Advisory & CMC strategy
Program and CMC roadmaps for mAbs and recombinant proteins, including risk assessment, study design, and USDA 9CFR–aligned experimental planning and reporting.
ArtProtein partners with emerging and mid-size biotechs to design, express, and develop antibodies and recombinant proteins using stable and transient CHO/HEK platforms.
Our team brings more than 20 years of experience in biologics R&D, process development, CMC documentation, and USDA 9CFR–related studies.
Program and CMC roadmaps for mAbs and recombinant proteins, including risk assessment, study design, and USDA 9CFR–aligned experimental planning and reporting.
Stable and transient CHO/HEK expression, scale-down models through to process-controlled bioreactors, and DoE-driven upstream and purification concepts.
Fit-for-purpose development data, CMC summaries, and USDA 9CFR proposal and report support to help you communicate clearly with regulators and partner CDMOs.