WuXi Biologics, a world leader in biologics manufacturing
WuXi Biologics (“WuXi Bio”) (2269.HK), is a global company with leading open-access biologics technology platforms. With operations in Ireland, China, Germany and the U.S., our technology platforms and services are designed to help our global clients shorten the discovery and development time and lower the cost of biologics and vaccines using either microbial fermentation or mammalian cell culture production systems. Our global clients include over 450 global partners and 18 of the 20 largest pharmaceutical companies worldwide. Our vision:
“Every drug can be made and every disease can be treated” by building an open-access platform with the most comprehensive capabilities and technologies in the global biologics industry
Supported by our strong technical capabilities, extensive experience and state-of-the-art, open-access technology platforms WuXi Biologics allow its customers to initiate a project at any stage in the discovery and development process. We provide 6 biologics discovery platforms for lead identification and characterization, novel bispecific antibody and antibody drug conjugate engineering platforms, robust and novel cell line development technologies and advanced continuous bioprocessing/biomanufacturing platforms.
Our leadership team consists of one of the largest biologics R&D teams in the world including over 550 Ph.D. scientists with 15-20 years of experience working at the forefront of the biologics industry. While at WuXi Biologics, this team has enabled 8 BLA/MAA and over 172 worldwide IND submissions in just 6 years, including GMP manufacture of 4 commercial products. Our expertise covers all facets of drug development from early-stage discovery activities to GMP manufacture and release of final drug product. We enable our clients to develop a wide variety of biologics including monoclonal and bispecific antibodies, antibody drug conjugates, Fc-fusion proteins, enzymes, and other recombinant proteins. We also provide development and manufacturing platforms for virus and nucleic acid-based (e.g., plasmid and mRNA) therapeutics and vaccines. We offer comprehensive, integrated and highly customizable end-to-end services and solutions to empower organizations to discover, develop, and manufacture biotherapeutics and vaccines from concept to commercial manufacturing.
WuXi Biologics provides a quality system and operations that meet worldwide regulatory guidance. Our audit track record demonstrates our commitment to meeting worldwide regulatory standards as validated by GMP manufacturing accreditations from the U.S. FDA, EMA, NMPA, ANVISA and HSA.
Environmental protection, social responsibility and governance policies are priorities to WuXi Biologics. Our ESG committee is led by the CEO with a focus on pioneering and promoting green practices, giving back to local communities, and continuous improvement in corporate governance.WuXi Biologics has been well recognized for its good ESG performance by: MSCI, DJSI,FTSE Russel.
Our ESG programs include the following essential components:
- Strict compliance with the Environmental Protection Law and other EHS regulations
- Utilization of disposable bioreactors that consume 90% less water and energy and eliminate 100% of detergent use during cGMP production
- Facilities, equipment, and technologies that reduce emissions, waste,and consumption of resources.
The preservation of client IP is at the highest priority at WuXi Biologics and is the foundation of trust with our clients. We have established stringent policies in China and in the U.S. for the protection of intellectual property and prosecution of IP violations.
In addition to our core Biologics business, WuXi Biologics includes two subsidiaries each with a unique focus: WuXi Vaccines, for discovery, development, and manufacturing of vaccines, and WuXi XDC, a development and cGMP manufacturing for antibody drug conjugates and other bioconjugated therapeutics.
WuXi Biologics in Ireland
WuXi Biologics is investing €325 million in a new biopharmaceuticals contract manufacturing facility in Dundalk, Co. Louth. This new 45,000 sq. m. facility resides on 26-hectare site acquired in April 2018 and was supported by the Irish Government through IDA Ireland. Located mid-way between Dublin and Belfast, the facility is less than an hour’s drive from Ireland’s two largest cities. This area is an ideal location within easy reach of ten universities and higher education colleges, three international airports, intercity rail service, efficient motorways, deep seaports, and a strong bio-pharma ecosystem.
This highly significant investment will provide a valuable employment boost for the region, leading to the creation of 400 jobs when in full production (Scheduled for 2022). Career opportunitiesin Ireland will range from:
- Project Management
- Process Sciences
- Technical Services
- Commercial Manufacturing
- Quality Assurance
- Science & Chemistry functions
- Administrative and Logistics functions
- Regulatory functions
When completed, WuXi Biologics Ireland will become one of the world’s largest facilities using single-use bioreactor technology, a ‘Factory of the Future’ for commercial GMP manufacturing. The site will manufacture biologic drug substances on a round-the-clock basis, with the ability to quickly switch product lines in response to customer requirements. Using large volume, single-use bioreactors greatly enhance commercial manufacturing potential by allowing not only scale-out of capacity but also scale-up and flexibility for supplying multiple products and customers. In addition to the flexibility and time-to-market benefits of single-use manufacturing, clients gain economies of scale which can address their full range of biologics supply needs, from kilograms to tons.
By establishing this advanced facility in Ireland, WuXi Biologics will ensure that its innovative manufacturing technology is accessible to clients in Europe and around the world.
WuXi Vaccines and Ireland
WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development, and manufacture. An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based.
WuXi Vaccines is constructing a purpose-built vaccine manufacturing facility adjacent to the WuXi Biologics “Factory of the Future” in Dundalk, Ireland, with operations to commence in 2022. This integrated vaccine manufacturing facility with a 240 million US Dollar investment, will include drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner’s vaccine products for the global market. It will bring 200 additional new jobs to the Dundalk areaover the five years.