Designed to expedite gene to GMP manufacturing for biotechs in as little as 9 months*
Shilpa Biologicals Ltd, a subsidiary of Shilpa Medicare Ltd, launches its new gene to GMP manufacturing platform, SB HiMax which will empower biotechs to take suitable monoclonal-antibody programmes from gene to GMP clinical supply in as little as nine months, and complex bispecific and trispecific antibodies in approximately 11 months.
The new service, launched at CPHI Milan, 6–8 October 2026, has been specifically created for biotechs seeking accelerated development timelines but struggling to find partners able to offer the necessary speed and flexibility. Unlike conventional cell-line development platforms, SB HiMax provides an integrated pathway from clone development and cell-bank creation through upstream and downstream process development, analytical-method development, GMP drug-substance manufacturing and drug-product filling. CMC development and regulatory support are embedded throughout, enabling customers to progress towards clinical studies without repeatedly transferring their programme between different providers.
“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.” Commented Uday Harle, CEO Shilpa Biologicals.
Significantly, SB HiMax, not only helps clients improve timelines but also improves yield, with the platform typically achieving >5 g/L, which is significantly above the industry average for 1–3 g/L for CHO fed-batch processes.
The service is available not just across monoclonal targets but is available to customers with ADCs, bioconjugates, microbial-expressed products and recombinant proteins.
SB HiMax accelerates development by running clone screening, process development and key CMC activities in parallel, supported by established platform processes and single-use GMP manufacturing. The platform scales to 2,000 L while maintaining critical quality attributes and less than 10% titre variation, helping customers establish a commercially viable process from the outset.
Harle added: “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.”
