#China #Suzhou #GMP Certification #EMA #Altruist Biologics

Altruist Biologics Secures EMA GMP Certification

Altruist Biologics, a prominent player in the contract development and manufacturing sector, proudly announces that its manufacturing site in Suzhou, China, has successfully obtained Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA). This significant milestone, achieved with zero critical findings during the inspection, marks the facility's debut in receiving such prestigious certification and enhances its capabilities for product distribution in the European market.

The EMA's rigorous inspection process endorsed the Suzhou facility as part of a marketing authorization application for a biologics product by a leading biopharmaceutical partner. The certification process encompassed a thorough evaluation of the entire biologics manufacturing lifecycle, including a detailed examination of quality systems and overall operational performance within the site. The EMA recognized the site's extensive quality management systems, infrastructure, technical expertise, data integrity controls, and managerial effectiveness, demonstrating Altruist's commitment to quality across all levels of production.

Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, commented, “Quality is fundamental throughout the biologics lifecycle. Meeting strict regulatory requirements from development through to commercialization is vital for innovative drug companies. As they navigate complex cross-border regulations and increasing needs for capacity, Altruist is dedicated to providing pathways to meet those challenges with the utmost global standards. This EMA GMP certification reflects our capability to meet these demands while ensuring our manufacturing processes align with the needs of our global partners and the patients they serve.”

Altruist’s Suzhou and Hangzhou facilities are structured to comply with a wide range of regulatory requirements from different authority bodies, including the EMA, U.S. Food and Drug Administration (FDA), Japan’s Pharmaceutical and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA). The Suzhou site is equipped with an impressive 60,000 liters of manufacturing capacity designated for the production of antibodies, along with an antibody-drug conjugate (ADC) clinical manufacturing line. Furthermore, the Hangzhou site is poised to expand its total capacity, currently offering 172,000 liters of antibody manufacturing, with additional facilities expected to go online soon to further bolster production.

Once all planned expansions are operational, Altruist’s combined production capacity will soar to 232,000 liters, propelling the company into the ranks of the top 10 global CDMOs based on manufacturing capabilities.

In addition to its EMA certification, the Suzhou facility has garnered a wealth of recognition from various global regulatory agencies. It has successfully completed a remote evaluation by the FDA and received approvals from both the NMPA and COFEPRIS in Mexico, as well as passing over 40 quality audits conducted by international clients, further solidifying its high standards for quality and compliance.

Buoyed by this recent certification, Altruist Biologics remains committed to delivering premier CDMO services to biotechnology and pharmaceutical enterprises worldwide. The company aims to facilitate the swift development of innovative therapies that diminish geographic and regulatory barriers, ultimately ensuring that patients have faster access to necessary medications.

About Altruist Biologics

Altruist Biologics operates as a leading contract development and manufacturing organization (CDMO), wholly owned by Innovent Biologics, Inc. (1801.HK). The company specializes in the development, clinical, and commercial manufacturing of a range of products such as antibodies, fusion proteins, recombinant proteins, and ADCs. Featuring cutting-edge cGMP facilities in Suzhou and Hangzhou, with a total production capacity of 232,000 liters, Altruist continues to invest in enhancing its capabilities to achieve operational excellence and quality safety. With a decade-long track record in bioprocessing, Altruist has played a critical role in commercializing over 20 drugs and completing upwards of 2,000 commercial batches, boasting an impressive success rate exceeding 99.8%. Having amassed over 100 global regulatory filings and successfully handling numerous inspections, Altruist is dedicated to aiding its clients in producing high-quality and affordable biopharmaceuticals for patients around the world.