From Cell Line Development
to Commercial Manufacturing

Process Development

Scientific and technical advances remained an important part of platform development. N-1 perfusion capability was demonstrated at process development lab scale, marking progress in upstream process innovation and paving the way for improved manufacturing efficiency and scale-up, with approval secured for large-scale demonstration.

Development toolkits and process methodologies were advanced to improve cost competitiveness and reduce development timelines for complex biologics and novel modalities. These efforts reinforced the foundation of a more integrated and globally-aligned biologics CDMO platform.

Our cost leadership initiatives delivered a 10% reduction in COGS (Cost of Goods Sold) through the use of alternate resins and filters. We are on track to reduce it further by another 40% through new technologies and alternate media and consumables.

We successfully developed, scaled up and supported the IND filing of a very complex bispecific for an advanced market. We also developed two biosimilar molecules from cell-line development and technology transfer for clinical production.

In addition, we have commercially produced ATMP products such as mRNA and are manufacturing-ready for pDNA, which are the building blocks of cell and gene therapy. We have also developed an ADC with a cytotoxic payload and are progressing well toward scale-up, demonstrating our robust cGMP manufacturing capabilities for these complex modalities.

Unit 3 and Integrated Bioconjugation Capabilities, Bengaluru

Unit 3 marks an important addition to our biologics network, with successful operationalization and local regulatory approvals during the year supporting its transition into a live multi-product manufacturing asset. Built on advanced single-use technology, the facility enhances our ability to support clinical and commercial programs with greater flexibility, speed and manufacturing agility.

The year also saw the initiation of a dedicated non-clinical and clinical bioconjugation facility at Unit 3, expanding our ability to offer more integrated ADC and bioconjugation services. The suite is expected to accelerate development timelines by enabling both monoclonal antibody production and GMP bioconjugation at a single site, while complementing our existing commercial capabilities in payload and linker manufacturing.

Bayview Biologics Facility, USA

Bayview represents an important step in expanding our biologics footprint into the United States, broadening our ability to serve customers through a more globally distributed manufacturing network. During the year, the site progressed from an acquired asset to an operationally ready facility, with core infrastructure, systems and teams established to support future manufacturing-readiness.

Integration work during the year focused on aligning Bayview with our broader biologics platform across process, technology and quality systems, supporting seamless tech transfer and consistent delivery across India and the USA. Once fully integrated, the site is expected to expand our global single-use bioreactor capacity to 50,000 L, supporting delivery across India and North America.

Bayview adds 2 kL and 4 kL single-use bioreactor capacity across three value streams, including smaller-scale process tech transfer capabilities. Its single-use technology offers greater flexibility, faster changeovers and lower risk of lot-to-lot contamination. Bayview’s application to the FDA pre-check program reflected a proactive approach to regulatory preparedness and site credibility, while its selection as a Founding Partner of BioHub Maryland further increased its visibility within the regional life sciences ecosystem.