Immuneel Therapeutics Private Limited and the BRIC-Translational Health Science and Technology Institute (THSTI) have officially entered into a Memorandum of Understanding (MoU), to establish a collaboration to qualify, establish, and manage a cutting-edge facility for the Current Good Manufacturing Practice (cGMP)-compliant manufacturing of CAR-T cell therapies and Lentiviral Vectors (LVVs).
Strategic Collaboration to Operationalize Clinical Pipelines
The partnership synergizes THSTI’s newly established small-footprint cleanroom facility with Immuneel’s validated commercial-grade cell therapy ecosystem and industrial operational expertise. The primary goal of this collaboration is to operationalize the facility, obtain necessary regulatory approvals from the Central Drugs Standard Control Organization (CDSCO), and successfully translate academic and industrial research pipelines into clinical realities.
The facility’s functional footprint operates with distinct allocations:
•Lentiviral Vector (LVV) Suite: running on a campaign mode to manufacture vector lots for Immuneel programs and generate clinical-grade vectors for academic and industry pipelines.
•CAR-T Manufacturing Suite: using time-block campaigns dedicated to pilot batches, closed processes, and semi-integrated processes.
•Quality Control (QC) Lab: maintaining continuous utility for analytics under unified standard operating procedures.
A Milestone in Industry-Academia Collaboration
The partnership synergizes THSTI’s newly established cleanroom facility with Immuneel’s validated commercial-grade cell therapy ecosystem. By uniting academic research capabilities with industrial operational expertise, the collaboration seeks to accelerate the translation of early-phase clinical pipelines into viable treatments for patients.
“Industry and academia collaborations are the need of the hour to bring out the best of India's scientific and translational capabilities. This partnership represents a vital step in operationalizing clinical pipelines, and it begins as one of the many such collaborations needed in India to ensure we can compete and lead on a global scale.” said Dr. Lakshmikanth Gandikota, Chief Scientific Officer, Immuneel Therapeutics.
Advancing India’s Global Competitiveness
Through this agreement, both parties will work toward obtaining necessary regulatory approvals from the Central Drugs Standard Control Organization (CDSCO). The joint effort aims to create a shared capacity manufacturing ecosystem that fosters innovation while enhancing India's self-reliance in advanced therapeutics.
“True innovation thrives when academic research leverages industrial rigour. This strategic alliance with Immuneel enables THSTI to operationalize clinical pipelines efficiently, ensuring that promising laboratory-developed constructs are rapidly translated into clinical realities for patients in India and beyond.” said, Prof. G Karthikeyan, Executive Director, THSTI.
“This collaboration bridges the critical gap between scientific discovery and clinical delivery. By partnering with an industry leader to manage our facility operations, we can efficiently navigate regulatory pathways and ensure our investigator-initiated academic studies have reliable access to clinical-grade materials.” added Dr. Amit Awasthi, Senior Professor, THSTI.
