Science that stands up to regulatory scrutiny.

Lead Programme

Nivolumab biosimilar — Development & Production of Oncology Monoclonal Antibody Drugs.

Delivered by PTC Oncology in partnership with The Antibody Company (TAC), this programme covers the three critical steps required to bring a monoclonal antibody biosimilar to market:

1. 01

   Cell line for oncology mAb production

   Cell culture process development starts with cell line generation and selection, followed by media and process optimisation across shaker flasks, bench-scale bioreactors and pilot systems — producing material for preclinical toxicology and clinical manufacture under cGMP.

2. 02

   Formulation & manufacturing process development

   Parenteral IV formulations pre-formulated and formulated to high technical standards, engineered for stability, efficacy and safe administration to cancer patients.

3. 03

   Analytical method development & validation

   Methods supporting characterisation, identification and determination of starting materials, in-process controls and final drug product specifications — from early R&D through commercial manufacture.