The deal will see Boehringer-Ingelheim commercially manufacture monoclonal antibodies (mAbs) on behalf of the Paris, France-based Biopharma Giant from its mammalian cell culture site in Biberach, Germany.
“Sanofi signed a Master Service and Supply Agreement (MSA) for commercial contract manufacturing of monoclonal antibody Drug-Substance,” Sanofi spokesperson Flore Larger told Biopharma-Reporter.com. “The reserved capacity by Sanofi can be used for different development or commercial mAbs out of Sanofi or Sanofi-Regeneron-Alliance products.”
She added the choice of B-I was due to its track record in “the global Launch of more than 20 products in the past,” and the first product to be transferred to the facility in the coming weeks will be an mAb developed in collaboration with Regeneron.
On Monday, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for Sanofi and Regeneron’s mAb Praluent (alirocumab), for the treatment of patients with hypercholesterolemia.
Heidrun Thoma, a spokesperson from B-I, said the manufacturing contract was a boost for the firm’s third-party manufacturing BioXcellence Business (CMB).
“The BioXcellence Business (CMB) of BI is in the market for more than 20 years and is pursuing a growth strategy,” she told this publication. “In this context we are seeking long term partnerships with important strategic clients. The manufacturing alliance with Sanofi is a perfect fit between Boehringer Ingelheim and Sanofi.”
Sanofi’s biologics pipeline
According to Sanofi, 72% of its R&D pipeline is in biologics, with Larger telling us approximately 40% are mAbs.
“We have a strategy for Biologics established to realize the outstanding potential of Sanofi's biologics Pipeline,” she said, adding the firm’s strategy involves “investing in [its] own resources, partnering with Regeneron and building an agile internal and external manufacturing network.”
In related news, Sanofi has assigned a separate deal with contract manufacturing organisation Catalent this week to evaluate site selective payload conjugation in order to enhance antibody-drug conjugate (ADC) pharmacokinetics.
The work will be done at Catalent’s facility, in Emeryville, California, using the SMARTag technology recently acquired from Redwood Bioscience.