Single-use technology has now been established as the major technology used within global bioproduction facilities. While several challenges still remain, they are becoming less of an issue as the industry moves forward. Graeme Proctor, Product Manager Single Use Technologies at Parker Bioscience Filtration, discusses some of these.
Single-use processing has historically had limitations with scale of operations when compared to stainless steel setups, however several trends are now mitigating the impact of these limitations. “Increased titers and the move towards an increased number of smaller, localized manufacturing sites is allowing the current scale of 2,000 L within single-use to be an acceptable solution for production operations,” says Proctor. “Scale out of 2,000 L vessels, rather than scale up is now becoming the preferred option. Other factors and trends to consider are a move to continuous processing, and growth in the area of personalized medicine and targeted treatments, resulting in smaller batch sizes when compared to the blockbusters of the past.”
“These trends allow single-use technology to meet the production requirements for processes that have previously been uneconomical or dominated by conventional stainless steel setups. Smaller batch sizes and the implementation of single-use technology also offer greater flexibility to adjust to customer needs and to mitigate risk in the supply chain.”
“Industry reports have suggested that historically, creating a fully customized single-use assembly with all the required documentation, from concept to customer delivery, can take in excess of 16 weeks due to challenges around validation and qualification which can create delays in implementation, if not managed correctly,” explains Proctor. “Alternatively, generating a configured single-use assembly from a pre-validated ‘design space’ has advantages in design, component compatibility and lead time.“
For instance, at Parker Bioscience Filtration, a single-use assembly created to a customer’s design utilizing components from a pre-validated design space can be delivered in just 8 to 10 weeks including full documentation from concept to delivery, about half the time required for a fully customized assembly.
Proctor explains: “After the initial concept request, drawings are provided within 3 working days to the customer for approval or revision. Once the drawing is approved, non-irradiated samples for form, fit and function can be ready to ship within one week. Once testing and any final design modifications have been completed the final drawings are approved by the end user and orders are placed, the finished product is manufactured and delivered within 8 weeks.” Parker has called this ‘Design Space’ SciLog® Select Go.
“Customers can pick items from the library almost like childrens building blocks to build a single-use assembly, knowing that it works in a logical, controlled and validated manner with all of the supporting documentation in place. Within this library, we have chosen many industry standard components to give our end users as much flexibility as possible, thereby enabling a predictable, reliable and robust journey from concept to implementation.”
Parker is the global leader in motion and control technologies – and has applied these technologies to its biopharma single-use and filtration portfolios. We have designed, developed and delivered automated systems such as the Parker SciLog® FD System, a fully enclosed, automated system which can both filter and dispense bulk drug substance into either bottles or bags prior to shipping to final fill sites. Parker Bioscience Filtration has been able to demonstrate the value of bringing automation to previously manual steps “Automation is important to reduce potential human errors,” says Proctor. “It saves operators a lot of non-value added work and mitigates risk in the process. This is an added value to the manufacturer and leads to predictable outcomes resulting in increased productivity, process robustness and safety.”
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