upstream & Downstream ProcessingIntegrated cell culture, purification, and filtration operations designed for consistency and scalability.
- Process Validation & Lifecycle ManagementExecution of validation campaigns, PPQ readiness, and ongoing process optimization.
- Quality Control TestingComprehensive in-house analytical testing supporting release, stability, and environmental monitoring.
Advanced Equipment and Technologies
- Single‑Use Bioreactor PlatformsCommercial-scale 2,000L and 500L systems designed for flexibility and rapid changeover.
- Purification & Filtration SystemsChromatography, ultrafiltration/diafiltration, and depth filtration supporting downstream processing.
- QC & Analytical LaboratoriesTesting capabilities supporting identity, purity, potency, and microbiological control.
- Robust Utility InfrastructureClean steam, WFI, HVAC, and controlled environments supporting GMP compliance.
We’ve partnered with the Rockville facility for 7+ years for manufacturing early- and late-stage clinical and commercial material. The staff is competent and committed, understanding customer’s needs and willing to be flexible to meet often aggressive milestones. Their internal systems are mature and robust, maximizing the potential of their well-maintained manufacturing plant. We will continue to rely on our strong partnership to support our Biologics programs.
Senior Director, External Manufacturing at a global pharmaceutical company
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 UsZhubei City, Taiwan
first‑in‑human cGMP center of excellence
Located in Hsinchu Biomedical Science Park, our Zhubei facility serves as Bora Biologics’ First‑in‑Human (FIH) manufacturing center. Purpose-built for early-stage biologics, the site integrates development expertise with flexible cGMP operations to accelerate molecules from process development into clinical evaluation with speed, precision, and regulatory confidence.
Zhubei City Facility Overview
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First‑in‑Human
cGMP Center -
PIC/S-Compliant
Manufacturing Facility -
Integrated Development
& GMP Operations -
Scalable Mammalian
& Microbial Platforms -
GMP & R&D
Infrastructure
First‑in‑Human cGMP Center
Dedicated to manufacturing drug substance for initial clinical studies, with flexible scheduling and rapid turnaround to support IND-enabling timelines.
PIC/S-Compliant Manufacturing Facility
Built and operated to international GMP standards, supporting global regulatory submissions.
Integrated Development & GMP Operations
Seamless collaboration between process development and GMP teams to reduce tech transfer risk and accelerate clinical readiness.
Scalable Mammalian & Microbial Platforms
Single-use mammalian bioreactors and microbial fermentation systems designed for efficient scale-up and transfer to commercial sites.
GMP & R&D Infrastructure
48,000 sq ft of modern cleanroom suites and development laboratories located within Taiwan’s leading biotech ecosystem.
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.
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