WuXi Biologics to Acquire Pfizer China’s Biologics Manufacturing Facilities
WuXi Biologics announced on March 17, 2021 that it has entered into an equity agreement with Pfizer China to acquire its biologics manufacturing facilities and labor force in Hangzhou, China.
The 50,000-m2 facilities feature drug substance (DS) capacities, which include 2 x 2000-L single-use bioreactors expandable to 4 x 2000-L (MFG20) and drug product (DP) capacities of vial filling (DP9) and pre-filled syringe (DP10), WuXi said in a company press release. The transaction is set to close during the first half of 2021 and is expected to enhance DS and DP capabilities for WuXi.
“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,” said Chris Chen, CEO of WuXi Biologics, in the press release. “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.”
BioVaxys Enters Major Bioproduction Agreement With Wuxi Biologics (Hong Kong) Ltd. To Synthesize Proteins For Its SARS-CoV-2 Vaccine And COVID-T™ Immunodiagnostic Programs
BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: LMNGF) (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it has entered into a major bioproduction agreement with WuXi Biologics Limited (“WuXi”), a leading global Contract Development and Research Organization (“CDMO”) and business unit of Shanghai-based Wuxi AppTec, to produce SARS-CoV-2 s-proteins required by BioVaxys for BVX-0320, its COVID-19 vaccine candidate, and for its Covid-T™ immunodiagnostic program.
Under the terms of the March 11th, 2021 agreement, WuXi will synthesize high yields of fully characterized, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein for BioVaxys’ preclinical safety study of its COVID-T™ diagnostic this spring. The recombinant s-protein will be constructed and expressed using WuXi Biologics’ proprietary vector, with high yield protein production in a pilot plant bioreactor. By establishing its own source of s-protein, rather than depending upon a bulk commercial supplier, BioVaxys will be able to secure the level of purity, consistency and protein characterization required by the U.S Food and Drug Administration (“the FDA”), as well as the economics of sourcing its own protein supply, facilitating the future production of GMP-grade s-protein for human trials and future commercial-scale production.
Synthesized GMP-grade s-protein is used in both BioVaxys’s Covid-T™ immunodiagnostic as well as in BVX-0320, the company’s SARS-CoV-2 candidate vaccine which is also being prepared for a clinical study this year. BioVaxys will submit its pre-IND meeting request to the FDA for Covid-T early next month.
BioVaxys President and Chief Operating Officer Ken Kovan stated that “Establishing a bioproduction method for a steady supply of purified and fully characterized s-protein from a validated process will enable us to quickly transition from having the GLP material for the upcoming Covid-T™ animal toxicity study to having a steady source the GMP-grade s-protein for clinical trials later this year. Now that we know the gene sequences, a further major benefit of our relationship with WuXi will be our ability to quickly source the s-protein of newly emerging SARS-CoV-2 variants for use in a planned multi-valent version of BVX-0320 and line extensions of Covid-T™.”
James Passin, BioVaxys CEO, stated “We are delighted to execute a definitive agreement with WuXi Biologics, a leading China-based CDMO listed on the Hong Kong Stock Exchange under the symbol 2269, with a market capitalization of USD$45 billion. The relationship with WuXi positions BioVaxys to accelerate the regulatory and commercial advancement of Covid-T™ and BVX-0320.”
For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.