- Halo Pharma is nearing operational activation of a new sterile injectable manufacturing line following a $45 million facility investment.
- The platform will support batch sizes from 250 to 250,000 units and has annual capacity of more than 50 million units based on 1 mL syringes and 250L batches.
Halo Pharma is entering the final operational stages of activating a new sterile injectable manufacturing line following a $45 million facility investment. The CDMO said the expansion is intended to address demand from US-based pharmaceutical companies seeking domestic sterile manufacturing partners.
The new platform is designed to support sterile injectable manufacturing from clinical development through commercial production. It features a high-speed Groninger UFVN FlexFill syringe, cartridge and vial filling line, along with an integrated SKAN isolator. Halo Pharma said the system is designed to support production efficiency and EU Annex 1 compliance.
Once operational, the line will support batch sizes ranging from 250 to 250,000 units and annual production of more than 50 million units, based on 1 mL syringes and 250L batches. The new capability expands Halo Pharma’s existing pharmaceutical development and manufacturing services covering oral solid dose, semi-solid and liquid formulations.
Halo Pharma recently hosted customers and industry colleagues to preview the new capabilities and is now progressing through the Good Manufacturing Practice (GMP) qualification process. The company expects the line to be brought online later this year.
“The domestic supply chain for injectables is at capacity, and this is the exact right time to bring this investment online. This state-of-the-art asset introduces the advanced capabilities and high standards that both emerging biotech and large pharma companies expect from a premium CDMO partner.”
Lee Karras, CEO of Halo Pharma
