Shilpa Biologicals has launched SB HiMax, a new gene-to-GMP manufacturing platform designed to accelerate the development of biologics for biotech companies.
The platform will be unveiled at CPHI Milan and 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 around 11 months.
Accelerating development through an integrated platform
SB HiMax integrates clone development and cell-bank creation with upstream and downstream process development, analytical method development, GMP drug-substance manufacturing and drug-product filling.
CMC development and regulatory support are incorporated throughout the programme, reducing the need for technology transfers between multiple providers.
According to Shilpa Biologicals, the platform can also support ADCs, bioconjugates, microbial-expressed products and recombinant proteins.
The company added that SB HiMax runs clone screening, process development and key CMC activities in parallel, using established platform processes and single-use manufacturing.
It can scale to 2000 L, with the company targeting less than 10% titre variation while maintaining critical quality attributes.
Shilpa Biologicals also claims typical titres of more than 5 g/L through the platform, compared with what it describes as an industry average of 1-3 g/L for CHO fed-batch processes.
Expanding end-to-end biologics capabilities
The launch adds to Shilpa Biologicals' growing portfolio of integrated biologics CDMO capabilities.
In June, the company launched PartnerPower, a digital platform designed to give customers real-time visibility across biologics R&D, analytical development and GMP manufacturing.
The company said the platform links operational data across these stages to support collaboration, decision-making and technology transfer, while providing continuous audit-ready transparency.
The following month, Shilpa Biologicals announced the commissioning of an integrated ADC drug-substance GMP manufacturing facility in India.
The facility brings together payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation and purification of GMP-scale drug substance.
Shilpa said the facility builds on the wider group's more than 25 years of experience in high-potency compound manufacturing and is being developed to meet requirements from regulators including the US FDA and EMA.
Together, these developments point to Shilpa Biologicals' broader strategy of providing integrated development and manufacturing services for complex biologics, rather than limiting its offering to individual stages of the CMC process.
Shilpa Biologicals CEO Uday Harle said SB HiMax was developed to address the challenge of moving biotech programmes into Phase I while establishing an economical manufacturing process.
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."
The company said the platform is designed to adapt its development approach to individual molecules rather than applying a single standardised process across programmes.
