Aurigene Pharmaceutical Services Scales New Heights in Bispecific Antibody Development

Aurigene is proud to announce a significant milestone in its biologics journey with the successful development, regulatory approval, and patient dosing of a bispecific antibody candidate — all achieved within a year. This success underscores Aurigene’s growing capabilities in the development and manufacturing of complex biological molecules.

The company’s state-of-the-art biologics facility supports end-to-end services from cell line development through clinical manufacturing. Aurigene’s expertise spans mAbs, recombinant proteins and bispecific formats, powered by advanced technologies such as N-1 perfusion for high-density cell cultures, optimized filtration, and purification strategies. Aurigene’s analytical development team combines cutting-edge HPLC, UPLC and Orbitrap LC-MS platforms with advanced mass spectrometry to deliver comprehensive characterization of biologics.

“We are truly excited about the progress we’ve made in bispecific antibody development. The speed and scientific rigor with which we moved from development to IND clearance and patient dosing is a testament to our integrated platform and talented teams,” said Akhil Ravi, CEO of Aurigene Pharmaceutical Services. “This is just the beginning — we are committed to expanding our work in the bi-specifics space and partnering with innovators globally to bring these next-gen therapeutics to patients faster.”

About Aurigene Pharmaceutical Services
Aurigene Pharmaceutical Services is a fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) serving the global biopharmaceutical industry. With over two decades of experience, Aurigene offers end-to-end solutions across the drug development lifecycle — from early discovery and preclinical development to clinical manufacturing and commercial supply.

In the biologics space, Aurigene has built a comprehensive platform to support the development and manufacturing of monoclonal antibodies (mAbs), recombinant proteins, bispecific & multi-specific antibodies. We assess critical quality attributes—identity, purity, potency and stability—through integrated bioanalytical and physicochemical workflows, ensuring even low-level variants are detected. Our in-house platform methods for monoclonal antibodies and related formats accelerate process development, method development, qualification, and IND-enabling submissions. With rapid turnaround and regulatory-grade data, Aurigene helps the innovators to de-risk programs and fast-track development with utmost reliability & flexibility.