A growing number of cell and gene therapies or ATMPs are entering development. Like other therapeutics they need to be clinically developed with data gathered on pharmacokinetics, immunogenicity and potency to satisfy regulatory safety expectations. However, unlike biopharmaceuticals, ATMPs are a very different challenge and a new way of thinking is required.
This training course will provide you with a deep dive insight into how cell and gene therapy products are clinically developed and manufactured. Once completed you will be aware of the types of assays needed to assess pharmacokinetics, immunogenicity and potency. You will also examine the regulatory expectations around assay validation.