Shilpa Biologicals Ltd, a subsidiary of Shilpa Medicare Ltd, has launched SB HiMax™, a gene-to-GMP manufacturing platform that the company says will allow biotechs to take suitable monoclonal-antibody (mAb) programmes from gene to GMP clinical supply in as little as nine months. Complex bispecific and trispecific antibodies can reach the same point in approximately 11 months. The service was launched at CPHI Milan, 6-8 October 2026.

The service targets biotechs that need accelerated development timelines but struggle to find partners offering the necessary speed and flexibility. Unlike conventional cell-line development platforms, SB HiMax provides an integrated pathway covering:
• clone development and cell-bank creation;
• upstream and downstream process development;
• analytical-method development;
• GMP drug-substance manufacturing; and
• drug-product filling.

CMC development and regulatory support are embedded throughout, so customers can progress towards clinical studies without repeatedly transferring a programme between providers. The nine-month figure refers to conventional mAbs.

Parallel working, yield and scale

SB HiMax runs clone screening, process development and key CMC activities in parallel, supported by established platform processes and single-use GMP manufacturing. The platform typically achieves more than 5 g/L, against an industry average of 1-3 g/L for CHO fed-batch processes, according to the company. It scales to 2,000 L while maintaining critical quality attributes and less than 10% titre variation, which Shilpa says helps customers establish a commercially viable process from the outset.

The service is available for monoclonal targets and also for antibody-drug conjugates (ADCs), bioconjugates, microbial-expressed products and recombinant proteins.

Uday Harle, CEO of Shilpa Biologicals, commented: “We realised the two biggest issues facing biotechs are: how can they expedite the process of reaching Phase I studies, and can they get there with a cell line and process that are economical and high yielding? The challenge, of course, is that this type of solution requires a multipronged strategy, and large CDMOs are unlikely to be able to look so prescriptively at a solution. That is why we have created this new platform, enabling us to take a holistic approach so that biotechs can advance to studies more efficiently while saving precious time.”

Harle noted: “SB HiMax is another new service that embodies our customer promise – ‘your complex biologics to medicines’. To deliver on that promise, we looked at the typical CDMO journey and the challenges biotechs face in moving from discovery to development. So, it’s not a one-size-fits-all platform: it adapts to each customer’s specific target, using the combination best suited to advancing that specific molecule.”

About the company

Shilpa Biologicals is a wholly owned subsidiary of Shilpa Medicare Ltd, focused on the development and contract manufacturing of complex biologics and oncology biologicals, with capabilities spanning early development through GMP-scale drug-substance manufacturing. Its parent is a vertically integrated pharmaceutical company headquartered in Raichur, Karnataka, India.

For more information, visit: https://shilpabio.com/

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