Provider profile

WuXi Biologics.

Biologics CDMOs

WuXi Biologics documents cell line, process, analytical and drug product development and cGMP drug substance and aseptic drug product manufacturing for antibodies and recombinant proteins using mammalian and microbial systems, from preclinical to commercial supply. It lists manufacturing sites in China (Wuxi, Shanghai, Suzhou, Hangzhou, Hebei), New Jersey, Massachusetts, Ireland, Germany and Singapore.

Website: wuxibiologics.com (opens in a new tab)
Sources reviewed: November 4, 2026 · Source pages re-checked within 4 months
First published: November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Analytical development and QC testing4
Cell line development1
Clinical packaging and labeling11
Formulation development5Formulation development using the WuXiHigh 2.0 platform
GMP drug product manufacturing6
GMP drug substance manufacturing9
Lyophilization5,6Lyophilization cycle development; lyophilized drug product manufacturing stated for DP1, DP2 and other DP facilities
Process development1,2,3
Stability studies5,7
Technology transfer12

Platforms and methods

Mammalian cell culture1,8
Microbial fermentation13Microbial commercial manufacturing site in Chengdu stated as under construction; microbial fed-batch capacity listed at Hangzhou (MVP)
Single-use bioreactors9

Drug substance / drug product

Drug product6
Drug substance9

Development experience

Development stage

Commercial5Stated for drug product development services spanning early development to commercial manufacturing
Phase 15Stated for drug product development (first-in-human formulations)
Preclinical1,5Pilot-scale fill-finish for preclinical studies and IND-enabling CMC timelines

Modality

Antibody-drug conjugates5,10ADC assays and drug product formulation development; the ADC/bioconjugate CRDMO platform is offered through subsidiary WuXi XDC
Monoclonal antibodies2,8,9
Oligonucleotides5Listed only among formats supported for drug product formulation development
Recombinant proteins2,8
Vaccines5,11Stated for drug product formulation development and drug product fill-finish

Locations

China · Manufacturing site14Hebei province site (city not stated): 12 x 4,000 L single-use bioreactors, fed-batch drug substance; GMP operation since 2022
Chengdu, China · Laboratory14Protein science labs operational since 2022; microbial commercial manufacturing site stated as expected to complete GMP release in 2H 2026
Hangzhou, China · Manufacturing site14Two sites: MFG20 (single-use drug substance) and DP9 (vials); MVP site with MFG13/MFG14 (HEK293 and microbial drug substance) and DP8 (vials/PFS, LNP)
Shanghai, China · Manufacturing site14Fengxian: clinical drug substance (MFG17), drug product (DP14, DP15) and device assembly; Waigaoqiao FTZ: clinical drug substance (MFG3), cell line and process development; Lingang biosafety testing center
Suzhou, China · Manufacturing site14Suzhou Industrial Park: clinical drug substance (MFG21, MFG22) and drug product (DP11, liquid and lyophilized vials); separate biosafety testing center in Wuzhong District
Wuxi, China · Manufacturing site14Drug substance (MFG1, 2, 4, 5) and drug product (DP1, DP2, DP4, DP5, vials and PFS) with packaging center
Wuppertal, Germany · Manufacturing site14cGMP drug substance plant (MFG19, single-use) for monoclonal antibodies with QC labs
Dundalk, Ireland · Manufacturing site14Commercial drug substance (perfusion and single-use fed-batch) with QC release testing
Singapore, Singapore · Manufacturing site14Tuas CRDMO center described with designed drug substance and drug product capacities; operational status not stated ("expected to employ 1,500 people when fully operational")
Cranbury, United States · Manufacturing site14Process and drug product development, clinical and commercial drug substance (single-use, up to 2 x 2,000 L) and drug product (robotic vial/PFS filling)
Worcester, United States · Manufacturing site14Single-use drug substance manufacturing (6 x 6,000 L)

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

GMP / cGMP2,5

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

Available capacity, slot timing and scale for your next campaign
Recent experience with your specific modality and expression system or chemistry
Regulatory inspection history of the specific site that would manufacture your product
Technology-transfer approach, timeline and who owns the resulting process knowledge
Analytical and QC release testing done in-house versus subcontracted
Quality agreement terms, batch-failure responsibility and change-order mechanics

Choosing a CDMO: a practical guide

Evidence and sources

1Mammalian Cell Line Development Services (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
2WuXiUP – Continuous Manufacturing (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
3Process Development and Scale-Up (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
4State-of-the-Art Equipment and Methods (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
5Drug Product Development (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
6Commercial Drug Product Manufacturing Service (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
7Unlock Potency and Safety Data for Any Biologic (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
8Biologics Analytical Development Services (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
9Commercial Drug Substance (DS) Manufacturing (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
10Routine Analytical Testing Services (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
11Clinical Drug Product Manufacturing (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
12Clinical Drug Substance Manufacturing (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
13Microbial Manufacturing & Fermentation Services (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
14Locations & Facilities (opens in a new tab)WuXi Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

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