Cell and gene therapies: The challenges and opportunities for the supply chain

Cell and gene therapies have the potential to revolutionise the way we treat many diseases, providing new hope for patients with previously incurable conditions. However, their complex and personalized nature presents significant challenges for the supply chain.

Here, we look at the challenges for the cell and gene therapy supply chain – and the opportunities that are also arising.

Manufacturing complexity

The manufacturing process for cell and gene therapies is complex and involves multiple steps, from collecting cells and genetically modifying them, to testing and producing the final product.

This requires specialised equipment, highly trained personnel and strict quality control measures. Furthermore, the manufacturing process needs to be tailored to the specific needs of each patient which can further increase complexity.

Short shelf-life

Many cell and gene therapies have a limited shelf-life and require specialised storage and transportation conditions such as low-temperature environments or cryopreservation.

This adds complexity to the supply chain as any delay or deviation in storage and transportation can compromise the quality and efficacy of the product.

Regulatory requirements

Cell and gene therapies are subject to strict regulatory requirements, which can slow down the approval process and increase the cost of manufacturing.

To find out what 200 heads of supply chain are saying about the challenges facing pharma, read the latest LogiPharma benchmarking report for free.

The regulatory landscape for cell and gene therapies is still evolving and there are ongoing discussions around issues such as how to define quality control, how to manage potential adverse events and how to ensure long-term safety.

Cost

The high cost of manufacturing, coupled with the small patient populations, makes it difficult to achieve economies of scale. Moreover, the reimbursement landscape for these therapies is still unclear - and there are ongoing debates around how to price them fairly.

Technology advancements

Advances in automation, data analytics, and artificial intelligence can help to streamline the manufacturing process and reduce costs.

For example, Novartis has developed a closed and automated cell therapy manufacturing facility which is capable of producing a CAR-T cell therapy for certain types of leukaemia and lymphoma. The automated manufacturing process helps to improve consistency and reduce the risk of contamination, while also enabling cost savings.

Collaborations

Partnerships between companies in the supply chain can help to share expertise and resources, reduce duplication and improve efficiency.

Pfizer has partnered with Sangamo Therapeutics to develop gene therapies for certain rare diseases. 

The partnership combines Pfizer’s expertise in clinical development, manufacturing and commercialisation with Sangamo’s expert gene therapy platform technology. It enables both companies to leverage their strengths and accelerate the development of new therapies.

Patient-centric approach

Cell and gene therapies are highly personalised, and a patient-centric approach to the supply chain can help to improve outcomes and patient satisfaction.

Roche’s newly-developed digital health platform called NAVIFY Decision Support Portfolio for Precision Oncologyhelps helps physicians to make treatment decisions unique to each patient.

To find out what 200 heads of supply chain are saying about the challenges facing pharma, read the latest LogiPharma benchmarking report for free.

This is based on the individual patient’s molecular profile and combines real-world data, clinical guidelines, and expert opinions.

This patient-centric approach can help to optimise treatment plans and improve patient outcomes.