Halo Pharma is in the final operational stages of activating a new sterile injectable manufacturing line at its Whippany, New Jersey, facility, following a $45 million investment intended to add domestic capacity for pharmaceutical companies.
The contract development and manufacturing organization has hosted customers and industry colleagues for an open house preview of the platform and is proceeding through the good manufacturing practice qualification process. The facility is expected to begin operations later this year.
The new platform is designed to support sterile injectable manufacturing from clinical development through commercial production. It includes a high-speed Groninger UFVN FlexFill filling line for syringes, cartridges and vials, as well as an integrated SKAN isolator intended to improve production efficiency and support compliance with European Union Annex 1 requirements.
Once operational, the line will be able to manufacture batch sizes ranging from 250 to 250,000 units. Halo Pharma said it will have annual capacity to produce more than 50 million units, based on 1 milliliter syringes and 250-liter batches.
The investment expands Halo Pharma’s manufacturing offering beyond oral solid-dose, semi-solid and liquid formulation development services, which the company has provided for more than 20 years. The company will add sterile vial, prefilled-syringe and cartridge formats to its portfolio.
Halo Pharma said the project responds to demand from U.S.-based pharmaceutical companies seeking domestic sterile manufacturing partners. Chief Executive Lee Karras said domestic injectable supply chains are at capacity and described the timing of the investment as important.
“The domestic supply chain for injectables is at capacity, and this is the exact right time to bring this investment online,” Karras said. He said the facility will provide advanced capabilities and standards intended to meet the needs of emerging biotechnology companies and larger pharmaceutical companies.
Halo Pharma operates sites in Whippany and Montreal, Quebec, serving international clients. The company offers services including technology transfer, process and product development, production, scale-up and validation, and analytical method development.
The company said its integrated services allow it to work with clients across the development-to-commercialization process or at individual stages. It did not disclose customer commitments, products planned for the new line, initial production schedules or revenue expectations related to the expansion.