Hyderabad-based Nucelion Therapeutics, a cell and gene therapy contract development and manufacturing organisation (CDMO) and wholly owned subsidiary of Bharat Biotech, and Bengaluru-headquartered Pandorum Technologies, a tissue engineering and regenerative medicine company, have announced a manufacturing partnership to advance two PRIP-backed ophthalmology projects focused on developing investigational therapies for advanced keratopathy and wet age-related macular degeneration (wet AMD).
Pandorum is developing cell-free regenerative medicines based on designer exosomes that carry biological signals involved in communication between cells. The biological activity of these exosomes is tuned to address inflammation, fibrosis and vascular pathology while supporting tissue repair. The platform connects the manufacturing process, the product, its biological activities and the corresponding tissue response in an integrated learning loop.
Through its collaboration with Nucelion, Pandorum is connecting programmable regenerative medicine design with reproducible manufacturing and indication-specific development, while building this capability in India with national research support.
Nucelion’s role in the two investigational ophthalmology projects will centre on process development and manufacturing support for Pandorum’s designer exosomes, aligned with the requirements and development stage of each programme. The partnership reflects the role specialised manufacturing capabilities can play in the development of emerging regenerative medicines.
The broader Pandorum–Nucelion collaboration is intended to provide material manufactured under Good Manufacturing Practice (GMP) for clinical studies in India and abroad, subject to applicable regulatory approvals.
Pandorum’s advanced-keratopathy programme is directed towards clinical evaluation of investigational therapies for severe corneal disease. The wet-AMD programme extends the platform into retinal disease, with the current project focused on preclinical development and preparation for subsequent clinical translation. Each programme will advance according to its own evidence, milestones and regulatory requirements.
The two projects reflect the potential of India’s research and manufacturing ecosystem to advance approaches to treating eye diseases.
The projects have a combined planned outlay of ₹16.97 crore, comprising up to ₹8 crore in funding under the PRIP scheme.
“Advanced therapies require process development, analytical methods and manufacturing discipline to progress together. Our role is to help translate Pandorum’s product requirements into reproducible processes and development-stage manufacturing, with quality built into the work from the outset. This collaboration brings complementary capabilities together to advance complex biologics within India’s growing advanced-therapies ecosystem,” said Dr Raghu Malapaka, Chief Business Officer, Nucelion Therapeutics.