The Situation We Faced: Risk Assessment of Failure Modes and Partners Understanding of Risk in Fill-Finish

This series, “The Situation We Faced,” is a CEO-type investigation interview into decision making, set within the context of other options, relative risk-reward situation, outcome and corporate culture ramifications, and market competitiveness positioning. So, sort of a war story reminiscence, but with clear technology or product context, some speculation about how other choices might have assisted or held things back.

As Hanns-Christian Mahler, CEO of Ten23 Health, explains the situation, “We saw up to 80% of the batch that had to be sorted out because of particulate defects in the final product, which eventually were clearly traceable to the primary packaging that was in use….

“I think in hindsight and also for future batches, the choice is to collaboratively work with the primary packaging supplier to make sure the incoming materials are free of contamination, but also to make sure the specifications are tight enough to ensure that the final product will be safe. Then to also work collaboratively with our customer, who is overseeing the supplier in this case, to ensure these things are now aligned.

“…and in hindsight also going back to appropriate development and formulation alongside primary packaging development integration. To make sure that before you go into GMP filling, you’ve been assessing all the failure modes along the way.”

Ten23 health facility in Basel, Switzerland, manufactures representative stability samples for regulatory filings (IND, IMPD, BLA, MAA) supporting setting product shelf-life, as well as serving engineering runs for later GMP fills. The pilot line fills analytical reference standards and provides fully representative pre-clinical supplies for GLP toxicology studies.

The GMP-approved, Swissmedic- and FDA-inspected sterile manufacturing site in Visp is equipped with an isolator line and flexible fill line for a variety of containers, produces clinical and commercial batches of vials, syringes, cartridges, and special devices with precision and minimal losses, handling batch sizes from 500 to 20,000 units.