The UK government is proposing to allow groundbreaking manufacturing methods that would permit cell therapies to be made at the patient’s point of care (POC).
On 21 October 2024, the draft legislation Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 was introduced in the UK parliament. The UK could be the first country to introduce a framework of this kind, with the regulations expected to come into effect across the country in the summer of 2025.
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POC manufacture means the production of therapies close to the place where they are administered, including in healthcare facilities such as pharmacies, operating rooms, ambulances, clinics and military field hospitals. It could involve modular manufacturing in prefabricated units that may be totally self-contained or require connection to the outside world.
POC manufacture would be an advantage over traditional, longer supply chains for drugs with a short shelf-life, drugs manufactured using the patient’s own cells, or when there is limited time to begin patient treatment. POC manufacturing is particularly useful for autologous cell and gene therapies, or 3D-printed medicines derived from a patient’s own blood, as it resolves the problems associated with long-distance, cold-chain transport of patient-specific raw materials and finished products. However, POC manufacture will have to prove that it can overcome potential risks to quality control and good manufacturing practice compliance.
Too many sites to inspect
Under the proposed system, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will focus its oversight on a control site. This will be a physical location named on the clinical trial or marketing authorisation application. The site would be responsible for overseeing all aspects of the POC manufacturing system, including the addition of new manufacturing sites and control of their activities.
Currently, all drug production occurs at manufacturing facilities, which must be listed on the marketing authorisation documents and subject to GMP inspections. Current arrangements would not be suitable for POC sites – a system in which there could be hundreds of production locations and the therapies have a short shelf-life. This requires small manufacturing sites close to treatment areas, which cannot all be inspected individually.
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By GlobalDataThe UK’s proposed regulations would provide the legal framework for POC manufacturing, including quality assurance. The MHRA said it is “developing detailed, supporting guidance and will engage with industry, academia and healthcare institutions to ensure that the necessary interpretation and procedural support is in place to support the implementation of the new regulations ahead of the date that the legislation will come into force.”
The draft legislation follows the MHRA’s public consultation in 2023, which revealed significant support for point-of-care manufacturing. There was also high support for the framework to include modular manufacture and home‑based manufacture.
Cautious US catching up
The US Food and Drugs Administration(FDA)/Center for Biologics Evaluation and Research (CBER) has not yet established guidance for POC or “distributed manufacturing” models. “We are in the process of trying to understand all of these different approaches and formulate policy accordingly,” said Heather Lombardi, director of CBER’s Office of Cellular Therapy and Human Tissue, at the National Academies of Sciences, Engineering, and Medicine (NASEM) workshop, “Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies,” held on 17 October 2023. She noted significant regulatory challenges, such as comparability between sites, staff training and maintaining an aseptic environment.
In the FDA’s view, POC manufacturing occurs at host sites near patient care. Distributed manufacturing is slightly different; it is a subset of decentralised manufacturing that occurs at multiple locations (decentralised facilities). Here, manufacturing is replicated and geographically dispersed to shorten supply chains and increase supply reliability. Oversight of operations is located at a central site under a single, unified quality system.
POC manufacture raises exciting possibilities for integration with 3D printing and AI. According to the Pharmaceutical Journal paper, “3D printing of pharmaceuticals and the role of pharmacy” (March 2022): “3D printing offers a unique platform which can manufacture medicines in response to changing situations and patient needs in a fast, digital and decentralised manner. The technology could be integrated into POC healthcare settings, and combined with AI to determine printability and ensure the quality and safety of the final printed drug product. Electronic prescriptions could be sent to a decentralised 3D printer location for real-time personalised medicine dispensing.”.
