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Protein Sciences

One Stop Shop for Research Protein Generation

With multiple platforms for protein generation, we produce diverse research grade proteins and antibodies to fit your needs.

Protein Analytics

 

WuXi Biologics provides comprehensive testing for all aspects of your lead molecule to help you assess their molecules early on. From purity/impurity testing, structure characterization including mass spectrometry based protein ID and post translational modification analysis, to SPR/ELISA/cell-based activity assay, our protein analytics platform is there to help you triage/optimize your candidates efficiently and effectively as possible.

 

Mask Group 56

Micro Developability

Micro developability consists of a series of high-throughput assays routinely conducted in mature pharmaceutical companies. The assays allow lead molecules to be examined at earlier stage using minimal material. Most of the assays can be completed within 2 weeks using in total less than 1mg protein. This will allow molecules being advanced to next stage with greater chances of success. For small biotech companies, early micro developability result also allows more accurate valuation of their assets for any business opportunities.   

 

Pharmacokinetics (PK)-predicting Assays

A panel of high-throughput, sensitive and robust assays that examine physicochemical properties of mAbs and are predictive of PK profile

 

  • AC-SINS/HIC
    Evaluation of self-association tendency .

 

  • Baculovirus/DNA/Insulin ELISA
    Evaluation of charge-based/non-specific binding

 

  • FcRn Affinity
    Evaluation of clearance

 

  • Serum Stability
    Evaluation of half-life

AC-SINS (Affinity-Capture Self-Interacting Nanoparticle Spectroscopy)

  • High throughput, low concentration and purity requirement
  • Assessment of antibody’s propensity of self-association/ aggregation, viscosity etc.

WuXi Bio PS website

AC-SINS HIC Correlation

Baculovirus/DNA/Insulin ELISA

 

  • Assessment of non-specific binding of mAbs
  • Most sensitive assays to measure low-affinity charge-based interactions of mAbs
  • High throughput, low cost, robust

Group 1051

Molecular Assessment Service Details:

(Micro-Developability)

Service Item Description Duration Request A Quote
DSF for Tm, one (1) molecule

1. Sample requirements: protein samples amount >25 ug; concentration >0.1 mg/mL

 

2. Deliverables: protein melting temperature Tm

 2 weeks Request A Quote
AC-SINS for self-association, one (1) molecule

1. Sample requirements: antibody samples amount >20 μg; concentration >0.5 mg/mL

 

2. Deliverables: wavelength shift compared to blank AuNP; self-association score

 2 weeks
HIC HPLC for self-association, one (1) molecule

1. Sample requirement: antibody samples amount >50 μg; concentration >0.5 mg/mL

 

2. Deliverables: hydrophobicity of the sample and the correlation with AC-SINS data (if applicable)

 2 weeks
Particle size by DLS (DLS-Radius)

1. Sample requirement: antibody samples purity >95%, concentration >1.5 mg/mL, 100 μL

 

2. Deliverables: particle size distribution

 2 weeks
Solubility check and predication (DLS-kD & Appearance inspection)

1. Sample requirement: antibody samples purity >95%, amount >4 mg; concentration >0.5 mg/mL

 

2. Deliverables: kD

 2 weeks

Optional: High concentration study with viscosity, one (1) molecule

Note: least 100 mg materials will be needed.

1. Sample requirement: antibody samples volume >50 μL; concentration based on needs

 

2. Deliverables: viscosity at designated concentrations

 2 weeks
Baculovirus ELISA, one (1) molecule

1. Sample requirement: antibody samples amount >250 μg; concentration >0.5 mg/mL

 

2. Deliverables: titration curve and baculovirus binding score

 2 weeks
DNA ELISA, one (1) molecule

1. Sample requirement: antibody samples amount >250 μg; concentration >0.5 mg/mL

 

2. Deliverables: titration curve and DNA binding score

 2 weeks
Insulin ELISA, one (1) molecule

1. Sample requirement: antibody samples amount >250 μg; concentration >0.5 mg/mL

 

2. Deliverables: titration curve and insulin binding score

 2 weeks
FcRn binding assay, one (1) molecule

1. Sample requirement: antibody samples amount >20 μg; concentration >0.5 mg/mL

 

2. Deliverables: association profile at pH 6.0, dissociation profile at pH 6.0 and pH 7.4; KD fitting for pH 6.0 (if applicable)

 2 weeks
FcγRI/FcγRII/FcγRIII binding assay one (1) molecule

1. Sample requirement: antibody samples amount >20 μg; concentration >0.5 mg/mL

 

