Cell and Gene Therapy Bioassay – A Prerequisite for the ATMPs Development

Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. In fact, from year 2016 to 2020 more than 300 IND filing for cell and gene therapy product have been recorded, indicating that several developers and innovators are more attracted towards the cell and gene therapies. Therefore, increase in development of cell and gene therapy domain has led to the rise in demand of bioassay services for cell and gene therapy.

Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance. In fact, to obtain the regulatory approval for the biological products, such bioanalytical evaluations are must. Further, various researchers have demonstrated that the cell and gene therapies show different mechanism of actions; majority of the times these actions are unpredictable. As a result, different evaluation approaches are to be applied on the different therapies, due to which the evaluation of the aforementioned therapies becomes a challenging task for the innovators. Therefore, to overcome these issues, several contract service providers have emerged in this domain to develop bioassays.

Leave a Reply