BioDlink has been granted GMP certification by the National Administration of Drugs, Food and Medical Technology (ANMAT) of Argentina. 

This follows recent certifications in Brazil, Indonesia, Egypt, and Colombia.

The GMP inspection, conducted by ANMAT, focused on a commercial manufacturing facility in Suzhou, China, where biosimilar products are produced, including Pusintin (bevacizumab) injection. 

This inspection represents BioDlink’s facilities and processes were found to be in full compliance with the stringent GMP standards set by ANMAT. BioDlink’s Suzhou facility, which spans 50,000 square meters, is certified by regulatory authorities in multiple countries. 

Pusintin is a broad-spectrum anti-VEGF monoclonal antibody treating metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). Kexing BioPharm, the global licensee for Pusintin in emerging markets, collaborated with BioDlink to support this AVMAT inspection.

Currently, the Suzhou site operates with a combined bioreactor capacity of 20,000 liters for antibody drug substance, integrating advanced perfusion fed-batch technology to enable efficient and cost-effective antibody production. 

With an annual capacity of 300,000 liters of antibody drug substance, BioDlink is equipped to support the growing demand for mAb, BsAb, Antibody-drug Conjugate, and biosimilar manufacturing in global markets.

Dr. Jun Liu, CEO, and Executive Director of BioDlink commented, “This GMP certification from Argentina is a significant step in our global expansion strategy, underscoring BioDlink’s proven capabilities in reliable, scalable, and affordable biosimilars, especially antibody drugs, on a global scale. Our partnership with Kexing Biopharm is better positioned to serve the Latin American market and contribute to improving access to essential oncology treatments.”