At Bora Biologics, we empower your success in analytical development and product characterization with tailored solutions and cutting-edge instrumentation, enabling seamless method development, qualification, and validation for timely lot testing and release. Experience how we bring solutions to market faster and more cost-effectively, so you can focus on what matters most: your success.

• Identity & Purity
• Structural Characterization
• Mechanism of Action
• Microbiology
• Analytical Validation

Bora Biologics elevates your formulation development with innovative solutions and state-of-the-art technologies. Our collaborative approach ensures efficient formulation strategies, enabling you to bring products to market faster and more cost-effectively.

• Allosteric FD Platform
• Biophysical HT Platform
• Analytical Platform
• Customized Formulations
• Stability Studies

Bora Biologics offers full-service GMP manufacturing resources and capacity to expedite your mammalian and microbial projects. With a proven track record spanning preclinical to Investigational New Drug (IND) applications to Biologics License Applications (BLA) to commercialization, and a U.S. FDA and Health Canada approved biosimilar, our experience makes us a reliable partner.

• FDA Registered Facility in San Diego, CA, USA
• TFDA Registered Facility in Zhubei City, Taiwan
• Clinical and Commercial Production
• Multiple GMP Manufacturing Suites
• 10+ Single-Use Bioreactors (SUBs)
• 8+ Stainless Steel Fermentors
• >175,000sf GMP and R&D space
• Temperature-controlled GMP warehouse

Quality is a non-negotiable at Bora Biologics. Our mature quality management system employs rigorous testing protocols, ensuring the safety, identity, strength, and purity of every product. With meticulous testing, validation, and monitoring, we ensure your product meets or exceeds regulatory benchmarks.

• QC Testing / Validation / Monitoring
• QA Systems / Operations / Engineering
• End-to-End Regulatory Support

Bora Biologics believes a robust supply chain is the backbone of every successful biopharmaceutical program. We have successfully navigated the path from concept to market and share our experience and know-how to keep your projects on track.

• GMP Warehousing
• Vendor Management
• Inventory Management
• Packaging / Shipping / Fulfillment

At Bora Biologics, your success is our success. Our timeline driven collaborative approach ensures your vision is realized, expectations are met, and projects progress seamlessly.

• One Project Manager
• SME Collaboration
• Governance Structure
• Escalation Pathway
• Drug Substance to Fill & Finish
• Technical Transfer
• Analytical Alignment
• Joint Project Management
• Integrated Timelines