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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.
Sanofi and Boehringer Ingelheim (BI) announced on Jan. 15, 2015 that they are entering into an alliance with a focus on the manufacture of monoclonal antibodies (mAbs). Under the terms of the agreement, BI will handle the mammalian cell culture operations and contract manufacturing capacities for the products in Sanofi’s biologics pipeline.
BI’s contract manufacturing service offerings are now housed under their BioXcellence brand, which has already brought more than 20 biopharmaceutical products to market. The company set up the brand in 2012 specifically for its biopharmaceutical contract manufacturing business operations. According to a press release, BioXcellence is BI’s outsourcing arm, offering “tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish.”
Sanofi’s mAbs in development include various investigational agents for the treatment of solid tumors, non-Hodgkin’s lymphoma, CD38+ hematologic malignancies, and multiple myeloma. The company is also developing mAb-based therapies for indications outside of the oncology space. These include dupilumab, a fully-human monoclonal antibody for the treatment of atopic dermatitis and chronic sinusitis; alirocumab, an investigational monoclonal antibody targeting PCSK9 in hypercholesterolemia; SAR156597, an IL4/IL13 bispecific monoclonal antibody for the treatment of idiopathic pulmonary fibrosis; and The IL-6-receptor inhibitor sarilumab to treat rheumatoid arthritis. Many of the potential blockbuster biologics Sanofi has in the pipeline, such as dupilumab, alirocumab, and sarilumab, are slated to gain US regulatory approval in 2015.
Currently, BI is also working with XOMA Corporation for the commercial manufacture of gevokizumab, XOMA’s novel interleukin 1-beta (IL-1β) allosteric modulating antibody for the treatment of a wide variety of inflammatory diseases as well as with biopharmaceutical company Apexigen for the cell-line development and expression of APX005, a humanized mAb targeting CD40 for the treatment of cancers.
BI has facilities in Biberach, Germany; Vienna, Austria; Fremont, CA, USA; and Shanghai, China. In 2013, the company spent $45 million to build its cGMP biopharmaceuticals facility in Shanghai.