Delivering regenerative medicine from lab to clinic: challenges for the supply chain

Rich Quelch of Origin discusses how we can achieve effective supply chain management for regenerative medicine



Pharma IQ
09/05/2019

Regenerative medicine (RM), as a sector, has the promise of changing how we treat and prevent chronic illness forever. Harnessing the body’s own repair mechanisms, RM holds the promise of engineering tissues and organs to functionally heal “the irreparable”.

Advances in science and greater investment are pushing the boundaries of RM. However, the use of living cells as therapies presents real supply chain challenges which need to be overcome before regenerative medicine can truly deliver on its curative promises…

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The far-reaching benefits of regenerative medicine

Regenerative medicine is one of the most exciting modern advancements in science and as an industry it’s expected to be worth $81 billion by 2023.

As a more efficient and less invasive alternative to transplanting cells or organs to replace damaged or lost tissue, medicine-based approaches are now able to successfully stimulate the body’s natural ability to repair itself.

The regenerative medicine market is forecast to be worth $81 billion by 2023

For example, stem cells can generate vital growth factors to naturally reduce inflammation, increase muscle mass, repair joints, grow hair and boost the immune system. Organ regeneration and 3D printing are replacing the reliance on the failing donor system and overcoming the issue of organ rejection. The root causes of ageing are being better understood and delayed by using stem cells.

Beyond more effective medical treatments that can be applied routinely, RM also has the potential to cure many of today’s “incurable” diseases and prevent the preventable ones too.

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Commercializing new therapies

Today, RM is largely confined to a research environment. In fact, there were 1,028 clinical trials for regenerative therapies taking place globally at the end of 2018.

However, while billions are being spent on research and clinical studies, little resource is being allocated to the commercialisation of RM at scale. Today, many big pharma companies are partnering with Medtech startups to in-license products in early clinical development stages, but it could mean big pharma misses the boat.

In a recent document published by the UK Government, policymakers stressed the importance of commercialising new therapies and ensuring the NHS is fully prepared to deliver innovative treatment.

Brexit may complicate this process, but the UK is likely to have the opportunity to develop its own framework outside of the EU regulatory system to accelerate the development of new therapies and its economic potential.

 

Supply chain management

Once RM is ready for commercial application, the whole healthcare ecosystem will have to adapt. This is particularly true for supply chain management.

RM supply chain networks will need to be the most complex the industry has seen because products are either personalised or matched to the donor-recipient and are highly sensitive to exogenous factors like time and temperature.

Advanced IT systems will aid end-to-end traceability, giving clinicians real-time access to view the progress of therapies and their distribution. They’ll also allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible.

Once regenerative medicine is ready for commerical application, the supply chain will need to adapt quickly and effectively

Temperature-control logistics solutions will be vital for transporting materials from the site of harvest, to manufacturing facilities, and to medical institutions under strictly controlled conditions. Cryopreservation is one technique to keep RM at optimum temperature using vapour phase nitrogen, but many clinical settings are currently ill-equipped to handle such equipment.

Onsite production is an alternative when products are derived from a patient’s own cells, however, the hospital would need to comply with a host of regulations including installing a Good Manufacturing Practice (GMP)-licensed clean room.

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