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Cell and gene therapy flips life sciences manufacturing on its head

October 12, 2021 - 355 views

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Cell and gene therapy flips life sciences manufacturing on its head

As cell and gene therapy grows rapidly, life sciences manufacturers will soon encounter new challenges, including a fundamental shift from ‘made-to-stock’ to ‘made-to-order.'

The best way to describe the growth of cell and gene therapy is dramatic. Research and Markets projects the global cell and gene therapy (CGT) manufacturing services market to reach $13.8 billion by 2026 from $7.7 billion in 2021.

Even today, 900 companies are currently pursuing therapies, and there are more than 1,000 active clinical trials. These numbers tell us that, while CGT won’t be overtaking established biotechnologies like monoclonal antibodies, immunoglobulins or Messenger RNA vaccines anytime soon, it is quite likely to emerge as a meaningful industry subsector in the very near future.

Major shift ahead

Any life sciences manufacturer looking to capitalize on this market opportunity will need to make some significant changes. Cell and gene therapy manufacturing is, in many ways, incompatible with traditional bulk manufacturing methods, which were designed for a uniform product that is “made-to-stock.” All the manufacturing work is done upfront, based on an anticipated market demand. This kind of manufacturing requires large and centralized facilities, a fixed system landscape and identical batches. It’s a process that typically takes 12 to 18 months.

Cell and gene therapies, especially with autologous grafts, are circular supply chains that originate with sourcing raw materials from the patient, following standard processes outside the body, and resupplying the drug product as “personalized materials” for reintroduction into the patient’s body. This process is typically measured in days rather than the weeks or months required in traditional manufacturing.

From a manufacturing perspective, this process could be unique to each patient, while requiring smaller production runs and more nimble production facilities. In other words, cell and gene therapy manufacturing isn’t made-to-stock; it’s made-to-order. This distinction is a critical one, necessitating a fundamental shift in life sciences manufacturers’ approach if they are to effectively manage quality and optimize the patient experience.

Smaller-scale and closer to the patient

Cell and gene therapies demand a manufacturing approach that is more decentralized. They also introduce significant new logistical challenges, with key parts of the process occurring in hospitals or clinics, within cold chain transit, or in a manufacturing facility. Manufacturing equipment, in turn, needs to be ultra-mobile and sized to sit at the patient’s bedside.

This equipment must also provide users with the ability to deal with patient variability, such as choosing between different consumable sets or the timing and sequencing of events at the processing stage. Master production records and batch records need to maintain GMP standards while working with “n of 1” conditions, including changing the ratio and sequence of reagents to build the optimal concentration of active ingredients.

One life sciences manufacturer told us that, while it is looking to scale up manufacturing systems for its vaccines and other traditional therapies, it is simultaneously exploring how to scale down those very same systems to better produce cell and gene therapies. This includes the equipment, the automation, the process steps, the data collection and the quality gathering systems.

CGT manufacturing’s made-to-order nature places the patient front-and-center. It also very much relies on all steps in the process happening relatively local to the medical center. Here are the basic steps in the process:

  • Cell collection from patient or donor, usually at a medical treatment facility, hospital or clinic
  • Logistical transport to a manufacturing/processing facility
  • Testing and analysis of samples to determine the manufacturing process to follow and the dosing quantity
  • Cell modification to acceptable specifications
  • Expansion of modified cells in a bioreactor
  • Cell harvesting and quality assurance (QA)
  • Logistical return journey, where product is packaged and returned to the treatment facility
New requirements create new challenges

This near-patient model introduces significant new requirements for life sciences manufacturers, including:

  • Highly mutagenic, potentially fissile, cellular nucleus-derived materials require higher than normal aseptic handling procedures and transportation protocols, including cold-storage controls.
  • Chain of custody requirements are critical for meeting GMP compliance, including any related to tamper-proofing and identity safeguards. Samples could move through a number of third parties, collaborating on cloud-based, multi-tenanted systems.
  • Assays for material characterization need to be developed to test and maintain guard bands for materials to remain within production and medical-grade specifications. These assays have to be incorporated within quality control systems to permit testing and release within acceptable timeframes for use of material with maximum potency.
  • Decision-making processes around QA and quality control (QC) are subject to change, with less command-and-control of QA and more local decision making based on additional QC. For cell and gene therapies, this often means in real-time and at the equipment itself.

    We’re seeing clients push real-time quality decisions lower in the manufacturing chain, leveraging smart equipment that reacts to a combination of raw materials, associated quality data from laboratory information management systems (LIMS), real-time analytics, digital twins and procedural records. We’re also seeing validated “test, adjust and release” algorithms emerge to ensure less reliance on human-based decision making as more data becomes available to build and release these intelligent solutions.
Creating a new model for CGT

The book on CGT manufacturing is not fully written, but the above requirements point to a changing landscape — one that is altering the way in which investigators, developers, sponsors and regulators view life sciences manufacturing and the systems required to support it. The resulting model will require new operational capabilities, supply chain integrity and distribution channels, as well as new technical partners to complete the offering.

Fortunately for pharma and its booming biopharmaceutical sector, there has never been a better opportunity to bring digital’s full benefits to bear on the complexities and challenges associated with CGT. One of the reasons more organizations, some with our help, are winning at the digital game is that the methods, goals and management objectives to attain a robust infrastructure are much better understood — and based on tough experience.

The time is right because affordable, open information and data informatics technologies are more available than ever, which will support and accelerate adoption. By connecting these systems to the organization and its business operations, life sciences manufacturers can realize the full range of benefits in their digital investments.

 

Digital Business & Technology life sciences manufacturing, cell and gene therapy

Bryan McSwiney

Bryan McSwiney is Global Director of Technical Operations for Zenith Technologies, a Cognizant Company. Bryan has over 25...

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