CMC Support: Cell and Gene Therapy CRO Services

Detailed Chemistry, Manufacturing & Control (CMC) information submission is a critical part of your IND-submission irrespective of the class of therapeutic under investigation in order to validate the identity, purity, potency, viability, titers, potency, cell dose of your drug candidate. ASC offers expert CMC consultation and assay support for your investigational biotherapeutic: from potency analysis at DNA/ RNA/ protein levels, titration, cGMP cell line characterization for cell therapies, we offer you a support and resources to navigate the guidelines provided by the FDA or other regulatory authorities to enable regulatory compliance.