Mammalian Transient and Stable Expression

Transient expression in high-titer CHO and HEK 293 with speed and cost-effectiveness, transitioning seamlessly to CHO stable expression

Protein Sciences: Early-Stage R&D Mammalian Platform

Program Features:

WuXi Biologics’ industry-leading Protein Sciences (PS) Department produces high-quality proteins and antibodies to meet your schedule and requirements. No project is too large or small. Our team of experts can support the preparation of the most complex proteins or provide one to thousands of standard antibodies and proteins for your diverse needs, including early-stage research, lead candidate screening, immunizations, in vivo studies, biochemical assays, and other research purposes. Projects can be structured by using a FTE or FFS model to meet your project needs. Our labs feature high-throughput expression and purification systems to maximize efficiency.

Projects start from customer- provided amino acid sequence (with codon optimization), DNA sequence, or plasmids Deliver high-quality proteins suitable for most in vitro and in vivo studies Provide comprehensive QC data Expi293/HEK293 are default systems for non-antibody reagent proteins (non therapeutics) Utilize our efficient, proprietary, high-yielding WuXian TM CHO-K1 for antibodies and other therapeutic proteins NS0 are also used

Monoclonal Antibodies

ADC  Therapeutics

Bispecific Antibodies

Fc-fusion Proteins

FAB VHH ScFv

Complex mAb formats

Recombinant Proteins

Other Proteins:

• Intracellular • Secreted • Many tag options (his, flag, etc.) • Non tagged • Protein complex

• Antigens • Fc fusions • Cytokines (ILs, TNF, TGFβ, etc.) • Fab, scFv & VHH

• ECD of cell surface receptors • Membrane proteins • Miniprotein • sTCR, TCR-Ab & SCT

Transient Platform

Express Platform

Timeline

Expression

Features

Timeline Expression

Features

3-5 weeks 0.8 mL to 20 L transient

• Start from codon optimization or customer provided DNA • Deliver product and QC data after 1-2 step purification

6-7 weeks 20 mL to 100 L stable pool

• Start from codon optimization or customer provided DNA • Deliver product and QC data after >2 steps purification

• 4-7 days • 300 mg/L - 2 g/L • Cell: CHO, HEK293

• mAb/BsAb/recombinant protein • 96 DWP - 20 L • mg-g of protein for early discovery

• 4-6 weeks • Cell: CHO, HEK293, NS0 • 3.5 g/L

• mAb/BsAb/recombinant protein • 20 mL - 100 L • >5 g developability study and early CMC process development

Gene Synthesis 1-2 weeks

Transient Transfection & Fed-Batch 1 week

Purification and QC 1 week

Gene Synthesis 1-2 weeks

Electrotransfection & Seed Training 2-3 weeks

Fed-Batch 2 weeks

Purification and QC 1 week

High-throughput processes (up to 1,000 Ab/day) with up to 3-step automated purification is perfect for large-scale screening from AI-based designs. WuXian Transient provides high-yield, high-quality protein suitable for animal studies and other critical lead molecule assessment projects. WuXian TM Transient Platform

Popular Packages

Reference Yield

Timeline

QC

96 x 0.8 mL 24 x 3 mL

100-800 μg 0.5-2 mg

2 weeks 2-3 weeks 2-3 weeks

A280, Caliper (R/NR), and SEC-HPLC

20 mL

3-10 mg, average 4.5 mg after 2-step purification

<0.5 EU/mg endotoxin control, QC incl. Titer, A280, Caliper (R/NR) or SDS-PAGE, SEC-HPLC

400-1,000 mg RP-HPLC, bioburden, DSF, DSC, SPR, LC/MS, SEC-MALS, peptide mapping, glycan profiling, cIEF, CHO HCP, residual DNA, ELISA, Western blot, freeze thaw study, micro-developability testing 3 weeks

1 L Additional QC

WuXian TM Express Platform

If you need more than a few grams of protein (e.g., developability studies), stable pool expression via the WuXian Express Platform is ideal. Our stable pool easily produces high-quantity and high-quality protein in 5-6 weeks in a shaker flask, wavebag or bioreactor.

Popular Packages

Reference Yield

Timeline

QC

<0.5 EU/mg endotoxin control, QC incl. Titer, A280, Caliper (R/NR) or SDS-PAGE, SEC-HPLC

20 mL

20 mg

2-3 weeks

1 L - 25 L Additional QC

1 - 25 g RP-HPLC, bioburden, DSF, DSC, SPR, LC/MS, SEC-MALS, peptide mapping, glycan profiling, cIEF, CHO HCP, residual DNA, ELISA, Western blot, freeze thaw study, micro-developability testing 6-7 weeks

Comparable Product Quality of Different Scales

cIEF

GLYCAN

SEC_LC

SDS_CALIPER

100

100

0 20 40 60 80

0 20 40 60 80

50

50

0

0

Main Peak (%) HMW (%)

LMW (%)

200 L 1st-2,000 L 2nd-2,000 L Main Peak (%) Acidic Species (%) Basic Species (%)

200 L 1st-2,000 L 2nd-2,000 L G0 G0F Man5 G1F G2F

NR

R

200 L 1st-2,000 L 2nd-2,000 L

200 L 1st-2,000 L 2nd-2,000 L

Similar product quality is observed among different scales of WuXian Express (one transfection)

Learn more: Protein Sciences: Early-Stage R&D Mammalian Platform

About WuXi Biologics

WuXi Biologics is a leading contract research, development and manufacturing organization (CRDMO) that provides end-to-end capabilities to healthcare organizations worldwide. With operations in China, the United States, Ireland, Germany, and Singapore, we enable our partners to effectively and efficiently bring biologics and vaccines to patients worldwide through our comprehensive and high-quality drug development model.

The world’s leading global single-source platform from concept to commercialization.

wuxibiologics.com | info@wuxibiologics.com

5-9-2024

Page 1 Page 2

www.wuxibiologics.com

Powered by