Manufacturing, Access Key to Scaling Next-Gen Biologics, Say Experts

Hyderabad:Experts on Tuesday said manufacturing discipline, affordability and equitable access rather than scientific discovery will determine how quickly next-generation biologics reach patients.

Speaking at a panel discussion on Next-Gen Biologics and Advanced Modalities: From Discovery to Clinical Proof & CMC at Scale at BioAsia 2026, Gil Bashe, global chair of health at Finn Partners, said biologics account for over 40 per cent of the global pharmaceutical market, with more than 2,000 cell and gene therapies in development.

“The defining challenge before us is not invention. It is translation, clinical proof, CMC rigour, scalable manufacturing, affordability and global access,” he said.

The session brought together Dr Darrin Morrissey of NIBRT Ireland, Dr Sai Praveen Haranath of Apollo Health Axis, VSimpson Emmanuel of ImmunoACT, Dr José Castillo of Quantoom Biosciences and Dr Madhuri Vusirikala of Actinium Pharmaceuticals.

Dr Raches Ella highlighted India’s vaccine manufacturing strength, stating that one in three children globally receive a vaccine produced in India. “Our goal is to touch all 125 million children born each year,” he said, adding that the company is preparing multiple Phase III trials, including what he described as the world’s largest TB vaccine efficacy study.

On mRNA platforms, Dr José Castillo said decentralised production systems are being deployed across regions to build self-sufficiency. “At the end, we are supposed to make decisions based on science,” he said, stressing regulatory alignment and public confidence.

Focusing on cancer therapies, Dr Madhuri Vusirikala explained radioligand theranostics,which combine diagnostics and targeted radiation. “You are giving systemic radiation in a targeted manner,” she said, noting that alpha emitters limit damage to surrounding healthy tissue.

Simpson Emmanuel detailed progress in indigenous CAR-T therapy, describing it as a personalised treatment where a patient’s own T-cells are engineered and reinfused.

He said manufacturing innovations have reduced costs to less than one-tenth of global benchmarks and that more than 90 centres in India now have experience administering the therapy. “When we solve it in India, we can solve it for the world,” he said.

From a health systems perspective, Dr Sai Praveen Haranath said innovation must be accompanied by digital integration and remote care models to expand access. “The molecule is there, but it’s not reaching the patient because of systemic issues,” he observed.

Dr. Darrin Morrissey underscored that manufacturing consistency is central to delivery. “When it comes to applying new technologies and delivering them to the world, it all comes down to manufacturing,” he said, adding that skilled workforce development and standardized processes are critical for scaling advanced therapies.