In vivo comparability testing, when required, can be difficult to design and execute optimally. A cell therapy client hired DHC to design and outsource nonclinical efficacy and safety studies to demonstrate comparability of a changing clinical stage manufacturing process. This engagement combined two overlapping areas of DHC services: preclinical development and comparability studies.
By working with Dark Horse, the client received a clear vision of the nonclinical development path and comparability package needed to support the manufacturing process changes for their clinical stage drug product. Additionally, the client identified and forged relationships with the preclinical CROs best suited to support ongoing development of their cell therapy program.
