Contract research, development and manufacturing organisation (CRDMO) Aurigene Pharmaceutical Services has opened a 70,000 sq ft biologics facility in Genome Valley, near here, that will offer process development and clinical scale manufacturing capabilities.
It is designed to serve customers with process and analytical development and small scale manufacturing of antibodies and other recombinant proteins for preclinical and early phase clinical requirements. While the process and analytical development laboratories are operational, the commissioning of manufacturing capacity will be completed by 2024, the Dr. Reddy’s company said in a release.
“The state-of-the-art facility will enable us to service our global customers efficiently and support in the development of innovative medicine,” Aurigene CEO Akhil Ravi said.
The facility is equipped with best-in-class equipment and control systems, supported by an experienced talent pool to ensure seamless transfer to large-scale commercial CGMP manufacturing facilities. The new facility is complementary to the company’s current discovery capabilities and infrastructure, which primarily focuses on recombinant proteins including mAbs, bi- and multi-specifics, immune-fusion molecules, antibody drug conjugates and other complex proteins, the company said.
The newly facility will deliver robust, compliant and economically viable cell lines, process development solutions and supporting analytical methods in support of customers seeking to rapidly enter and progress through clinical development.
“Our new facility further strengthens Aurigene’s capabilities… as companies from start-up biotechs to global multinationals strengthen their supply chains and seek economically viable support for both their development portfolios and marketed products,” Global Commercial Head – Biologics Roger Lias said.
In a filing recently, Dr. Reddy’s said it has invested in the equity shares of Aurigene Oncology, which in turn will make similar investment in equity shares of Aurigene Pharmaceutical Services, which is a wholly-owned subsidiary of AOL and a step-down wholly-owned subsidiary of Dr. Reddy’s. “We further inform AOL has made an investment of ₹649,99,99,520 in APSL and APSL has allotted 11,60,71,420 equity shares of ₹10 each at a premium of ₹46 per share to AOL on May 30.
