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WuXi Biologics operates multiple world-class GMP manufacturing facilities for the production of biologics. Utilizing mammalian cell culture, we are able to produce a wide variety of biologics including monoclonal and bispecific antibodies, fusion proteins, antibody drug conjugates and other recombinant proteins. Over 90,000L of bioreactor capacity is available (150,000L by the close of 2021) for both clinical trials and commercial drug substance supply, increasing to 430,000L by 2023. Clinical and commercial scale drug product GMP manufacturing is also available.
Implementing next-generation facility designs for multi-product facilities, a “scale-out” single-use bioreactor production scheme and continuous bioprocessing technologies, WuXi Biologics has become a leading global biologics supplier for our partners and clients. The success of our GMP operations is also due to our “truly ONE” concept to commercialization drug development platform and excellence in project execution.
To support scale-up development efforts and large-scale process or batch record verification/qualification activities, both Wuxi and Shanghai maintain pilot/non-GMP manufacturing facilities. The manufacturing runs conducted at these sites also provide drug supply for IND-enabling toxicology studies or other preclinical and CMC development activities. The Shanghai Pilot Plant capacity is 6 x 200L and 1 x 500 L single-use/disposable bioreactors, and the Wuxi city Pilot Plant maintains 3 x 250L single-use/disposable bioreactors.
Each WuXi Biologics manufacturing facility shares the same quality system, and each site maintains dedicated in-house supporting functions such as QC testing labs, GMP warehouse, bio-waste and wastewater treatment, utilities (e.g., HVAC, WFI, Clean Steam, etc.), process automation systems (e.g., Delta V + OSI Pi Historian) and two independent power lines and back-up diesel generators.
Designed and constructed based on United States, European Union and Chinese cGMP requirements, WuXi Biologics’ first GMP Drug Substance (DS) manufacturing facility is utilizing only single-use/disposable bioreactors that are available to serve projects on a campaign basis. This 220,000 sq. ft. facility has been fully operational since 2012.
The site received an Honorable Mention award at the Facility of the Year Awards in 2014 by the International Society for Pharmaceutical Engineering (ISPE). The MFG 1 facility obtained a “Drug Production License” issued by NMPA (China National Medical Products Administration) in September 2016; passed the U.S. FDA Pre-License Inspection in March 2018; and passed the EMA (European Medicines Agency) Pre-Approval Inspection in March 2019 for the production of a commercial biotherapeutic (both Drug Substance and Drug Product). Since 2019, this site has passed additional U.S. FDA, EMA and NMPA inspections.
Located just 700 meters down the street from the MFG 1 site, this 460,000 sq. ft. GMP manufacturing facility is compliant with global GMP standards. It has been operational since 2017 for both large-scale perfusion and fed-batch cell culture manufacturing. The total production capacity of MFG 2 makes this site the world’s largest manufacturing facility utilizing single-use/disposable bioreactor technology (30,000 liters). The MFG2 site has receive GMP accreditation from the U.S. FDA and NMPA. This is WuXi Biologics’ first manufacturing facility to utilize a “scale-out” approach for large-scale biologics production. To learn more about the advantages of our “scale-out” approach, click here.
Operations began in April 2018 for the MFG 3 site. This facility is a 200,000 sq. ft. state-of-the-art production plant, currently offering complete biologics development and manufacturing in one central location. This single-source paradigm helps streamline clinical development even further for our clients. The site holds the European Medicines Agency’s (EMA) certified cell banking facilities for our client’s clinical GMP manufacturing drug substance supply.
WuXi Biologics developed a new continuous manufacturing process called WuXiUP™, which combines intensified perfusion cell culture and a continuous direct product capture process. This new manufacturing platform has been implemented in MFG 3 for several projects. Additionally, the in-line condition and in-line dilution systems were introduced to the facility to boost the efficiency of production through new buffer preparation automation processes.
This world-class facility is in close proximity to our other manufacturing sites in Wuxi city. It is the first facility completed as part of a larger biotech hub/campus that will also feature new discovery, development and commercial-scale manufacturing. The manufacturing suites have been GMP-ready since July 2019. This site is the first GMP facility in China to use the industry’s largest disposable bioreactor (4,000L) and the site was inspected and is certificated by the EMA for GMP manufacturing.
The WuXi Biologics’ Manufacturing 5 facility (MFG 5) is one of the world’s largest drug substance facilities using single-use bioreactors. Located in the Mashan district of Wuxi, MFG 5 offers 753,000 sq. ft. of manufacturing, quality control, utilities and warehousing functions.
MFG 5 is designed to maximize operational flexibility. With WuXi Biologics’ unique scale-out approach, MFG 5 offers batch scale production ranging from 2,000 L to 36,000 L. MFG 5 has a total cell culture capacity of 60,000 L, making it one of the largest single-use bioreactor-based DS facilities in the world. This facility hosts two production lines: the 4k line with 9 x 4,000 L ABEC bioreactors and the 2k line with 12 x 2,000 L GE bioreactors.
The two production lines allow flexible batch scale manufacture and can match clients’ increasing and various supply needs.
GMP Manufacturing Available in 2022
These state-of-the-art “facilities of the future” will utilize the novel “scale-out” manufacturing approach that WuXi Biologics has pioneered, deploying multiple, single-use bioreactors for commercial biomanufacturing. The sites are also designed to run commercial-scale continuous bioprocessing.
