Shilpa Biologicals, a subsidiary of Shilpa Medicare, has launched SB HiMax, a new gene-to-GMP manufacturing platform designed to help biotechs accelerate biologics development and reach clinical supply faster.

 

The platform aims to take suitable monoclonal-antibody programmes from gene to GMP clinical supply in as little as nine months, while complex bispecific and trispecific antibodies could reach GMP supply in approximately 11 months.

 

SB HiMax helps biotechs facing compressed development timelines but struggling to find partners with the speed and flexibility needed to move programmes rapidly from discovery towards the clinic.

 

Unlike conventional cell-line development platforms, SB HiMax integrates the development 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 also built into the platform, allowing customers to progress towards clinical studies without repeatedly moving their programmes 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.

 

The platform is also targeting higher manufacturing yields. SB HiMax typically achieves more than 5 g/L, compared with an industry average of around 1–3 g/L for CHO fed-batch processes, according to the company.

 

The service extends beyond monoclonal antibodies to programmes involving ADCs, bioconjugates, microbial-expressed products and recombinant proteins.

 

SB HiMax is designed to compress development timelines by running clone screening, process development and key CMC activities in parallel. The approach combines established platform processes with single-use GMP manufacturing and can scale to 2,000 L, while maintaining critical quality attributes and less than 10% titre variation.

 

The company said the approach is intended to help customers establish a commercially viable manufacturing process from the outset, rather than having to redesign or transfer processes later in development.

 

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.”

 

The launch positions SB HiMax as an integrated development-to-manufacturing offering for biotechs seeking to shorten the path from genetic construct to clinical-ready biologics supply.