Shilpa Biologicals, a full-service Contract Development and Manufacturing Organization (CDMO), has inaugurated a dedicated bioconjugation suite at its Dharwad facility in Karnataka, India. The new manufacturing site, announced on May 22, 2025, significantly enhances the company's capabilities in developing and producing antibody-drug conjugates (ADCs) and other advanced bioconjugate therapies.
The state-of-the-art facility is currently undergoing validation and is expected to begin onboarding client programs by September 2025. It features 200L single-use bioconjugation reactors and a substantial lyophilization capacity of up to 65 kg, making it well-equipped to handle commercial-scale production.
Dr. Sridevi Khambhampaty, Chief Executive Officer of Shilpa Biologicals, emphasized the strategic importance of this expansion: "Our co-located ADC services — spanning payloads, linkers, antibodies, and bioconjugation — are generating significant industry interest, especially from US and European biotech companies seeking a single, reliable partner to support their journey from discovery to commercial launch."
Comprehensive ADC Development Capabilities
The new bioconjugation suite is strategically located adjacent to the company's existing commercial biologics manufacturing facility in Dharwad. This proximity creates an integrated ecosystem for ADC development and production, streamlining the manufacturing process and potentially reducing timelines for clients.
Complementing the production facilities, Shilpa has established development laboratories that provide comprehensive services including process development, analytical characterization, and both early and late-stage scale-up capabilities. For final dose requirements, the company's Hyderabad site is equipped with multiple isolator-based fill-finish lines specifically dedicated to cytotoxic products.
Madhav Bhutada, director at Shilpa Biologicals, described the facility as "a strategic milestone for Shilpa Biologicals and for the Indian biopharmaceutical industry," adding that it "allows us to offer fully integrated ADC development and manufacturing services, supporting our mission to deliver innovative, high-quality therapies to patients worldwide."
Meeting Growing Demand for Advanced Cancer Therapies
This expansion positions Shilpa Biologicals among a select group of global CDMOs capable of providing clinical and commercial-scale manufacturing across all three core antibody-drug conjugate components: payloads, linkers, and antibodies, in addition to the critical bioconjugation process.
Industry experts note that the demand for ADCs and bioconjugate therapies is rapidly increasing, driven by their ability to deliver potent treatments directly to cancer cells while minimizing side effects on healthy tissue. ADCs represent one of the fastest-growing segments in oncology drug development, combining the targeting precision of monoclonal antibodies with the cell-killing power of cytotoxic payloads.
By investing in specialized manufacturing infrastructure, Shilpa Biologicals is positioning itself to play a key role in the global supply chain for these innovative therapies, while simultaneously reinforcing India's growing reputation as a hub for advanced biopharmaceutical manufacturing.
Strengthening India's Biopharma Manufacturing Sector
The new bioconjugation facility marks a significant advancement for India's biopharmaceutical manufacturing capabilities. As global pharmaceutical companies increasingly seek partners with end-to-end development and manufacturing expertise, Shilpa's expanded capabilities enhance the country's competitive position in the high-value biologics sector.
The Dharwad site has already established a reputation for advanced biologics manufacturing and has recently secured strategic partnerships and regulatory milestones. With this latest expansion, Shilpa Biologicals continues to strengthen its footprint in the biologics and biosimilars space, potentially accelerating the development of next-generation cancer therapies both for its own pipeline and for international clients.
