One-stop process-development platform from DNA to IND

As a trusted partner, we support drug-substance process development, drug-product process development, GMP manufacturing for clinical and commercial products, and the documentation and review process.

Process development and pilot manufacturing platform

● Science-based technology-transfer strategies

● Targeted bioanalytical-method development

● Industry-focused CMC and regulatory support

● Integrated formulation and drug-product development

● Advanced downstream purification-process development

● High-expression cell-culture process development

● Commercially sourced high-expression stable cell lines