Hikal, a long-term partner to global life sciences companies, announced the inauguration of its High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at its Integrated Innovation Centre in Pune.
The cGMP-compliant HPAPI Laboratory is equipped with isolators designed to meet Occupational Exposure Band 5 (OEB-5) requirements. The facility is intended 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 features segregated entry and exit for personnel and materials to ensure safe operations. It enables complete sequence control from raw material dispensing to final packing within isolators. Built-in milling operations are included to meet precise particle size requirements during development. The lab also has advanced analytical systems such as HPLC and GC for in-lab analysis of HPAPIs, designed to prevent cross-contamination. The containment systems maintain exposure control 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, forming an integrated innovation ecosystem at the Pune site. This setup allows for smooth project transitions from early-phase studies to commercial manufacturing, covering scales from milligrams to over 100 kilograms in the pilot plant.