Catalent Expands Biologics Analytical Capabilities With New Laboratories at Center of Excellence in Kansas City, MO

Catalent recently announced a $12-million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, MO. 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 square feet and will be completed by the end of October 2022, with the second, measuring 3,000 square feet, 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 stand-alone 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, characterization 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 center of excellence for its standalone biologics analytical services business, with over 30 years of experience providing cell-based assays and characterization 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.

For nearly three decades, Catalent Biologics has built capabilities and expertise in development, manufacturing, and analytical services, now spanning new biological entities, biosimilars, plasmid DNA, cell and gene therapies, vaccines, sterile injectables, mRNA, and antibody-drug conjugates. It has developed 600+ antibodies and 80+ recombinant proteins, with 120+ active clinical trials and 16 marketed biotherapeutics use GPEx cell line engineering technology. An additional 45+ commercially-approved products have employed Catalent Biologics’ manufacturing and packaging capabilities.

Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. With a comprehensive cell therapy portfolio and deep expertise in viral vector development, scale-up and manufacturing, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV) and other viral vectors, viral vaccines, iPSCs and autologous and allogeneic cell therapies.

Using advanced technologies and tailored solutions from clinical to commercial supply, Catalent brings better biologic and advanced treatments to patients, faster.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 19,000 includes more than 3,000 scientists and technicians.

Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.