Biosimilar Manufacturing Update

On March 25, 2021, biosimilar manufacturer mAbxience announced that it is expanding its León, Spain manufacturing facility with a new 4,000 L Custom Single Run (“CSR”) bioreactor.  mAbxience claims its León plant is “the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in most processes.”  The new 4,000 L single-use bioreactor system is expected to be installed in the coming months, which, according to mAbxience, “will significantly increase biosimilar and CDMO manufacturing capacity.”

On March 17, 2021, WuXi Biologics, a Chinese biologics company, announced that it entered into an equity agreement with Pfizer China to acquire Pfizer’s biologics manufacturing facilities and labor force in Hangzhou, China.  XuWi indicated that the transaction is expected to close in the first half of 2021, and “will immediately boost the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands.”  The GMP facility has been operational since 2018.  According to WuXi the facility “includes DS capacities equipped with 2x2000L single-use bioreactors expandable to 4x2000L (MFG20) and DP capacities of vial filling (DP9) and pre-filled syringe (DP10).”  Dr. Chris Chen, CEO of WuXi Biologics, commented, “We are pleased to work with Pfizer and add the new Hangzhou biologics manufacturing facilities to our global network to address the surging manufacturing demands for late-stage and commercial projects due to the success of our Win-the-Molecule strategy. Globally DS and especially DP capacities are in urgent need now. The acquisition will allow us to better enable our global partners to develop and manufacture premier-quality biologics to benefit patients around the world.”