With the industry witnessing a boom in cell and gene therapy development and manufacture over the past few years, service providers are looking to address the various challenges in bioproduction – one of which is the lack of consistency in the early-stage development process.
Stacy Holdread, R&D manager of Cell Culture and Cell Therapy for Thermo Fisher, gave a presentation titled ‘Building Quality and Consistency into Bioproduction Media and Supplements’ during the CPhI Worldwide event that took place last week in Frankfurt, Germany.
After the presentation, BioPharma-Reporter spoke with Holdread about the challenge of variability and the company’s services for the upstream development process.
“Over the years we have learned that regardless of the raw material formulation, variability is being brought into the process, and the earlier we acknowledge that, the earlier we are able to control it,” Holdread said.
Lack of consistency, according to the executive, can be spotted in the upstream production processes for material used for biologic drugs including vaccines, monoclonal antibodies, and Chinese hamster ovary (CHO) cell line culture.
The executive cited four main potential sources of variability: “It can come through the environment, the cell line, the media and components, or the manufacturing process itself,” she explained.
Holdread added that the fastest way to fight variability is by working with the media and supplements, as the developers are usually not keen to change the cell line or the process, and the environment is often difficult to control.
However, the executive noted that the developers should “start monitoring and looking into what affects their process, as soon as they have their cell line complete,” and added that “the further along in the process they are, the harder it gets to make changes.”
Ensuring consistency is facilitated if the contract development and manufacturing organization (CDMO) follows the client’s development process from the beginning. However, according to Holdread, this is not always the case.
Asked about what can be done to get to a problem that already exists, the executive cited trust as the answer. “Our technical team works directly with the company to understand what the issue is and where it comes from, and then makes recommendations,” she told us.
“But it takes trust, so we work with the customer to build trust in order to make sure that we fully understand their problem and are able to help them, no matter what development stage they are at,” she concluded.