2. Deliverables: binding profile and constant

 2 weeks
Serum cleavage assay, one (1) molecule

1. Sample requirement: antibody samples amount >100 μg; concentration >0.5 mg/mL

 

2. Deliverables: protein cleavage percentage and/or cleavage sites

 2 weeks

 

Preliminary Stability Assessment Service Details:

(example stability protocol)

Test Low PH Hold Free/Thaw (3X/5X cycles) Thermo 40C (1W/2W)
  To End To End To End
ICIEF Optional Optional Optional Optional X X
SEC Optional X Optional X X X
Caliper NR Optional Optional Optional Optional X X
Caliper R Optional Optional Optional Optional X X
MS Intact Optional Optional Optional Optional X X
CE-MS (optional) Optional Optional Optional Optional X X
MS Peptide Map (optional) Optional Optional Optional Optional X X

Stage III Molecular Assessment Service Details:

(Developability for Top Candidate)

Service Item Sample No. Analytical Testing Duration Request A Quote
Protein size determination 1 sample/molecule, 3 samples in total CE-SDS (R and NR) 1 week Request A Quote
Protein ID determination 1 sample/molecule, 3 samples in total Intact MS analysis (includes R (with/without degly) and NR (degly)） 1-2 weeks
Post-translational modification analysis 1 sample/molecule, 3 samples in total MS analysis 2-3 weeks
Antibody self-interaction assessment 1 sample/molecule, 3 samples in total AC-SINS 1 week
Antibody self-interaction assessment 1 sample/molecule, 3 samples in total HIC 1 week

LC-MS Services

  • Detailed characterization of bispecific antibody by intact mass analysis
  • High-throughput intact mass analysis for protein confirmation and quick glycan analysis (96-well plate)
  • Detailed peptide mapping for sequence coverage, PTM, sequence variant analysis
  • Disulfide mapping analysis to determine unknown disulfide linkage
  • N-glycan analysis by LC-Fluorescence-MS/MS for complex glycosylation

 

Intact Mass LC-MS Service Details:

(For Protein Samples)

Service Item Description Quantity Test Window Request A Quote
Intact mass LC-MS
(simple protein & vanilla antibody）

1. Sample and sequence requirement: sample amount >20 μg, concentration >0.5 mg/ml1

 

2. Sample preparation: reduce/non-reduce; degly/without degly option provided

 

3. Deliverables:

 

  1. Confirm protein sequence: main peak ID
  2. Check sequence homogeneity: >10% (MS intensity%) minor impurity ID
 1-10 samples <1 week Request A Quote 
11-20 samples 1-2 weeks
>20 samples 2 weeks
Intact mass LC-MS
(protein with more than 2 glycosylation sites & bi-,tri-specific and fusion protein）

1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1

 

2. Sample prep: reduce/non-reduce option provided

 

  1. Unique deglycosylation protocol to remove complex glycan and reduce heterogenicity if necessary

 

3. Deliverables:

 

  1. Confirm protein sequence: main peak ID
  2. Check sequence homogeneity: >10% (MS intensity%) minor impurity ID
 1-10 samples <1 week
11-20 samples 1-2 weeks
>20 samples 2 weeks

High-throughput protein ID by intact mass LC-MS

(96 well plate antibody confirmation)

 

1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1

 

2. Sample prep: reduce/non-reduce option provided

 

  1. Unique deglycosylation protocol to remove complex glycan and reduce heterogenicity if necessary

 

3. Deliverables:

 

  1. Confirm protein sequence: main peak ID
  2. Check sequence homogeneity: >10% (MS intensity%) minor impurity ID
 <50 samples <1 week
50-96 samples <1 week
MS spectrum and peak list only

1. Sample and sequence requirement: sample amount (96 well plate format) >20 μg, concentration >0.5 mg/ml1

 

2. Sample prep: reduce/non-reduce; degly/without degly option provided

 

3. Deliverables: MS spectrum and peak list only

 No limit 2 days

 

Note:
1. For sample amount and concentration lower than specified requirement, please consult with BD
2. For other special needs, please consult with BD

Peptide Map LC-MS Service Details:

(For Protein Samples)

Service Item Description Quantity Test Window Request A Quote
Peptide mass analysis
(Mass ID confirm）

1. Sample and sequence requirement: sample amount >30 μg, concentration >0.5 mg/ml1

 

2. Deliverables:

 

  1. Confirm protein sequence: sequence coverage map
 1-3 samples 1 week Request A Quote 
3-5 samples 1-2 weeks
>5 samples 2-3 weeks
Peptide mass analysis
(Based on software）

1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1

 

2. Deliverables:

 

