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Stem cells to be a major branch of medical treatments & standard of cure: B N Manohar

Nandita Vijay, Bengaluru
Monday, February 20, 2023, 08:00 Hrs  [IST]

Stem cells would be a major branch of medical treatments and would be a standard of cure and practice in the years to come, said B N Manohar, MD & CEO, Stempeutics.

In India, the regulatory scenario for stem cells is evolving. CDSCO has established regulatory framework for cell or stem cell derived products, he added.

Globally US FDA guidelines are the gold standard for cell and gene therapy products and exports are easy. But we see the need for a dedicated regulatory framework in India on par with the global standards which will ensure our clinical trial data is acceptable. This will help to India design and develop stem cell products to the developed markets of US, EU and Japan. Even Bangladesh insists on a US FDA, PMDA and EMA approval, else additional clinical trials need to be conducted in that country to register the product, he said. 

India also needs approved US FDA kits and CLIA certified labs to diagnose communicable disease markers in donors for its cell banks. This will also help Indian biotech companies to create globally compliant cell banks, Manohar told Pharmabiz.

Manufacture of stem cells requires skilled manpower as the live cells are considered as drug. We need to focus on Master Cell Banks/Working Cell Banks, characterization of cell banks, product release criteria, product consistency, yield formulation, cryopreservation, stability and cold chain logistics. There is also a need for good in-process controls like osmolality, pH, color & turbidity, morphology, confluency, viability and purity. Each step of chemistry, manufacturing & controls (CMC) needs stringent monitoring to ensure batch to batch consistency for product integrity.

Even as small molecule development requires 10 years from R&D to commercialization and biologics takes about 12 years. Cell and gene therapy needs a longer time due to its complex product development and regulatory challenges. Stempeutics took about 14 years to bring the products to the current stage of commercialization, Manohar told Pharmabiz.

Our Stempeucel-CLI is marketed by Cipla under the brand name Regenacip and Stempeucel-OA product is marketed by Alkem Labs under the brand name StemOne. We are pacing up to create awareness among doctors and patients about our novel cell therapy products. The effort is to treat a many suitable patients in India and abroad. We are also working to create an eco-system bring these cell therapy products under insurance coverage, build cost effective cold chain logistics too, he said.

The Bengaluru-based Stempeutics is working two more new indications: Non healing diabetic foot ulcer and perianal fistula due to Crohn’s disease. Clinical trials are underway and the intent is market both in 2024 subject to successful clinical outcomes, said Manohar

The company’s cGMP manufacturing facility at Manipal in Dakshina Kannada district has a production capacity of 100 billion mesenchymal stromal cells per annum. Considering successful commercialization of products in India, Stempeutics with Kemwell Biopharma set up a new cell therapy GMP unit of 500 billion cell capacity with 2D technology where batch validation is on. Stempeutics operations will shift to this new facility in the next few months. Additional space of 23,500 sq. ft. is available for further expansion and the company is evaluating newer manufacturing technologies too

With the incidence of knee OA much higher compared to critical limb ischemia, Stempeutics is aiming to generate substantial revenue in the next 5 years.


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