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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.
SAFC announced two expansions to its facilities on May 12, 2015: One in St. Louis, MO-built to support the commercial-scale production of antibody-drug conjugates (ADCs)-and the expansion of an existing Carlsbad, CA location-developed to accommodate global demand for gene therapy production, cell banking, and testing.
The St. Louis ADC facility
The ADC facility in St. Louis is the first of its kind in North America, according to an SAFC representative, and is currently in validation stages. It is expected to be online and fully operational in the third quarter of 2015. The facility was designed to meet SafeBridge category 4 compound handling requirements for highly active or cytotoxic compounds.
The MO facility will support SAFC’s other developments in the ADC space, including SAFC’s ADC Express program for preclinical ADC and bioconjugation services, and its fill/finish capabilities for the final filling of ADC products via a partnership with Baxter BioPharma Solutions. Gilles Cottier, president of SAFC, said in a press release that the combined ADC offerings will give SAFC’s customers the ability to “seamlessly scale ADC production from preclinical to commercial phases” and will essentially serve as a one-stop shop for ADC development.
During a press event supporting a tour of the new facility in May 2015, Cottier said that SAFC is the only US-provider of commercial-scale ADCs, and noted that the ADC market is expected to continue its double-digit growth to $2.8 billion by 2018. Sunitha Baskaran, PhD, vice-president of R&D and marketing at SAFC, said during the event that SAFC is a qualified supplier for many of the ADCs that are currently on the market or in clinical settings. Cynthia Wooge, PhD, global strategic marketing at SAFC, specified that while there are variations in the number of reported ongoing ADC projects in the pipeline (some sources claim there are 120 projects; others say there are 148), SAFC is involved with almost half of those in the pipeline-from Phase I to commercial development-providing linkers, payloads, or conjugation services for those projects.
Only a few contract manufacturing organizations cover multiple steps in the ADC supply chain, asserts Wooge, and approximately 70–80% of ADC manufacturing is outsourced. She says that a typical ADC will have approximately 30 release specifications incorporating a large number of characterization assays, so there is a significant need in the market for these types of manufacturing capabilities.
Apart from ADCs, by 2018, Baskaran estimates that the company will be “integrally involved” with the development of seven of the top nine best-selling biologic products. Simply put, the company expects to supply critical raw materials and/or media to a majority of the manufacturers of top-selling biologic products in the US.
Expansion in California
The California expansion, driven by advancements in the targeted gene-therapy pipeline, will enable SAFC to offer fill/finish capabilities of viral products to its clients in the gene therapy, viral vaccine, and immunotherapy sectors. And in St. Louis, demand for commercial capacity made the expansion a necessity, said SAFC representatives.