Q&A: Sterile Injectable Manufacturers Gain New CDMO Option as Halo Expands

Halo Pharma is preparing to bring a new sterile fill-finish manufacturing platform online, built to support sterile injectable production from early clinical development through commercial supply. The platform pairs Groninger sterile filling technology with an integrated SKAN isolator system and is designed to run across a range of ready-to-use container formats, including prefilled syringes from 0.5 mL to 10 mL, vials from 2 mL to 30 mL, and cartridges from 1 mL to 5 mL, sourced from suppliers such as Schott, Stevenato, and Gerresheimer. The facility's contamination control strategy and equipment layout reflect current expectations for aseptic manufacturing, and the platform is intended to give sponsors flexibility as products move from clinical scale runs to full commercial output.

PharmTech spoke with Glenn Herring—who has spent 40 years at Halo Pharma and continues to support the project's development after recently retiring—about the design decisions, engineering considerations, and status of the build.

Watch the full video interview with Herring: Inside Halo’s New Fill-Finish Platform

PharmTech: What was the Biggest Challenge in Developing this Platform?

Glenn Herring: One of the biggest challenges was renovating an existing area for installation of the equipment and utilities, as opposed to having an open space where we could design and construct an optimal flow. As we worked through our contamination control strategy, we had to account for the surfaces, air locks, corridors, and production and filling rooms as they already existed. Those elements would likely be laid out a bit differently if we'd used a greenfield space instead of a renovated one.

What Format Range can the Equipment Handle, and How Does that Affect Changeover?

The machine has a defined format range. It was designed and built to run 0.5 mL to 10 mL syringes and 2 mL to 30 mL vials. Those are the fill constraints tied to the equipment's design and construction. In terms of changeover, the realistic window is really a sequence of manufacturing operation, then disassembly of the machine for cleaning and decontamination, followed by setup. There isn't a large difference in changeover time based on format size, it mostly comes down to the size of the machine and the number of parts that need to come off, be decontaminated, and then be reinstalled.

What Guided the Facility's Design from a GMP Compliance Standpoint?

Our primary design considerations were US GMPs and Annex 1. That shaped how we selected a manufacturer for the clean rooms and evaluated the surface materials used throughout, walls, floors, and ceilings, to satisfy Annex 1 requirements. This facility also has a dedicated air handler that doesn't draw air from any other area of the site. It's essentially an island, or a factory within a factory. That, combined with air locking and other engineering controls, helps us streamline our contamination control program and the monitoring that goes along with it.

How Does the Technology Transfer Process Work for New Products on this Line?

It depends on the stage of the transfer. If it's a commercial product that's already well understood, there's usually a lot of existing data we can build on. If it's a new product, we start with engineering batches alongside analytical method development, then move into transfer as required. From there, we get into filling and stability work, and if the product looks promising, we move into media fills and line qualification to support production.

Where Does the Project Stand?

We're finishing up construction of the facility. Primary installation is complete, and we're now in the startup phase. Next comes commissioning and site acceptance testing. Once site acceptance testing is done, we'll move into formal qualification work with our two key suppliers, SKAN, which supplies the air handler, and Groninger, which supplies the filler. We're positioning ourselves to be ready to conduct media fills for two container closure systems toward the end of 2026.