By Nina Vas, Vice President, Clinical Distribution, Cell & Gene Supply Chain, Marken
Cell and gene therapies promise life-changing outcomes for patients facing debilitating and rare diseases. Immunotherapies and stem cell treatments have given new hope to cancer patients, while gene therapies have the potential to cure by targeting the root cause of disease.
Because cell and gene therapies use living cells or genetic material, they are difficult to research, develop and scale. To develop these therapies, clinicians need to collect cells from a patient, deliver those cells to the manufacturer within days (following strict temperature requirements) and return the therapy to the patient - again, under strict conditions.
Due to their fragile nature and complex development pathways, cell and gene therapies place extreme demands on clinical and commercial supply chains. In this article, Marken’s Nina Vas discusses the heightened attention to chain of custody, environmental conditions, packaging, regulatory, technology and customs requirement that successful supply chain strategies for cell and gene therapies demand.