WuXi Biologics is a global Contract Research, Development and Manufacturing Organization (CRDMO) with leading open-access biologics technology platforms. We offer end-to-end solutions that enable our partners to discover, develop, and manufacture biologics and vaccines from concept to commercialization for the benefit of patients worldwide. Our company history and achievements demonstrate our commitment to providing a truly one-stop service offering and strong value proposition to our global clients. With business operations in the United States, China, Ireland, Germany and Singapore, WuXi Biologics offers clients and partners unprecedented capacities and capabilities. In addition, WuXi XDC and WuXi Vaccines, two subsidiaries of WuXi Biologics, offer end-to-end platforms for the development and manufacture of bioconjugates and vaccines, respectively.
Our single-source technology platforms cover a wide range of biotherapeutics and vaccines produced from either microbial fermentation systems or mammalian cell culture including monoclonal and bispecific antibodies, ADCs, fusion proteins and other recombinant protein therapeutics and viral-based vaccines. We offer 6 discovery platforms, complete in-house CMC development capabilities and over 262,000 L of single-use bioreactor capacity using our "scale-out" manufacturing paradigm. Multiple drug product facilities are available for both clinical and commercial drug product fills for liquid or lyophilized formulations in vials, and pre-filled syringes.
High quality, integrated CMC/CRDMO services combined with our extensive capacities (facilities, equipment, and manpower) allows our global customers to bring biologic therapeutics efficiently and cost-effectively through the entire development process and into the market faster than if using the traditional multi-vendor approach.
WuXi Biologics is currently conducting, on behalf of its clients and partners (as of January 2023), a total of 588 integrated projects, including 300 in pre-clinical development stage; 234 in early-phase (phase I and II) clinical development; 37 in late-phase (phase III) development; and 17 in commercial manufacturing. With a total estimated capacity of exceeding 580,000 liters for biopharmaceutical production planned after 2026, in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics provides its biomanufacturing partners a robust and premier-quality global supply chain network.
We have enabled 376 INDs and 37 BLA/MAA filings and spent the past 5 years fine-tuning our one-stop service offering to provide clients a routine 12-month DNA to IND program for multiple biologic product types. We provide 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, PDMA and HSA. WuXi Biologics offers unprecedented GMP manufacturing capacity and multiple Drug Product fill facilities around the world with global "Dual Source" manufacturing options.
Contact us today to learn about partnering opportunities.
Our single-source technology platforms cover a wide range of biotherapeutics and vaccines produced from either microbial fermentation systems or mammalian cell culture including monoclonal and bispecific antibodies, ADCs, fusion proteins and other recombinant protein therapeutics and viral-based vaccines. We offer 6 discovery platforms, complete in-house CMC development capabilities and over 262,000 L of single-use bioreactor capacity using our "scale-out" manufacturing paradigm. Multiple drug product facilities are available for both clinical and commercial drug product fills for liquid or lyophilized formulations in vials, and pre-filled syringes.
High quality, integrated CMC/CRDMO services combined with our extensive capacities (facilities, equipment, and manpower) allows our global customers to bring biologic therapeutics efficiently and cost-effectively through the entire development process and into the market faster than if using the traditional multi-vendor approach.
WuXi Biologics is currently conducting, on behalf of its clients and partners (as of January 2023), a total of 588 integrated projects, including 300 in pre-clinical development stage; 234 in early-phase (phase I and II) clinical development; 37 in late-phase (phase III) development; and 17 in commercial manufacturing. With a total estimated capacity of exceeding 580,000 liters for biopharmaceutical production planned after 2026, in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics provides its biomanufacturing partners a robust and premier-quality global supply chain network.
We have enabled 376 INDs and 37 BLA/MAA filings and spent the past 5 years fine-tuning our one-stop service offering to provide clients a routine 12-month DNA to IND program for multiple biologic product types. We provide 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, PDMA and HSA. WuXi Biologics offers unprecedented GMP manufacturing capacity and multiple Drug Product fill facilities around the world with global "Dual Source" manufacturing options.
Contact us today to learn about partnering opportunities.
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