Miltenyi Biotec weighs local CGT manufacturing, eyes export potential

German biotech firm explores hospital-linked cell and gene therapy manufacturing in India while assessing long-term opportunities in regional CGT production, training and exports

German-based Miltenyi Biotec, a global provider of products and services, is evaluating local manufacturing of cell and gene therapies in India, including CAR-T treatments, a move that could eventually position the country as a regional hub for cell and gene therapies (CGT) manufacturing, training and exports.

 

Speaking during a recent interaction, Stefan Miltenyi, Founder and Stakeholder, said the company’s immediate focus in India is on establishing hospital-linked manufacturing to meet domestic clinical needs, while longer-term possibilities include producing components and tools in India for supply to other markets.

 

“Cellular therapy is very different from classical pharmaceuticals,” Miltenyi said, noting that cells “do not like to travel well.” As a result, the company is prioritising local, point-of-care manufacturing models in collaboration with hospitals, while also keeping open the option of setting up central facilities in the future. 

The company said it is currently in discussions with hospitals and partners in India to enable local manufacturing of cellular products. While Miltenyi Biotec plans to manufacture its own products using its systems, it will work with partner hospitals and hospital chains to scale access.

 

India has become a strategic focus for the company over the past year, driven by clinical demand and the availability of scientific talent. Miltenyi Biotec has built a local team of more than 30 people within a year and has also set up training capabilities to address skill gaps in CGT manufacturing.

 

On the clinical side, Miltenyi Biotec said it is working to secure regulatory approvals for its therapies in India. Some clinical trials are being set up in the country, including a planned phase-2 trial for CD19, (an investigating CAR-T cell therapies for relapsed/refractory B-cell leukemia, lymphoma, and autoimmune diseases like lupus) following an earlier phase-1 study. The company said future indication trials are also expected to involve India.

 

Beyond oncology, Miltenyi Biotec highlighted interest in autoimmune diseases, rare diseases and conditions such as thalassaemia, where unmet medical need is significant in India. The company said it aims to introduce newer CGT indications in India without long delays compared to global markets.

 

Regionally, Miltenyi Biotec is conducting or planning clinical trials across Vietnam, Indonesia, Thailand, Taiwan and Japan. Over time, the company said India could play a broader role in supporting CGT manufacturing, training and potentially exports for emerging Asian markets, subject to regulatory clearances and quality requirements.

 

“Quality is extremely important for us,” Miltenyi said, adding that any expansion of manufacturing, particularly for components and tools, would require time and careful execution to ensure global standards are maintained.

 

While the company has not disclosed specific investment figures for India, it said initial investments have already been made to build teams, training infrastructure and trial capabilities. Further investments would be guided by clinical progress, regulatory approvals and the ability of local operations to become self-sustaining.

 

Miltenyi Biotec said India represents a long-term opportunity, driven not by supply-chain diversification strategies but by population size, clinical need and the potential to deliver advanced therapies locally.