Leveraging Platform Analytical Methods to De-Risk Tech Transfer, Accelerate Timelines, & Ensure Global Supply Chain Flexibility for ADCs
- Establish and deploy a robust platform of core analytical method to standardize procedures and reduce the need for method re-development, accelerating the transfer of analytics to new internal and external manufacturing sites
- Co-develop unambiguous method instructions with QC and CMO partners to eliminate variability introduced by differences in interpretation or execution, ensuring robust assay performance
- Design the analytical control strategy around a pre-qualified platform from the outset to build flexibility and resilience into the supply chain, enabling faster and more robust tech transfers for global product roll-outs