Bengaluru, Jan 18 (IANS) Immuneel Therapeutics Ltd, co-founded by Biocon chairperson Kiran Mazumdar-Shaw, unveiled its integrated cell-and-gene therapy development and manufacturing facility at Narayana Hrudayalaya Health City on the outskirts of this tech city on Monday.
“The research-led integrated facility has a hi-tech lab, CGMP-complaint manufacturing suites for cell and gene therapies to treat cancer patients from across the country,” said the city-based company in a statement here.
The Current Good Manufacturing Practices (CGMP) are required to conform to the guidelines recommended by agencies that control authorisation and licensing of the manufacture and sale of pharmaceutical products, dietary supplements and medical devices.
The facility is compliant with Indian Gene Therapy Product (GTP) guidelines released in 2019 and global CGMP guidelines for advanced therapy medicinal products (ATMP).
“The facility develops advanced technologies and provides affordable therapy that fulfills the government’s Atmanirbhar Bharat (self-reliant India) flagship programme,” said Biotechnology Department Secretary Renu Swarup on the occasion.
Immuneel is keen to play a key role in capability and capacity-building for the country in partnership with the biotechnology department and build an eco-system to deliver translational cell and gene therapy, said Mazumdar-Shaw.
“Immuneel has created an edifice to save precious lives using transformative therapies like CAR-T cell therapies,” said Narayana Health chairman Devi Shetty in the statement.
Chimeric Antigen Receptor-T cells are T cells that are genetically engineered to produce an artificial T-cell receptor for use in immunotherapy.
The multi-product, multi-process facility will focus on autologous cell therapies, including CAR-T cell therapy for lymphomas and leukemias (haeme malignancies) and other forms of solid tumors, allogeneic cell therapy and beyond cell therapy and oncology in future.
