Biosimilar Manufacturing Update

Goodwin
Contact

Goodwin

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.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.