Catalent has announced a $12 million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, Missouri.
The project will see the addition of two new analytical development laboratories to support the growing demands of assay development for both traditional biologic and advanced biologic modality programs.
The first of the two new laboratories will cover approximately 3,500 sqft and will be completed by the end of October 2022, with the second, measuring 3,000 sqft, due to be operational in the first quarter of 2023. The expansion will create approximately 50 new scientific jobs at the site by February 2023.
The additional capacity will increase the capabilities that Catalent has across its network in both standalone services and integrated development programs. In recent months, Catalent has expanded its CMC large molecule analytical services at Kansas City to include additional services in excipient and media components support, extractable and leachables testing, droplet digital PCR technologies (ddPCR), and next-generation sequencing (NGS), to support customers’ growing needs to accelerate programs and meet regulatory requirements.
“The need for timely analytical support in development, characterisation and CGMP testing is critical for innovators across the biologics pipeline, with delays affecting the overall time to get new drugs into the clinic, and ultimately to patients,” said Jeremie Trochu, Division Head for BioAnalytics at Catalent. “Our team at Kansas City serves as a strategic partner for customers of all sizes, and this expansion will allow it to support the increased demand and assay requirements for broad-based and orthogonal analytical CMC services for both traditional biotherapeutics and advanced modalities such as antibody-drug conjugates, cell and gene therapies and mRNA vaccines.”
Catalent’s Kansas City facility is a centre of excellence for its standalone biologics analytical services business, with over 30 years of experience providing cell-based assays and characterisation studies for drug substance, drug products and intermediates, for both innovator and biosimilar products.
It also provides a range of integrated services for oral solid dosage forms as well as comprehensive clinical packaging and supply services. In April 2022, Catalent announced the completion of an expansion project to increase capacity and capabilities for producing encapsulated oral solid dose forms at the site.
