Inside Halo’s New Fill-Finish Platform

Halo Pharma has opened a new sterile fill-finish manufacturing platform for a limited preview ahead of GMP qualification, giving PharmTech an early look at the production suite and the team building it out. The platform is designed to support sterile injectable manufacturing across the full development lifecycle, from clinical-scale batches through commercial production. It pairs Groninger filling technology with integrated SKAN isolators and ready-to-use container formats from Schott, Stevenato, and Gerresheimer, spanning prefilled syringes (0.5–10 mL), vials (2–30 mL), and cartridges (1–5 mL). The design incorporates current contamination control strategies aligned with modern aseptic manufacturing expectations, positioning the facility to serve both clinical and commercial sterile injectable programs.

Glenn Herring, technical operations consultant to Halo Pharma, walked through the engineering and regulatory decisions shaping the new suite. "One of the biggest challenges was renovating an existing area for installation of the equipment and the utilities, as opposed to having an open space where we could design and construct an optimal flow," Herring says. That constraint shaped how the team approached contamination control across surfaces, air locks, corridors, and filling rooms.

The filling line itself is built to handle 0.5–10 mL syringes and 2–30 mL vials, with changeover times driven less by format size than by disassembly, decontamination, and reinstallation of machine components, according to Herring. Design decisions leaned heavily on US GMP and Annex 1 requirements, informing everything from cleanroom materials to a dedicated air-handling system. "It's kind of an island or a factory within a factory at the site," Herring says describing the isolator's independent air supply.

Construction is largely complete, with the team now in startup, moving toward commissioning, site acceptance testing, and formal qualification with the suppliers SKAN and Groninger. Herring adds that the facility is positioning for media fills across two container closure systems by late 2026.