6 Hot Topics for Disposable Solutions in Biomanufacturing
Add bookmarkJerold Martin, Sr. VP, Global Scientific Affairs, Biopharmaceuticals, Pall Life Sciences – BPSA and Chairman at the Disposable Solutions for Biomanufacturing conference, which took place in Brussels, 19-20 February 2013, shares 6 hot topics in the single-use and disposable solutions industry in 2013.
Biocontainer and Single-use system leak integrity: While some biocontainer suppliers have introduced 100% leak testing of biocontainers (bags), there are presently no 100% leak testing of assembled systems either by suppliers or available to users for pre-use or in-service confirmation of potential leak defects or damage. The desire for a 100% user pre-use/in-service leak test goes against principles of Quality by Design implemented by suppliers. Concerns about potential leaks are elevated by early implementation reports of high leakage rates. These rates have since been drastically reduced by supplier redesign of biocontainers and totes to eliminate potential leak sources and by operator training.
The application of "leak integrity" testing is complicated by the fact that SU biocontainers and systems cannot be pressure tested to the same pressures as rigid tanks and pipe systems, and contrary to common misperception, neither are actually correlated to microbial ingress. Even potential for liquid leakage is as much related to the size (especially fill height) of the container and surface tension of the fill liquid as it is to size and shape of hole or defect. Biocontainer and system suppliers individually and the BPSA are working with end users to find solutions and address exaggerated expectations.
Ciaran Kelleher, Principal Engineer with Global Technical Services at Janssen Biologics agrees that supply chain reliability is an area that they have been aware of and working on for the past couple of years. “In the case of single-use, we’ve actually been working on strategies for dual source for components, without the need to do a complete turnover or complete changeover of equipment.” Ciaran explains. “It has proved successful and I would expect that's what we’re going to continue throughout the rest of the supply chain as time progresses,” he concludes.
Assurance of resin formulation consistency (extractable) and change notification: Migrant species from single-use components ultimately becoming leachables in final dosage formulations are primarily a function of the plastic resin formulations and processing. To ensure that no changes in resin or processing can impact process leachables and final dosage, it is imperative that users and suppliers establish appropriate quality agreements and change notification programs that also go back to the resin sub-suppliers. Negotiating quality agreements and change notification agreements can be cumbersome and time-consuming. BPSA is working on a consensus quality agreement template that will expedite negotiations and ensure key controls are put in place to minimize changes and communicate any that may impact the final drug product.
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