Predictive and representative | optimal manufacturing | GMP experience | FDA and ICH guidance | lab model build and transfer | MSAT lab options
Developing a bioprocess scale-down model is at the core of your development and validation activities. A non-predictive scale-down model has severe consequences including unexpected changes to quality attributes during scale-up and suboptimal manufacturing performance.
We use our deep engineering and modeling expertise to develop, optimize and characterize bioprocesses in the lab that accurately predict performance at scale. Our process development experts, steeped in GMP manufacturing experience, follow the relevant FDA and ICH guidelines for developing scale-down models, and collaborate closely with you and your equipment suppliers to ensure better models are developed faster.
We partner with you to build one-off scale-down models but also have the expertise to run complete MSAT operations for your organization at a single location running multiple scale-down models simultaneously and supporting GMP production, troubleshooting and optimization across the lifecycle of your product.