Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish




Antibody Drug Conjugates

Technologies & Platforms

Our custom protein generation services group utilizes a variety of technologies to generate high-quality antibodies, recombinant proteins and cell lines for early stage drug screening and lead selection, assay development, structure analysis and other research purposes. Our team has extensive experience with various types of proteins, including monoclonal antibodies, bi-specific antibodies, kinases, proteases, cell surface receptors, cytokines, metabolic enzymes, nuclear receptors, DNA binding proteins and viral envelope proteins.

Research Grade Protein Expression and Purification

At WuXi Biologics we use CHO and HEK293 cells, E. coli, yeast and a baculovirus-mediated insect cell expression system to produce antibodies, Fc-fusion and other recombinant proteins to support various research purposes. Equipped with state-of-the-art purification systems, WuXi Biologics’ experienced team purifies antibodies and proteins with high-purity and low endotoxin levels in a fast and cost-effective way. Table 1 provides an overview of our expression and purification systems and analytical technologies we routinely use for protein generation.

In particular, we leverage WuXi’s proprietary vectors and CHO K1 cell line to provide clients milligram-to-gram scale high-quality, purified mAbs or recombinant proteins in 3-9 weeks. Based on production requirements, timelines and budget, WuXi provides transient production, fast stable pool production or traditional stable pool production services to meet our clients’ exacting needs. See Table 2 below for a complete guide of the three protein production options.

Additionally we could also perform:

  • Quick evaluation of in vitro binding and thermostability of mAb candidates in 24 deep well plate
  • In vitro and in vivo study of mAb candidates and quick developability assessment using transiently produced materials
  • In-depth developablility and exploratory tox studies of mAbs/recombinant proteins produced by stable pool production
Table 1
Expression Systems E. coli, yeast, insect (baculovirus) and mammalian cells (HEK 293, CHO-S and CHO-K1)
Purification Systems Affinity, ion exchange, HIC, SEC and endotoxin removal columns
Protein Characterization SDS-PAGE / IEF, protein determination, UV spectrophotometry, western blot, gel filtration, mass spectrometry, isothermal titration, calorimetry, biochemical and endotoxin tests/assays
Service Options Transient expression, fast stable pool production and traditional stable pool production

Fast Stable Pool Production

Fast Stable Pool (FSP) production is designed to fill the gap between transient production and traditional stable pool methodologies. Compared to transient production, which does not have the gene integrated into the genome, FSP does incorporate the target gene into host cell chromosome, and delivers significantly more material yet only adds 1 week to the overall timeline. Compared to the traditional stable pool production, FSP eliminates the pool selection step and thus offers significant cost savings for the same scale and eliminates 6 weeks from the overall timeline! FSP is ideal when the cell line is not needed for later use and you need over 500mg purified protein or antibody to be delivered as soon as possible. See a side-by-side comparison of the three services in Table 2 to help you decide which option to use. Below are some common applications for materials obtained from FSP production:

  • Feasibility study for recombinant proteins or bispecific antibodies (more representative than transient products)
  • In vivo and in vitro study
  • Developability study
  • Purification, formulation and analytical method development
Table 2. A comparison of three service options
Service Options Production Speed Yield Per Liter Total Cost Cost Per mg Cell Line Retention Ideal Production Scale
Transient Expression 5 weeks 140 mg/L NO <500mg
Fast Stable Pool 6 weeks 1,500 mg/L NO 500mg-3g
Traditional Stable Pool 12 weeks 2,000 mg/L YES >3g

Assay Cell Line Generation

We offer several standard parental cell lines from different species (Table 2) for assay development or evaluation of drug candidates. In addition to plasmid expression systems with various selection markers, we also provide virus-mediated expression service. All expression vectors provide the option to use tags for expression identification.  We offer dozens of combinations of parameters that can be optimized for successful and stable target expression and maintenance. We use standard FACS as well as Mirrorball for clone identification. These rapid HTS cell-based screening tools allow us to improve the success rate or your program in shorter time.

Table 3
Parental Cell Lines HEK 293; Ba/F3; C6; CHO
Vector Systems pcDNA3.3; pDisplay™; pLEX; pLENT; Tags could include V5, c-myc, Flag
Transfection Lipid mediated; Electric transfection; Virus-mediated
Screening Methods FACS; Mirrorball®