Digital technologies essential for innovation in cell / gene therapy manufacturing

According to Kevin Gordon, Chief Data Officer at OriBiotech, digitization is a priority for many cell and gene therapy companies, but few companies have fully adopted this approach. It’s a process, and very few are really paperless at this stage.

In addition to Ori, who has partnered with digital technology specialist Vinetti at May Gordon, Lyell and Tmunity cite it as a rare example of a cell and gene therapy company that has digitized and completely eliminated paper records from its manufacturing operations.

Gordon says Tmunity’s paperless capabilities have proved to be a significant improvement in control and transparency of the manufacturing process, spanning both vector and T cell production.

This view is shared by Jason Ramseth, Chief Product Officer of TrakCel, a cell and gene therapy software company.

Digitization is nothing new to biopharmacy manufacturing, but much of its focus has focused solely on human-oriented processes and controls, converting paper into electronic documents, Ramses explained. To do.

According to Gordon, part of the reason why few companies have digitized is related to how the cell and gene therapy sectors have evolved.

It also reflects the reliance of the cellular and gene therapy departments on processing systems developed for the production of protein therapeutics.

The equipment used to make these products is rarely designed to connect directly to the digital environment, Gordon continues. Many are not networkable and some have not yet adopted the latest advanced digital manufacturing standards.

Ramses also cites the origins of the traditional pharmaceutical sector as a problem.

He tells GEN that given the regulatory environment and influence that major pharmaceutical companies have given to the industry, they tend to be logical and easy to understand, returning to traditional low-risk legacy processes and systems.

solution

According to Gordon, the key to overcoming these challenges is ideally to have a solid plan to go paperless during the demonstration phase.

He says a solid proof of concept is needed to show that digital recording provides a more accurate source of truth. A great example we’ve seen is the Certificate of Analysis (CofA) report from LIMS. When the digital system runs out, both the QA and regulatory teams consistently produce reliable output.

The next step is to choose digital technology for process development, ideally a commercial-scale equivalent technology.

It is important for biopharmacy companies to consider the processes and equipment that may have worked in process development and how those tools work on a commercial scale. Gordon points out that they need to plan for success early and choose devices and equipment that will enable them to work in a digitally integrated world from the beginning.

By adding some important elements to the center of the manufacturing process, we begin to break the manufacturing black box. The transparency of what is happening in real time within the unit operation is stunning. Once the manufacturing team sees what’s happening in the process steps and knows that the information is immutable, they can trust it and start looking for more opportunities across the enterprise.

Connectivity

The last and perhaps most important factor needed to increase the use of digital manufacturing in the production of cell and gene therapy shows that this technology is reliable.

Gordon says it’s important for devices at the heart of the manufacturing process to browse and talk to the Internet.

Connecting to the outside world and reducing reliance on local data centers makes integration easier, updates easier, and end-to-end thinking of this process becomes a viable option, he explained. To do.

Fortunately, according to Gordon, even in highly regulated industries like the banking sector, all other major industries are adopting these tenants, so no new technology is needed.

What is needed is the maturation or replacement of the equipment needed to perform unit operations on digital native parts. As this progresses, regulators and QA / QC teams use more real-time information to gain greater control, greater visibility, and deeper control over what the final record of each process matches. You can be sure that you can achieve a level of comfort. What happened, Gordon continues.

For Ramses, collaboration is also important for the adoption of digital manufacturing.

There is no doubt that we are scratching the surface in terms of the impact of digitization and automation on the biopharmaceutical industry. Best practice sharing, standardization, and industry consortia / working groups are good ways to foster and accelerate this thinking. Tell GEN.

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