Walters and Maestre featured in BioProcess International
Jun 23, 2021
Rapidly advancing cell and gene therapy pipelines are ushering in new needs and considerations within manufacturing infrastructure. CRB’s Peter Walters and Noel Maestre dig into this topic in BioProcess International’s “Four Design Factors Shaping Multimodal Cell and Gene Manufacturing.”
The cell and gene therapy industry is building rich research pipelines that are in need of dynamic facilities for commercial manufacturing. The caveat: they are being met with the traditional, single-product, large-scale manufacturing facilities of the past. “That incompatibility is widening as more cell and gene therapy products progress toward commercial production, forcing manufacturers to make a choice: either invest in major facility modifications and complex technology transfers to keep up or break from tradition and explore the potential of multimodal manufacturing,” said Walters and Maestre.
Siting the Horizons survey, an in-depth report of the industry, Walters and Maestre go on to share that flexibility, scalability, and speed to market are driving cell and gene therapy manufacturers away from traditional, dedicated facilities and opening the door to multimodal options.
Multimodal manufacturing is already being adopted in the cell and gene therapy industry. It’s currently allowing manufacturers to run several dedicated suites and produce multiple therapies at the same time, and all under one roof. The future of multimodal is equally exciting, “using individual good manufacturing practice (GMP) suites that can be engineered to campaign between products smoothly and efficiently.”
Walters and Maestre share that the key to multimodal success is understanding and controlling the risks. CRB engineers and specialists have identified four key areas of focus for multimodal use among cell and gene therapy manufacturers:
1. Facility flows
“A facility that is operating multimodal suites has greater risks of cross-contamination than one that does not. The facility’s segregation strategy must stand up to high scrutiny.” Considerations for facility flows include personnel and support materials as well as structural elements, like ventilation systems, air filtration, airlocking, and pressurization.
“Utility systems in a multimodal facility operating dedicated suites need robust risk profiles to ensure that water, gases, and clean compressed air are distributed as required without the risk of cross-contamination.” Utilities for multimodal facilities also need to be planned for possible, even frequent, product-agnostic manufacturing changeovers.
3. Cleaning and decontamination
“Cleaning personnel and their equipment and materials should move in and out of performance along segregated facility pathways. Operators also should have control systems in place for rapid identification, tracing, and isolation of contamination incidents.”
4. Equipment turnover and validation
“Operators will need to return equipment to a validated and consistent state of performance between changeovers. Operators also need well-documented procedures for dismantling, storing, reassembling, and calibrating that equipment.”
As cell and gene therapy continues to expand, a greater need for agile, multiproduct GMP manufacturing suites stands ahead. Learn more about multimodal manufacturing by reading the full article here.