By Carla Reed, president, New Creed LLC
Life sciences companies engaged in the transition from clinical to commercial scale are challenged by the ability of current suppliers to meet the demand for materials and services as the volume of source ingredients is increased and production capacity and yield are stabilized. In the case of cell and gene therapies, and related personalized medicines, these source materials directly correlate to specific patient populations, with related constraints.
In addition, in most cases the clinical production — and the ongoing commercial production — takes place through outsourced partners and service providers. This includes a complicated network of many small entities, in many cases geographically dispersed. This increases the complexity, with related requirements to develop supply chain models that can scale. Each of the critical stages needs to be planned for — from acquisition of source material through each of the steps until final delivery of a specific compound at the point of patient.
- Source Materials – In the case of these therapies the source ingredient is a live cell — blood, tissue, or other element. The collection process for these materials needs to be scheduled ahead of time, taking into account each of the process steps from the arrival of the patient — or donor — at the clinical site where this material needs to be drawn, carefully labeled, packaged for transportation, and handed over to the appropriate transportation provider for delivery to the production location.
- Production of Drug Substance and Related Drug Product – The steps in the transformation of source materials into the therapeutic compound frequently take place across a network of contract manufacturing providers. This adds complexity when transporting these fragile compounds, most of which have specific environmental risk factors.
- Packaging, Labeling, and Final Distribution to Point of Patient – Each step in this process needs to be carefully planned for, ensuring compliance with global regulations for item-level serialization, authentication, and association to each unique patient.
While each of these requirements and constraints adds time and cost during the development of the supply chain strategy and implementation process, there are additional benefits that can be derived.