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Drug development needs more integrated approach to science and manufacturing: Ashu Tandon
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Yash Ved, Mumbai
November 11 , 2026
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India has built significant strengths in pharmaceutical research, development, engineering and manufacturing. The next opportunity is to connect these capabilities more seamlessly across the drug-development lifecycle, creating greater continuity from development through scale-up and commercialisation, according to Ashu Tandon, EVP & chief commercial officer, Aragen Life Sciences.
Tandon added that the future of drug development will depend not only on discovering new therapies, but on creating more effective pathways to scale them and drug development needs more integrated approach to science and manufacturing. For global pharmaceutical and biotechnology companies, the value of a development and manufacturing partner is increasingly about more than capacity.
"Scientific innovation delivers its greatest value only when it can be translated into a process that is reproducible, scalable and capable of delivering consistent quality to patients. Achieving this requires an integrated approach that enables better-informed decisions, stronger process understanding, more efficient scale-up and greater confidence throughout the development lifecycle. The journey from molecule to scale should therefore no longer be viewed as a sequence of handovers. It should be an integrated pathway where scientific innovation, development expertise and manufacturing excellence evolve together from the earliest development decisions through to commercial production," Tandon said.
Tandon added, "Drug development is becoming more complex at a time when the need to bring new therapies to patients faster has never been greater. A promising molecule creates value only when it can be developed, scaled and manufactured reliably. As therapeutic modalities continue to evolve, bringing molecules from discovery to commercial production requires increasingly specialised development and manufacturing expertise. Yet the journey from discovery to commercial production is still often managed as a series of distinct stages, with different partners taking over at different points."
"This traditional model creates gaps where continuity matters most. A molecule that performs well in the laboratory can present very different challenges when it needs to be reproduced consistently, transferred between facilities or manufactured at scale. For small molecules, these may involve route selection, impurity profiles, raw materials or process safety. For biologics, the relationship is even more closely intertwined, with cell-line characteristics, upstream and downstream processes and critical quality attributes all influencing the final product," added Tandon.
For biologics, development and manufacturing are particularly interconnected because the process itself can influence the product. In a monoclonal antibody program, for example, cell-line characteristics, culture conditions and purification processes can influence critical quality attributes and ultimately affect product quality. Scaling up is therefore not simply about producing a larger volume; it requires maintaining control over the conditions that underpin consistent product characteristics.
The rapid development and scale-up of Covid-19 vaccines demonstrated the importance of this connection. Vaccine manufacturers had to scale complex biological processes while simultaneously establishing robust controls, analytical methods and manufacturing capacity. The experience reinforced a broader lesson: when process development and manufacturing are considered together, scale-up becomes an integral part of development rather than a final-stage challenge, he said.
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