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Dec 05th, 2023
Dec 05th, 2023
Single-use technology and disposable technology have been gaining momentum in the biopharmaceuticals industry over the past decade. Whilst this might be the case, a barrier to transition persists owing to a lack of standards and regulatory guidance.
Tony Hitchcock, technical director at Cobra Biologics, has therefore offered up three tips to simplify the process of moving to single-use for biopharmaceutical companies.
“First is actually doing full technical evaluations and knowing that the process does work in single-use systems, that they generate comparable material of the right quality.”
“The second is going through vendor selection and design processes, doing a full assessment of the vendors, doing mock-ups of systems as well, the whole process, running individual operations.
“But then also looking at what back-ups you’re going to get from your vendors and not just looking at the quality systems but also their capacity to deliver and maintain supplies to your required production schedules.”
“The other I think is looking at the full implications of the implementing single-use systems across a whole company in terms of impact on staff and training of staff systems, but also project flows throughout your company, the quality systems around that, and taking a holistic view of that rather than trying to just do it as a small, individual project.
“You need to understand the full implications of that project. If you do that, then it’s possible to successfully implement single use systems, either for whole processes or specific operations.”