Serialization and Traceability Registration for a Biopharmaceutical Organization
Clarkston has deep and long-standing experience working with pre-commercial life sciences companies, and the challenges of transitioning – and in some cases, transforming – these organizations are well known to us as a firm. But, to paraphrase some common wisdom: there is always something new under the sun when supporting the launch of a Covid-19 vaccine in the middle of a global health emergency. Clarkston recently partnered with a biopharmaceutical company on a serialization and traceability registration.
“Building a plane in flight…;” or “Putting track down while on a speeding train …” – these timeworn phrases are apt for describing the pressure of implementing critical capabilities like serialization and traceability for a new supply chain network that changes by the day. Serialization software, like TraceLink, brings with it the flexibility to add new Contract Packaging Organizations to the system and execute proof-of-concept testing in a matter of hours. But there’s no simple technology fix for finalizing the SKU strategy that underlies the GS1 master data that software needs.
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More than in most product launch projects, the importance of real-time collaboration between Supply Chain, Production Planning, Commercial Operations, and IT became the critical success factor. And even when that was working brilliantly, it was always possible that a regulatory-driven change in market launch strategy could send us all back to the drawing board to model yet another new distribution network with full electronic interoperability.
Despite the challenges, the Clarkston Traceability Team delivered on their 2021 commitments and enabled multiple global channels for packaging vaccines compliant with US and EU regulatory mandates. 2022 will see the Team expand TraceLink functionality beyond the core pack and label functions to support full integration with the European supply chain network. This will ensure that the pack data needed for vaccine authentication at the point of “the jab” transfers to the National Medicine Verification Systems flawlessly, 100% of the time. Working closely with EU 3PL organizations, the client will also engineer process flexibility to support distribution of vaccine to non-EU nations under the Falsified Medicines Directive’s Article 22 and 23 stipulations. This will help provide significant amounts of vaccine to underserved regions of the world through the “COVAX” program overseen by the World Health Organization. It’s hard to imagine that the next serialized product launch for the client will require the level of flexibility, innovation and perseverance required to bring a Covid-19 vaccine to multiple markets during a pandemic; but the Team will always know that when it was tasked to do so, it *did* build a plane in midair, a plane will deliver life-saving product to the world.
Download the full Serialization and Traceability Registration for a Biopharmaceutical Organization case study here, learn more about our Serialization Consulting Services or contact us below.
Contributions by Noah Baker and Cally Eberle
