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Large biopharmaceutical multinational
Monoclonal antibody
Qualification
Problem
Needed to de-risk commercialization schedule by bringing completing E&L qualification in unprecedented short timelines with limited resources. There was a lack of in-house E&L knowledge that meant this hefty workstream was not started early enough. This issue was escalated very high up and was in the spotlight at above-site leadership teams. A fast and effective E&L qualification approach was needed to keep the project on track.
Solution
The company used Fastnet to rapidly implement a science-based approach in a traceable GMP format, which enabling quality to perform facilitated reviews. The risk of leachables was significantly reduced by applying principles outlined in Margarian et al (2016). Only materials of constructions and surface areas of SUT located downstream of UFDF presented a risk to patient.
Result
The project was delivered in record time with limited resources. All involved received superb recognition for preserving the commercialization milestones of the product. The approach used would go on to be adopted at the global level across all sites.
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