As biotech companies look to realize the full potential of bispecific drug candidate and make it market-ready, it is essential to find appropriate expression technologies and development processes that can accelerate their path to clinic and support a smooth and scalable manufacturing process.
Building on a decade of experience, we have created and optimized a workflow with platform, processes and analytics using a solid risk-based approach to track activities in parallel during the DNA-to-IND process, enabling reduction of timelines without increasing risk.
This integrated drug substance and drug product approach enables us to take your bispecific antibody from DNA to IND in only 13 months*. If you are looking to obtain comprehensive information on your drug candidate as early as possible, we deliver tox drug substance in only 7 months* so that you can perform toxicological studies before entering GMP manufacturing.
*From DNA transfection. Subject to terms and conditions.
We use pre-defined project gates and technical forums to manage successful CMC programs and proactively identify and mitigate technical risks as soon as possible.
Project gates are pre-defined based on our experience and drive a cross-functional, data driven approach for our customer’s project.
Risk levels can be tailored based on customer timeline requirements and tolerances.
Our experienced Senior Technical Leads in the UK and west coast US as well as our Drug Product Technical Experts in Switzerland are available to support proposals and project teams with in-depth technical and CMC knowledge for drug substance and drug product.