Quality Management
Quality – the foundation of Bora Biologics
Millions of patients worldwide rely on the safe and consistent production of biopharmaceutical medicines. At Bora Biologics, our unwavering commitment, expertise, and experience ensure the quality of every step, from transfection to the release of each new batch. With a steadfast dedication to robust quality control and reliable supply, we prioritize the safety and efficacy of the medicines we deliver to our partners.
Read the article “Strategies and tactics for success in biologics analytical testing” to explore the importance of well-designed analytical testing throughout biopharmaceutical development, emphasizing strategies for success in meeting regulatory requirements and optimizing processes.
Unwavering excellence to quality and compliance
Bora Biologics upholds a world-class quality system rooted in extensive industry experience and strict adherence to global compliance standards. Our dedicated quality unit maintains the highest levels of quality assurance, exemplified by our swift GMP re-certification from the Taiwan FDA in under 2.5 months. We ensure continuous improvement and adherence to the highest industry standards by leveraging modern quality management tools including facility monitoring, electronic document management, and SAP integration best practices.
Bora’s advanced stability program safeguards efficacy and safety
Robust biologics capabilities designed to accommodate biopharma’s unique needs
Our solutions for biologics include analytics and formulations development, cell-line and process development, and full cGMP manufacturing services.