When completed, this facility will represent one of the world’s largest facilities using single-use bioreactors. The manufacturing facilities will reside on a 26-hectare (~64 acre) site, just 45 minutes from Dublin and one hour from Belfast. It is the company’s first site outside of China.
Site construction began in late 2018 and development of the site is supported by the Irish Government through IDA Ireland.
GMP Manufacturing Available in 2022
The commercial manufacturing facility (MFG 8) with a 48,000 L bioreactor capacity, will be built to meet cGMP standards of the United States, the European Union and China. Besides serving global clients and being one of the largest single-use/disposable manufacturing sites in the world, the new integrated center will also support the Marketing Authorization Holder (MAH) system in China and address urgent needs of Chinese partners.
The MFG 8 site occupies 80,389 m2 and includes manufacturing, administration, warehouse, engineering and waste process facilities. The initial phase of the center will be operational in 2022.
GMP Available in 2023
This new manufacturing facility, supported by the Singapore Economic Development Board, will be the company’s first overseas site in Asia. The state-of-the-art facility will be built upon the novel approach of single-use bioreactors that WuXi Biologics has pioneered. It is also designed to run continuous bioprocessing, a next generation manufacturing technology, and the first to be implemented in Asia outside China. This facility will be designed to handle both clinical and small-volume commercial production. An early-stage bioprocess development lab will also be included at the site.
GMP Available in 2024
This state-of-the-art “facility of the future” will be built upon the novel approach of single-use bioreactors that WuXi Biologics has pioneered. It is also designed to run continuous bioprocessing, a next-generation manufacturing technology. This facility will handle both clinical and small volume commercial production. An early-stage bioprocess development lab will also be included.
GMP Available in 2023
This new 1.3 million sq. ft. center will include integrated drug development, as well as clinical and commercial manufacturing facilities. The new site will enable more projects to be conducted for our global partners, create more jobs for local talents and stimulate growth for the biologics industry in Chengdu as well as the entire biologics ecosystem in Southwest China.
NBI (New Business Initiative) viral platform can support the integrated CMC development and GMP manufacturing of viral vector based products like gene therapy vectors, oncolytic virus, and vaccines. NBI GMP facility has a 2,000 square meter clean production plant, which is constructed in accordance with BSL-II and cGMP standards. The process production area uses dedicated new wind system and a large number of disposable processes to support multiple product manufacturing simultaneously. The facility will be fully GMP released for use in Q1 2021. The maximum production scale is 2×1000 L, and the annual maximum production capacity can exceed 60 batches.
NBI (New Business Initiative) microbial platform can deliver integrated CMC package based on E. coli and yeast fermentation, and achieve from lab grade to GMP grade product need for both plasmids and proteins. Our PD lab has various scale (from 250ml high-throughput mini-fermenter to 3L, 5L and 14L) fermenter, to meet different client needs, and is able to deliver gram-level lab material generation. Our 110M2 HQ/GMP suite could support 10-50L fermentation and downstream purification. GMP manufacture facility has total 2000M2 clean rooms. In Phase I, a 30- 300L single-use scale production line is to be built; in Phase II, stainless steel fermenter production lines with max 2000L USP and DSP capacity will be built. A maximum production capacity of 160 batches per year could be achieved by then. Our process development platform in Hangzhou will be delivered by the end of 2020, and our Phase I GMP facility will be ready by Q2 2021.
GMP Available in H2 2021
This recently acquired 66,000 sq. ft. site in Cranbury, New Jersey, is located in a business park near other biotech companies such as Amicus and WuXi AppTec. It will be the first operational bioprocessing site in North America for WuXi Biologics. This site will contain both upstream and downstream process development laboratories and two suites of single-use bioreactors for clinical trial drug substance production. State-of-the-art analytical development and Quality Control (QC) labs for lot release and stability will also be available.
GMP Available H2 2021
This 30,000-square-meter state-of-the-art DS facility (MFG19), was acquired from Bayer in December 2020. The facility will maintain 3 x 1000L perfusion and 6 x 2000L fed-batch capacity with independent downstream suites. The site will further enhance WuXi Biologics’ Global Dual Source network for supply of vaccines and other biologics. Together with the Drug Product facility in Leverkusen (DP7), this new DS facility will be used for commercial manufacturing, allowing WuXi Biologics to meet clients’ increasing demand for outsourced manufacturing services.
GMP Available in H2 2021
WuXi Biologics acquired the state-of-the-art biologics manufacturing facility as well as its labor force from Pfizer China (“Pfizer”) in March 2021. This site immediately boosted the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands. The 50,000 sq. m. facility, GMP operational since 2018, includes DS capacities equipped with 2 x 2000L single-use bioreactors expandable to 4 x 2000L and DP capacities of vial filling (DP9) and pre-filled syringe (DP10).
GMP Available in H2 2021
WuXi Biologics acquired CMAB Biopharma Group in 2021, and renamed it as WuXi Biologics (Suzhou) as a wholly owned subsidiary of the company. With the acquisition, WuXi Biologics is building up drug substance facility MFG21, and drug product facility DP11 for liquid and lyophilization, to help expand the company’s global DS and DP capacity.