The Colanar FSV syringe filler will use the facility's existing single-use systems and will support both small molecule APIs and biologics projects at its FDA-inspected, cGMP-compliant manufacturing facility in Grand Rapids, MI.
The syringe filler – expected to be qualified and operational by the second quarter of 2018 – is also capable of handling cartridges, according to the parenteral contract manufacturing organization (CMO).
"GRAM purchased the syringe filler to support our client’s product growth," Steve Nole, director of operations at GRAM, told us.
The company has also seen a significant increase in request for pre-filled syringes over the last six to 12 months, he said.
When asked how GRAM plans to continue investing to meet this demand, Nole explained the company is building a new facility that will include a new filling suite with a high-speed integrated fill line, "utilizing best-in-class isolator technology."
The new facility is expected to open in 2020.
GRAM recently announced an investment from the private equity (PE) firm Arlington Capital Partners. According to the company, the new funding will enable it to expand and add capacity to meet a “the rising demand” for parenteral development and manufacturing services.