SAFC expands ADC and bulk drug manufacturing in CA, MO
Sigma-Aldrich’s custom manufacturing division has expanded its facility in St Louis, Missouri, allowing it to commercially manufacture antibody drug conjugates (ADCs).
The site was built to meet SafeBridge category 4 compound handling standards for high potency compounds. It is awaiting validation and planned to open in Q3 this year. SAFC said the expansion will appeal to customers who want a single supplier from discovery to commercialization.
The St Louis investment is backed up by expanded storage and manufacturing capacity for highly-active substances at the company’s facility in Madison, Wisconsin.
Gilles Cottier, SAFC President, said the ADCs are a growing market which is expected to further expand over the next few years.
“This strategic expansion is the latest in a series of enhancements in our ADC offering designed to support this important therapeutic area and to help our customers to seamlessly scale ADC production from preclinical to commercial phases.
“Our offer can bring customers’ molecules to the clinic faster, with the ease of working with one supplier from start to finish. With the added support of our recently launched ADC Express service, we believe SAFC presents the most comprehensive offer in the contract manufacturing market.”
California site
In a second investment, SAFC expanded its facility in Carlsbad, California for finished biologics manufacturing, testing, and filling.
The facility will produce bulk drugs for clinical and commercial uses, as well as performing fill-finish services for gene therapy, viral vaccine and immunotherapy customers.
“Gene therapy is an emerging technology, and our SAFC and BioReliance sites in Carlsbad, Rockville, and Glasgow have supported this growing industry for years,” said Gilles Cottier. “This investment is pivotal to our customers and reflects SAFC’s continued dedication to providing the infrastructure customers need to bring their drugs to market.”
The investment was driven by demand for targeted gene therapies, such as cancer immunotherapies (CAR-T cells) and those for haemophilia, the firm said.
SAFC’s other biopharma GMP capabilities include a cell banking facility in Rockville, Maryland, and biomanufacturing near Glasgow, Scotland.
