The Need for Automated and Standardized CGT Manufacturing (BIO 2024)

While cell and gene therapy (CGT) manufacturing must remain flexible out of necessity, it is also important to standardize processes at an industry level while establishing aseptic-friendly automated operations. Standardization, in particular, is important from a scaling perspective, says Joe Garrity, senior director and head of Autologous Cell Therapy, Lonza.

During BIO 2024, Garrity pointed out the many challenges incurred on the cell therapy side. “It stems from supply chain to operations to clinical sites. There's just so much that needs to go into, specifically, autologous cell therapies, with the batch quantities going into the hundreds and thousands that we're seeing from some of [the] large drug developers.” Thus, he says, standardizing the manufacturing process allows for robustness and process control across the board.

Garrity also notes, however, that even with standardization, “it's not a one size fits all”. Instead, he says, “[much of the time,] it's a little bit of a one size fits most, and you're going to have to be relatively variable, but in the end, the overall standardization of the manufacturing process and the intent of that remains the same because it's better control at scale. Once you find something that really funnels that process robustness and that scalability, you … stick with it so it's reproducible time and time again.”

In discussing whether it’s possible to have manufacturing processes that are both standardized and flexible, Jerry Jiang, clinical application specialist, Personalized Medicine, Cell and Gene Therapy, Lonza, says, “Definitely. One of the things that we really have to start standardizing is the release criteria and the quality of the cells that are being put into the patients. [The] material that comes in is going to be different, but standardizing what we expect the cells to do and behave and what they look like is going to be a huge part of what the standardization process needs to overcome right now.” However, flexibility remains in the details. “[T]he standardization is the same, but the flexibility of the process allows these different companies to optimize the process with their ‘secret sauce’ that will really differentiate their treatment from all the other treatments out there,” says Jiang.

“We definitely need to standardize the way we are inspecting and checking the cells before it goes into a patient, but the flexibility allows each company to … show off their technology and allow for them to shine with the advancements that they've made,” Jiang adds.

Click above to view the full interview. BIO 2024 occurred on June 3–6 in San Diego, Calif.