The global contract manufacturing organization embedded within Pfizer has expanded its fill-finish services at its Kalamazoo, Michigan-based site.
In addition to vial-filling of small molecules and biologics, the facility also provides vial-filling of sterile suspensions.
“When we launched Pfizer CentreOne in April 2016, we promised our biopharmaceutical partners that we would be growing our capabilities to meet their needs,” Pete Stevenson, Pfizer CentreOne Vice President and General Manager, told Outsourcing-Pharma.com. “This is one step in fulfilling that pledge.”
According to Stevenson, Kalamazoo was an easy choice for expansion of its fill-finish services, as the company has been contract manufacturing complex APIs at Kalamazoo for 40 years.
The site also has experience and expertise in sterile injectables and tech transfer. “They produce 130 million vials for more than 100 markets for Pfizer each year,” added Stevenson. “Since 2012, the team has transferred in a dozen injectables, including five product launches.”
Additionally, Stevenson explained the site features one site leader and leadership team overseeing both API and sterile injectables operations. “Because Kalamazoo manufactures complex APIs, we have process experts right onsite. So if one of our biopharmaceutical partners has an issue with their API – not uncommon – we can quickly tap one of our API specialists,” he said.
While the addition of the contract manufacturing services doesn’t require the addition of personnel, Stevenson said Pfizer CentreOne is “prepared to invest in personnel as needed” as it continues to bring new contract manufacturing products into the plant.
Solid oral dose
Pfizer CentreOne also recently announced the addition of highly potent solid oral dose manufacturing to its service portfolio at its facility in Newbridge, Ireland.
The facility is currently approved to supply pharmaceuticals in more than 100 markets, and its regulatory approvals include the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil) and Pharmaceuticals and Medical Devices Agency (PDMA) (Japan).
According to the company, the site manufactures high-potency non-cytotoxic solid oral dosage forms for human use.