Case Study: Secondary Packaging & Labeling
One Model for Secondary Packaging, Labelling and Kitting Across 13 Markets
4 Languages. 800 Kits Per Quarter.
The Challenge
A biopharmaceutical sponsor needed uninterrupted post-trial access for patients across 13 countries and four languages as the program moved toward Phase II and beyond, with patient demand shifting and no fixed end date in sight. Converting a single bright-stock product into 13 compliant, language-correct kit configurations meant coordination risk multiplied with every market; any gap in supply meant a gap in patient care.
Our Approach
Tanner built a single integrated operating model covering secondary packaging, labeling, kitting, component procurement, translation support, and QP release, as one program with one point of accountability. A quarterly forecasting cycle converted patient schedules into recurring production runs, each carrying a lot number and expiration date, with QP release embedded into every cycle to confirm EU GMP compliance before distribution. With Tanner’s support, forecasting, production, labeling, quality review, and release ran as one coordinated cadence, delivering 800 kits per quarter, 16,000 vials over the program's life, and zero interruptions to patient treatment across all 13 markets.
