Hikal inaugurates HPAPI Lab at its Pune Innovation Centre

New Delhi: Hikal Ltd., the preferred long-term partner for leading global life sciences companies, has announced the inauguration of its state-of-the-art High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at its Integrated Innovation Centre in Pune.

This world-class facility marks a significant milestone in Hikal’s innovation journey, further strengthening its end-to-end CDMO capabilities and enhancing its ability to safely develop and test and deliver highly potent compounds for the global pharmaceutical industry.

The new cGMP-compliant HPAPI Laboratory is equipped with state-of-the-art isolators designed to meet Occupational Exposure Band 5 (OEB-5) requirements. The lab is purpose-built to support the development of complex oncology and specialty molecules, including components of Antibody Drug Conjugates (ADCs), Peptide Drug Conjugates (PDCs), and Proteolysis Targeting Chimeras (PROTACs).

“Our new HPAPI laboratory represents a critical step forward in expanding our capabilities and reinforcing our unwavering commitment to innovation, safety and customer excellence,” said Sameer Hiremath, Vice Chairman & Managing Director, Hikal Ltd. “With this new addition to our technology toolbox, we are well positioned to meet the growing demand for potent molecule development while maintaining the highest global standards of containment and compliance.”

The facility has been designed with a range of advanced features to ensure both safety and efficiency. It incorporates segregated entry and exit points for personnel and materials, allowing for secure operations. A complete sequence control system manages every step from raw material dispensing to final packing within isolators. Built-in milling operations enable precise particle size control during development, while advanced analytical capabilities such as HPLC and GC support in-lab testing of HPAPIs, minimizing the risk of cross-contamination. To further safeguard operations, the facility is equipped with stringent containment systems that maintain exposure control up to OEB 5, validated through independent third-party surrogate testing.

The HPAPI Lab complements Hikal’s existing validation lab, process safety lab, solid state lab, flow chemistry lab, instrumentation and synthesis laboratories, creating a truly integrated innovation ecosystem at the Pune site. This ecosystem supports the seamless transition of projects, from early-phase studies to commercial manufacturing, covering scales from milligrams to >100 Kg batch size in our pilot plant.

With decades of experience in scaling molecules from clinical to commercial, Hikal continues to be a trusted partner for the pharmaceutical, animal health, and specialty chemicals industries, enabling the development and manufacture of APIs and AIs through innovation, flexibility, and best in class ESG.