SAFC Expands For Drug Conjugates

By midyear, the lab products supplier Sigma-Aldrich will be part of Germany’s Merck KGaA. But for now, it’s business as usual, especially at Sigma-Aldrich’s SAFC custom manufacturing business. With $700 million in 2014 sales, 25% of the firm’s total, SAFC has been Sigma-Aldrich’s fastest-growing segment for most of the past five years.

At an SAFC press event last month in St. Louis, Merck’s pending acquisition of Sigma-Aldrich was the elephant in the room. Little information about the future of the merged company was offered, other than assurances that the deal is on track.

SAFC President Gilles Cottier was upbeat about what his business has been achieving and said it will continue to do the same “when we are together with Merck.” Last year when the merger was announced, the companies described a combination of largely complementary offerings in biopharma production, SAFC’s main market.

Overall, SAFC is active in custom pharm­aceutical chemical manufacturing, ingredients and services for biologic drug production, and materials for the electronics industry.

But its recent investment focus has been on building technology in the three areas of antibody-drug conjugates (ADCs), gene and cell therapy, and gene-editing and cell line development, Cottier said. In assembling the pieces, he added, SAFC seeks to create “an ecosystem of products and services” to help customers develop and make drugs.

The technologies SAFC is pulling together are typically applied in the development and manufacture of biotech drugs, a rapidly growing area in which therapies are becoming increasingly complex to manufacture. SAFC loves complex challenges “because we can leverage our science and our technical knowledge,” Cottier said.

Chief among the challenges are ADCs. Now largely targeting cancer, ADCs generally consist of a cytotoxic drug payload chemically linked to a disease-targeting monoclonal antibody. This multicomponent construct requires the handling of biologics, potent compounds, linker chemistry, and advanced analytics. Manufacturing tends to be done by specialized contract firms with one or a few of these capabilities.

With 70–80% of ADC production outsourced by drug companies, the contract manufacturing market should exceed $1 billion per year in the coming decade, according to Roots Analysis, a London-based market research firm. But having to work with separate contract suppliers only adds to the complexity. “One-stop shops are a rarity in this field,” Roots points out.

For the past decade, SAFC has been moving toward becoming one of this rare breed. For biologic drug manufacturing, it provides cell line development and supplies powdered cell culture media from U.S. and European plants. At a facility in Madison, Wis., the firm synthesizes cytotoxic payloads and linkers and plans to soon expand R&D there. In April, SAFC launched a program for preparing and characterizing small amounts of ADCs for customers’ preclinical work.

At the press event, SAFC debuted an expansion of its St. Louis facility, where it already conducts clinical-scale conjugations, to offer large-scale manufacturing. The plant makes SAFC the only commercial-scale ADC supplier in North America, Cottier claimed. To complete the picture, in late 2014 the firm began working with Baxter BioPharma Solutions, which will provide sterile drug filling and finishing services.

The ADC drug market is expected to reach $10 billion by 2024. At least 160 products are in preclinical and clinical development, said Cynthia Wooge, SAFC’s global strategic marketing manager. Of the three approved and 54 in the clinic, SAFC is involved in 27 of them.

The linker, payload, and biologic portions of ADCs, especially newer ones at the preclinical stage, are evolving, Wooge said. And many ADC development programs are getting fast-tracked by regulators. “It’s an exciting time to be in this field,” she added.

SAFC is looking beyond ADCs at other bioconjugates and at building on its other “ecosystems.” In April, Sigma-Aldrich opened a cell culture technical center in Singapore.

And last month, SAFC said it would expand a facility in Carlsbad, Calif., so it can offer clinical- and commercial-scale production of viral products for customers in the coming hot areas of gene therapy, viral vaccines, and immunotherapy. Cottier and his team no doubt expect to be pursuing those markets in the years ahead when SAFC and Sigma-Aldrich are part of a German company called Merck.