Halozyme Gives Baxter Breach Notice After Hylenex Recall

May 18, 2010
Baxter’s Hylenex partner Halozyme has given the company a breach notice after a recall due to particulate matter in some vials of the hydration adjuvant. Halozyme suspects the small, flake-like glass particles are derived from the container closure system or other contact materials in the fill-finish process, Halozyme CEO Jonathan Lim said Monday. Baxter conducts final fill-finish activities for Hylenex recombinant (hyaluronidase human injection). If Baxter cannot remedy the breach, Halozyme can end the Hylenex partnership, Lim said.
Drug Industry Daily