The Patient-Centric Manufacturing Model

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Patient-centric drug development and manufacturing incorporates the perspectives of patients in the design and production of medicines and is recognized as important by health authorities and industry organizations, which have developed a variety of guidance documents, tools, and methods for its implementation (1,2). Studies show that patient-centric medicines improve patient adherence (1).

FDA states that incorporating the patient voice into drug development includes the use of systemic approaches for collecting and using patient input in drug development, identification of best practices for facilitating patient participation in clinical trials, capturing information on patient preferences, and identifying information beneficial to patients during treatment (2).

BioPharm International® spoke with Jason Bock, co-founder and CEO of CTMC, about the impact of patient-centered medicines on the industry and considerations for the manufacture of these products.

Industry impact

BioPharm: How has patient-centered medicine impacted bio/pharmaceutical manufacturing?

Bock (CTMC): The future of medicine lies in personalized cell therapies, where a patient’s own cells are used to create powerful treatments. New, fit-for-purpose manufacturing models are needed to deliver on this promise. The shift to personalized medicines is demanding more flexible and streamlined manufacturing models to enable on-demand capacity for individualized, single-dose batches.

Currently, demand for cell-based therapeutics outpaces manufacturing availability. Extended wait times for treatment are not an option for patients with advanced cancers. To facilitate the production of autologous cell therapies, the supply chain needs to adapt to align with demand and patients’ needs. Having patient-adjacent, industrial-grade manufacturing capacity is crucial for reducing turnaround time, while maintaining product quality. This manufacturing model simplifies logistics and creates a cell therapy supply chain that prioritizes faster delivery to the patient, which will be vital to realizing the full potential of patient-centered medicine.

BioPharm: How can patient-centric approaches improve manufacturing processes?

Bock (CTMC): Personalized therapies that are manufactured in close proximity to treatment centers offer the potential to significantly decrease inefficiencies and costs. This proximity allows for streamlined logistics, reduced transportation expenses, and minimized risks associated with extended wait times. The localized production of personalized therapies in industrial-grade facilities can lead to improved safety and quality control measures, as it enables tighter oversight and adherence to GMP [good manufacturing practice] standards. This streamlined approach has the capacity to enhance the accessibility, affordability, and reliability of personalized treatments for patients.

Production scale up

BioPharm: What are some manufacturing models for scaling up the production of personalized cell therapies?

Bock (CTMC): The use of a patient’s own cells in biomanufacturing adds a layer of complexity to every step, from process development to scale-up.

A regionalized manufacturing model that simplifies the logistics of production and delivery is a promising solution for scaling up these types of cell therapies. In this model, a manufacturing network of connected nodes would be utilized. Digital quality systems would connect each node and enable consistency of processes and data integration. On a bioprocessing level, automated, closed-system processes reduce the risk of error and contamination while accelerating manufacturing and reducing overall costs.

The production of cell therapies also often involves genetic engineering steps, adding further complexity to bioprocessing. As gene editing technologies, [such as] CRISPR [clustered regularly interspaced short palindromic repeats], continue to evolve, manufacturing processes will need to adapt to keep pace with these advancements.

Read the article in the Manufacturing and Facilities 2024 eBook.

About the author

Susan Haigney is lead editor for BioPharm International®.

Article details

BioPharm International®
eBook: Manufacturing and Facilities
November 2024
Pages: 11–12

Citation

When referring to this article, please cite it as Haigney, S. The Patient-Centric Manufacturing Model. BioPharm International Manufacturing and Facilities eBook. 2024 November.