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POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products

By: Stefania Cislaghi – GMP Compliance Advisor & Auditor – PQE Group

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Introduction to current and future manufacturing processes features and timings

Standard products, including recombinant biotechnological ones and newly developed mRNA vaccines, rely on manufacturing processes performed at pharmaceutical companies’ sites with validated equipment, processes and analytical methods: batches are manufactured with a standard process, analyzed according to predefined specifications and then released by site’s QPs for clinical or commercial purposes. Regarding timeframes and thinking about a recombinant biotech product, as a worst case, the overall manufacturing process can last even for 2 months (or also longer); final drug product manufacturing, analysis and release prolong timelines of an additional one month, making the final product Lead Time quite consistent, with a realistic mean of 3 months from cell thawing up to final shipment to patients.
Point Of Care_banner insight
 

The next (and, indeed, already current!) generation of medicinal products is represented by Advanced Therapy Medicinal Products (ATMPs), blood components, 3D printed materials and combined products. In two words, the next frontier is personalized medicine.

Such products typically require to be manufactured as much close as possible to patients, namely at the Point Of Care (POC). Transferring the process (including control and release) closer to patients necessarily require that personnel, knowhow, facilities and equipment are also moved: this new model shifts single (or few) centralized manufacturing sites (represented by companies’ facilities) to multiple dislocated sites, typically inside the hospitals in which patients are treated.

Technical and Regulatory challenges of Point Of Care Manufacture

UK MHRA is currently a pioneer in such products’ regulatory guidelines and has already understood the importance of POC and its natural implications for both companies and patients. MHRA has started brainstorming on such topic in early 2020 and has launched a public consultation in August 2021: results of such consultation are currently under evaluation and an official guideline is expected soon.

A regulatory framework specifically designed for POC manufacture will be developed; some key features have already been released and are mostly based on GMP guidelines, Master File systems and the “hub and spoke model” used for blood transfusion and cell/tissue transplants. Key elements include:

  • The control site concept, responsible for overseeing POC manufacturing system including the addition of new manufacturing sites, control of each manufacturing location and acting as primary focus of regulatory controls for MHRA
  • A POC Master File as main source of information, to be considered a living document that includes also notices of significant events/issues and to be regularly reviewed by MHRA for compliance with GMP, GCP and GVP (including each area inspections information)
  • Specific considerations on new POC sites addition and comparability establishment
  • Particular attention to process development, validation and control including data required for finished products testing, stability and labelling considering that these could be significantly different respect to conventional pharmaceutical products and may need to be agreed on a case by case basis
  • Constant, open dialogue with regulatory authority to agree on case by case specifications, controls and Risk Management Plans to effectively manufacture and deliver the highest level of therapies to patients

Conclusions – Following a truly disruptive innovation landscape

Point Of Care Manufacturing is truly already representing a disruptive innovation in the pharmaceutical landscape. The topic will significantly explode in the very next future as personalized and innovative therapies will became the next standard of care for a significant number of diseases.

FDA and MHRA are already on the way… let’s hope Europe will follow soon!

 

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PQE Supports Marketing Authorization Holders, Manufacturers of API and Manufacturers of Finished products. Our experts have significant expertise in Regulatory Intelligence to make you aware of regulatory requirements applicable to Clients’portfolio and PQE could offer a CMC Regulatory support at every stage of development, registration and life cycle management.
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