The potential of decentralization

February 28, 2024 by Tom Lynch

Three questions with Tom Lynch, Ph.D.: Decentralized manufacturing for cell and gene therapy

When the COVID pandemic was in full swing, and there seemed to be a shortage of manufacturing facilities for vaccines, the potential of decentralized manufacturing became a hot topic for discussion. In short, a decentralized approach to cell and gene therapies enables distributed manufacturing and delivery, involving local treatment centers, on-demand manufacturing, and point-of-care administration.

We asked Tom Lynch, Ph.D., Director of Technical Sales and Scientific Support, what would be the positive and negative factors when considering building and using this model for delivering life-changing and life-saving therapeutics.

What factors/benefits are driving C&GT towards decentralized manufacturing?
The benefits of decentralized manufacturing in the context of cell and gene therapies are seen as a promising solution to address several key areas. For instance, for an autologous cell and gene therapy, the time required to manufacture a personalized drug can extend beyond one month.

Centralized manufacturing can have logistical issues, time delays, and production failures, making it less suitable for certain cell therapies, especially autologous ones. With a decentralized manufacturing approach, treatments could be administered on a more aggressive timeline.

As part of the CDMO industry, client experience is our key focus. And like with decentralized manufacturing, the patient experience and convenience can be significantly improved by tailoring physician treatments based on patient profiles. That could grow to individual patients having access to local centers that could personalize treatments and administer cell and gene therapies much faster.

• Innovation in Healthcare
  Innovation, including the development and adoption of novel therapies like decentralizedcell and gene therapy, is crucial for improving patient outcomes and addressing unmet medical needs.

• Reduced Logistics Challenges
  Decentralization reduces logistical challenges, from shipping and allocation to distribution.

Decentralized manufacturing is seen as a promising solution to address accessibility to personalized cell and gene therapies. By potentially reducing manufacturing times, advanced therapies could be more widely available to patients with various medical conditions, including rare diseases, while maintaining the crucial aspect of personalization.

What are the biggest challenges?
Decentralized manufacturing can be economically inefficient, leading to high therapy costs that may not be sustainable for patients and payers. Demonstrating a sustainable business model helps build confidence among stakeholders, including investors, healthcare providers, regulators, and patients. It shows that the innovation is not just a promising idea but can also operate effectively and efficiently over time.

Uniformity and safety are significant uphill challenges. All production systems in this context are designed to maintain a sterile, closed manufacturing environment. Automation is a key component to ensure consistent operation and product quality, ensuring that the process runs the same way each time.

Additionally, incoming raw materials need to be well controlled. While innovation is essential, it's not enough on its own. To gain widespread acceptance and adoption, a sustainable business model needs to be demonstrated. This means that the new approach to healthcare, in this case, decentralized cell and gene therapy, must prove its viability in the long term. Autologous treatments involve complex logistics, affecting treatment quality and timelines.

Cost-benefit ratios and prior approval authorization add complexity to treatment decisions. Production capacity limits patient access due to resource and time constraints. However, this level of personalization can be cost-intensive, making these therapies less accessible to many patients and payers. Decentralized manufacturing is seen to address this issue, as it may lead to broader patient access and economies of scale.

What programs or therapies are best prepared for a decentralized model?
Centralized manufacturing may be suitable for allogeneic cell products or when targeting larger patient populations, especially as the field of cell and gene therapies expands beyond rare diseases to more common indications. However, when therapies are manufactured for a single patient, such as CAR T-cell therapy, alternative manufacturing models like decentralization become essential to manage costs and resource limitations.

Decentralized manufacturing is particularly appealing for high-value, low-volume medicines that require personalization. This approach allows for efficient customization while potentially reducing the overall cost burden. Autologous therapies, which use a patient's own cells, are emphasized as a key aspect of the cell therapy landscape.

These therapies are considered the current state of the art and are likely to remain a preferred option for many patients. However, scalability and affordability remain challenges, which I will address in a future post.

• Learn about Aldevron’s Custom Manufacturing Services
• Have questions on this topic? Contact Tom Lynch
• Have an idea for a topic? Let us know!

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