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.

Quality Compliance

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

Utilizing advanced analytical techniques and adhering to stringent global regulatory standards, Bora Biologics offers a comprehensive stability program designed to ensure the efficacy, safety, and quality of products throughout their shelf life. Our stability study services encompass various conditions, including long-term, accelerated, and stress testing for both drug substances and drug products, along with in-use stability studies for clinical materials.
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.