Many manufacturers need support in handling the logistics required by cell and gene therapies, which includes sourcing material from patients, maintaining proper temperature controls and distributing the products widely enough for patient impact.
Although the specifics of treatments can vary, all have one thing in common: each therapy is composed of living cells or viral vectors with a limited lifespan. It is critical that the therapies are transported on time and in pristine condition, to and from the manufacturer, and the treatment site for patient administration.
The dependencies between each touchpoint in cell and gene therapies are greater than traditional speciality pharmaceutical production, and the coordination needed to manage them effectively demands true connectivity.
People are part of the cell and gene therapy supply chain. For autologous therapies, the patient is at the start and end of a circular route. Along this non-traditional therapeutic journey, harvested patient cells and tissues exit and re-enter traditional supply chain boundaries in a biologically altered state. Meanwhile, a few healthy donors can provide material for hundreds of allogeneic therapy doses. For gene therapy, new genetic material is introduced into the patient's DNA. In all cases, this means that the supply chain needs to be cGMP-compliant with chain of custody tracking and overall orchestration.
Detailed knowledge of the complete supply cycle is necessary to develop therapy-specific risk assessments, and these should be used to design the logistics strategy for products. Patient-specific therapies require therapy-specific supply chains.
It is a significant step to go from clinical trials to a commercialised product, but there will be no distinct handoff from the clinical to the commercial supply chain. Manufacturing and logistics must scale up and out to serve more patients, while additional stakeholders join the supply chain. The commercial supply chain is the clinical supply chain with added complexity, which is caused by the barriers that patients will face in relation to access and affordability, as well as the high degree of interdependencies between the specific steps required.
Aligning the growing number of stakeholders is a challenge, and is one that must be proactively engaged. Cell and gene therapy owners should consider:
- making clinical decisions early on that have the capacity to scale up and out as the product moves to market
- focusing on logistics - from time and temperature-shipping requirements to the financial processes that are required to support commercial launches
- selecting a partner who can support the growing complexity - from increased production volumes to geographical reach and the creation of patient programmes
- creating integrated processes that prioritise the patients in the supply chain
- integrating data to support multiple outcomes, such as needle-to-needle tracking, chain of custody evidence and proof points for regulatory approval, to informpatient care and experience improvement, and enable effective communication between all stakeholders.
Innovators must overcome unprecedented challenges when therapies advance from clinical trials towards commercial launches, which requires redefining established approaches within many areas of commercialisation.
'Commercializing Cell and Gene Therapies' can be found on the company's website and looks into these issues.