Consultant of Cell Therapy Product Development

Cell therapy products differ from traditional small molecule or biologic drugs in product quality, preclinical testing, and clinical trial design. For example, in terms of product quality, Drug Substance testing may sometimes be exempted. Preclinical trials need to consider the existence of off-target toxicity. Clinical trial designs may require safety monitoring for up to a year. Moreover, these aspects often vary from product to product.
With professional consultants’ assistance, it is believed that your company can significantly reduce development time, costs, and risks.