Catalent, a service provider for the biopharma industry, has completed the installation and commissioning of four high-throughput ‘high-bay’ CGMP manufacturing suites at its facility in Kansas City, Missouri, increasing its capacity and capabilities in oral solid dose forms.
The project includes the installation of a Gerteis roller compactor alongside stationary bin blenders, a capsule weight sorter, and a Syntegon high-throughput encapsulator, capable of producing up to 156,000 capsules per hour, in either powder or minitablet dose forms.
An automated capsule vision inspection system has been installed, with the capability to validate 100% of capsules and tablets manufactured. The design of the suites incorporates separate material and personnel entry and exit points, along with enclosed systems for material transfer to and from the processing equipment.
“The Kansas City site is an integral part of Catalent’s global manufacturing network for oral solid dose forms, and this latest expansion reflects the growth in demand for specialist products, including orphan and other expedited drug statuses, together with the corresponding need for sufficient flexibility, to manage a wide variety of customer batch sizes,” said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “The facility works closely with our early-phase drug development centers in San Diego and Nottingham, UK, and these expanded capabilities will allow faster, seamless transfer of projects between the sites to ensure rapid scale up and delivery of projects throughout the development phases.”
Catalent’s Kansas City facility provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The site also offers comprehensive clinical packaging services, including clinical supply management, package engineering, clinical manufacturing, primary and secondary packaging, global distribution and logistics, and return/destruction services.