May 30, 2019

When the patient is the product — some key challenges in cell and gene therapies

In personalized therapies — cell therapies, gene therapies, and neoantigen therapies — a patient is not just the recipient of a drug product. The patient is the product.

Whether cells or other “living” starting materials in personalized therapies come from the same patient being treated, or come from a donor, there is no separating the patient, the process, and the product. This patient-centric, next-gen paradigm introduces a whole new set of challenges to drug product processes and patient care. 

Patient and gene therapy steps

With the ISCT 2019 and ASCO 2019 conference underway this week, we’re having lots of great discussions on these patient-centric cell therapy processes and how to scale them. Manual workflows that support five patients in an early-phase clinical trial won’t work when you need to support 25 patients. Amid all the innovation being shared in Melbourne and Chicago, we want to take a moment to share some of the key challenges that need to be addressed to bring cell and gene therapies to as many patients as possible. 

As personalized therapies move through the development process, they require new strategies for clinical success and commercialization. The alternative — handling personalized therapeutic processes manually and with disconnected IT solutions — creates significant hurdles that can compromise clinical success and patient safety. Here are six of the most common challenges:   

6 challenges


Ordering and Scheduling

In many cell therapies, healthcare providers are not only prescribing and administering these therapeutics, they are also often kicking off the start of a personalized, regulated manufacturing process — and doing so far away from the controls of a manufacturing facility. Confusing IT systems, or inefficient paper-based systems, can create unnecessary complexity for providers and slow down the pace of treatment.


Healthcare providers are also often involved in the collection of fragile, living cells and other starting materials. Here again, regulated GMP manufacturing processes apply, even though cell collection usually doesn’t happen inside a traditional manufacturing facility. Chain of Identity and Chain of Custody — two sets of traceability records that are essential for patient safety and regulatory compliance — must be initiated and documented in these GMP processes, no matter where they take place.


Manufacturing Capacity
Living cells must be handled carefully, and processed as quickly as possible. No one wants to collect a patient’s cells only to have them arrive at a manufacturing facility that doesn’t have the capacity to process them. Personalized therapies require sophisticated, digital orchestration of manufacturing availability within the context of the full patient-based supply chain.


Logistics Orchestration
When the patient’s living cells are moved amongst multiple locations, focus on every production step matters more than ever and time is of the essence. A missed package or delayed flight may make the difference between an effective treatment and a lost opportunity. Effective supply chain management depends on visibility and control of integrated logistics.


Manufacturing Traceability
​In cell therapy, manufacturing can be distributed. Cells may undergo multi-step, multi-staff processing at an in-house manufacturing facility, a satellite facility, or a Contract Manufacturing Organization. Some cell and gene product processes may call for more than one facility to handle a therapy. And sometimes cell may be re-routed in mid-process to adjust for transit delays or manufacturing issues. Manufacturers need transparency, control, and consistency.


In-process labeling

In cell therapy, in-process labels often take shape at key steps in the product journey, with new patient-centric data flowing into the process along the way making label generation and reconciliation complex. Manufacturing and healthcare providers need real-time flexibility and transparency, so that everyone involved — regulators, sponsors, providers, and patients — can see that the right therapy is always traceable to the right patient.

While everyone understands that the science behind breakthroughs such as CAR-T cell therapy is complex, it is increasingly apparent that the underlying workflows require next-gen strategies that are just as advanced. It’s exciting to see all the new science at ISCT 2019 — and also encouraging to join the growing conversation about digital solutions that solve big workflow challenges in cell therapy!

Vineti’s platform is used every day to bring transformative cell therapies to patients. If you’d like to see our solution in action for yourself, please contact us to schedule a demo.