Case Study: Secondary Packaging & Labeling
Accelerated Secondary Packaging & Labeling for Compassionate Use
Protocol to Patient in 7 Days.
The Challenge
A biopharmaceutical company engaged Tanner Pharma to execute secondary packaging and labeling under urgent timelines to support a Compassionate Use Program. A patient in South Korea required uninterrupted access to an investigational oncology therapy within a two-week window.
However, the product was only available at the final stage of the timeline, leaving minimal room for GMP packaging and labeling, batch documentation, and compliant release. Without rapid coordination and execution, there was a significant risk of treatment disruption.
This scenario required precise logistics, accelerated documentation workflows, and strict adherence to regulatory compliance to CU protocols.
Our Approach
Tanner Pharma rapidly initiated a tailored execution plan to support the program. A bespoke protocol, detailed production instructions, and a compliant batch record were developed and reviewed by all stakeholders within the same day.
Upon product arrival, Tanner completed GMP-compliant secondary packaging and labeling within 24 hours, followed by an expedited quality review and release process. Leveraging established capabilities in clinical logistics and supply chain management, Tanner coordinated immediate global shipment with all required clearance documentation, ensuring the therapy reached the patient in South Korea within seven days without disruption.
