Grand River Aseptic Manufacturing (GRAM), as the name suggests, is a leading sterile injectable drug manufacturer based in Grand Rapids, Michigan. Following significant investments in state-of-the-art facilities and equipment, GRAM has capacity for fill-finish biologics, small molecules, and vaccines.
Ahead of CDMO Live, we had the opportunity to sit down with David Powell, Vice President of Business Development at GRAM.
“We strive to have the latest manufacturing technology. All our equipment is always cutting-edge. But at the same time, as a good old Mid-west company, customer focus, authenticity, and transparency are the hallmarks of who we are.” say David.
Listen to the full interview here:
New facilities and fill-finish capacity
During the COVID-19 pandemic, GRAM helped manufacture the vaccine. “We pivoted and quickly invested in more capacity. Now, post-COVID, we have a significant amount of capacity available to our customers, with a total of three fill lines and a fourth on the way,” David explained.
With newer capabilities and facilities, GRAM has pivoted to specialize in biologics fill-finish.
“That is where our sweet spot is. We’re not into drug substance, we’re not in oral solids, we are really just focused on fill-finish and helping our customers, large or small, take their products through and get it to market.”
GRAM have announced plans for a third manufacturing facility focused on syringe and cartridge filling to complement existing capabilities.
“We’re leaving plenty of space to also get into more downstream auto injector and other device manufacturers assembly for our syringe and cartridge customers. We realize we need to continue to expand in there to match the market demand.”
The new facilities are all Annex 1-ready, says David. “We had the benefit of designing facilities knowing Annex 1 was coming, so we already knew the answers to the test before it was given, but there are many CDMOs that are having to retrofit or change facilities to meet these expectations.”
Sustainability has been built into the design of GRAM’s new facilities, reducing the carbon footprint and the amount of water for injection or utilities consumed by the equipment. GRAM works with commodity vendors that are innovative, especially in the glass space, to manufacture vials with a lower carbon footprint without compromising quality.
Do you want to build better relationships with contract manufacturing partners?
Don’t miss this interactive roundtable at CDMO Live, hosted by Kevin Wess from Grand River Aseptic Manufacturing. Register today for your free ticket.
Growth in self-administered drugs
A major trend for the industry is towards self-administration of biologics products, driven in part by the GLP-1 market growth.
“You’re seeing more devices and innovation in that space, which is great to see. So beyond just auto injectors to on-body devices and other really sophisticated drug delivery mechanisms, which are patient-centric.”
Think beyond the tech transfer
David shares advice for creating better partnerships with contract development and manufacturing organisations:
“Don’t just focus on the tech transfer. Think about the lifecycle of your relationship and make sure across the board, it’s a good fit for your company. It’s somewhat of a marriage and switching is very expensive.”
He emphasized the importance of a good fit not just with tech transfer teams but also with supply chain teams who will need to take the product to market.
In conclusion, “You should really select a CDMO based on the facility and the people you’ll be working with all the time. If you don’t feel the fit, it’s not going to get any better, so you should feel that out right away.”
