Bharat Biotech Establishes Nucelion Therapeutics for Cell and Gene Therapy Manufacturing

Bharat Biotech has established Nucelion Therapeutics, a new wholly owned subsidiary operating as a Contract Research Development and Manufacturing Organisation (CRDMO). Located in Genome Valley, Nucelion Therapeutics is dedicated to supporting global life science innovators by providing high-quality, scalable process development and manufacturing solutions for advanced therapies. These therapies are intended for complex conditions such as cancers, autoimmune disorders, and rare genetic diseases.

Krishna Ella, Non-Executive Director of Nucelion Therapeutics, stated that the company's vision is to integrate advanced therapy platforms into India's healthcare ecosystem, aiming to create equitable solutions for challenging and rare diseases, emphasizing the future growth of pharmaceutical innovation in biologicals.

Raghu Malapaka, Chief Business Officer, highlighted that Nucelion will offer comprehensive, end-to-end services. This includes support from early-stage clinical development through to commercial-scale manufacturing, ensuring strict adherence to global regulatory standards set by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company has commissioned a Good Manufacturing Practice (GMP) facility capable of developing and manufacturing critical components such as plasmid DNA, viral and non-viral vectors, cell therapies, and performing aseptic fill and finish operations.

Nucelion Therapeutics will operate with its own independent leadership, governance, and information systems, engaging with all sponsors, including Bharat Biotech, on commercial terms at arm's length. The company is actively recruiting scientific and operational talent with global experience in cell and gene therapy execution.

Impact: This strategic move by Bharat Biotech significantly bolsters India's capabilities in the advanced biopharmaceutical sector, particularly in the high-growth area of cell and gene therapies. It positions India as a potential global hub for manufacturing these cutting-edge treatments, attracting international investment and talent, and potentially leading to the development of more accessible treatments for complex diseases within India and globally. Rating: 8/10

Difficult Terms: * CRDMO (Contract Research Development and Manufacturing Organisation): A company that provides services to pharmaceutical and biotechnology companies, including research, development, and manufacturing of drugs and therapies under contract. * Cell and Gene Therapies (CGTs): Advanced medical treatments that use cells or genes to treat diseases. This can involve modifying a patient's cells, using donor cells, or delivering genetic material to correct defects. * Genome Valley: A prominent life sciences cluster located in Hyderabad, India, hosting numerous research institutions and companies in the pharmaceutical and biotechnology sectors. * GMP (Good Manufacturing Practice): A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. * FDA (U.S. Food and Drug Administration): The federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. * EMA (European Medicines Agency): An agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. * Plasmid DNA: A small, circular molecule of DNA found in bacteria and some other single-celled organisms that is separate from the organism's chromosomal DNA. In biotechnology, it is often used as a vector to carry genes into cells. * Viral Vectors: Viruses that have been genetically altered so they can deliver genetic material into cells. They are often used in gene therapy to deliver therapeutic genes. * Autologous Cell Therapies: Therapies where a patient's own cells are collected, modified, and then reinfused back into the patient. * Allogeneic Cell Therapies: Therapies where cells are collected from a healthy donor and then given to a patient. * Aseptic Fill & Finish: A critical step in pharmaceutical manufacturing where sterile drug products are filled into their final containers (like vials or syringes) under sterile conditions to prevent contamination.