  1. Confirm protein sequence: sequence coverage map
  2. Software-based identification for PTM, SV and fragment et al analysis.
 1-3 samples 1 week
3-5 samples 2 weeks
>5 samples 2-3 weeks

Peptide mass analysis
(Based on software & manual check）

 

1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1

 

2. Deliverables:

 

  1. Confirm protein sequence: sequence coverage map
  2. Check sequence homogeneity: software-based identification for PTM, SV and fragment et al analysis.
  3. Check sequence homogeneity: manual check for all components with user defined intensity threshold (>1%) for detailed PTM, SV and fragment et al analysis
 1-3 samples 2 weeks
3-5 samples <2 weeks
>5 samples <2-3 weeks

 

Note:
1. For sample amount and concentration lower than specified requirement, please consult with BD
2. For other special needs, please consult with BD

Disulfide LC-MS Service Details:

(For Protein Samples)

Service Item Description Quantity Test Window Request A Quote
Disulfide mapping analysis
(To confirm known disulfide linkage）

1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1

 

2. Deliverables:

 

  1. Confirm known disulfide linkage information
  2. Report free cysteine amount and any mis-linked disulfide bond with >5% abundance2

 

 1-3 samples 1-2 weeks Request A Quote
3-5 samples 2 weeks
>5 samples 2-3 weeks
Disulfide mapping analysis
(To determine unknown disulfide linkage）
  1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1

 

2. Deliverables: determine unknown disulfide linkage for every cystein

 1 sample 2 weeks

 

Note:
1. For sample amount and concentration lower than specified requirement, please consult with BD
2. For user-defined threshold and any other special needs, please consult with BD

N-glycan LC-MS Service Details:

(For Protein Samples)

Service Item Description Quantity Test Window Request A Quote
N-glycan analysis

1. Sample and sequence requirement: sample amount >100 μg, concentration >0.5mg/ml1

 

2. Deliverables:

 

  1. Report any glycan relative abundance >1% based on fluorescence2
  2. Report glycan ID based on mass spec results

 

 1-5 samples 2 weeks   Request A Quote  
>5 samples 2-3 weeks

 

Note:
1. For sample amount and concentration lower than specified requirement, please consult with BD
2. For user-defined threshold and any other special needs, please consult with BD

LC-MS Based Protein Quantification Service Details:

Service Item Description Quantity Test Window Request A Quote
N-glycan analysis Pilot testing for feasibility evaluation and experimental protocol set up (including 5 sample testing) 1 sample 2 weeks Request A Quote  
Protein quantification without enrichment step 1-10 samples 2 weeks
10-30 samples 2 weeks
>30 samples 2 weeks
Protein quantification with affinity enrichment step 1-10 samples 2 weeks
10-30 samples 2 weeks
>30 samples 2 weeks

 

Note: Intact mass analysis

Purity and Impurity Test

WuXi Biologics evaluates the physicochemical characteristics of proteins using a variety of analytical methods to elucidate the identity, structure and purity of the product.

 

Product related impurities including size variants can be evaluated by orthogonal analytical methods including CE-SDS and size exclusion chromatography (SEC) with both UV and multi-angle light scattering (MALS) detectors, while charge variants can be evaluated using ion exchange HPLC (IEX-HPLC) and imaged capillary isoelectric focusing (icIEF). Process-related impurities such as host cell protein, host DNA, and protein A can also be routinely tested to ensure contamination control.  Finally, high-throughput endotoxin testing is also available for microbial control.

Routine Protein Production Analysis Service Details:

Service Item Description Assay Test window Request A Quote
Purity/Impurity Test Product related impurities (Size/Charge variant tests) iCIEF 1 week  Request A Quote
SEC 1 week
HIC-HPLC 1 week
RP-HPLC 1 week
NR CE-SDS (Caliper) 1 week
R CE-SDS (Caliper) 1 week
Process related impurities HCP-ELISA 1 week
rDNA (qPCR) 1 week

 

Note: For other special needs, please consult with BD

Protein Stability Service Details:

Service Item Description Assay Test window Request A Quote
Purity/Impurity Test Product related impurities (Size/Charge variant tests) iCIEF 1 week  Request A Quote
SEC 1 week
HIC-HPLC 1 week
RP-HPLC 1 week
NR CE-SDS (Caliper) 1 week
R CE-SDS (Caliper) 1 week

Surface Plasmon Resonance (SPR)

SPR is an optical technique used to measure molecular interactions in real time. SPR can occur when plane-polarized light hits a metal film under total internal reflection conditions.

Benefits of SPR:

  • Versatile: capable of detecting most types of molecules
  • Wide range: analyze from μM to fM binder

 

We offer:

Bio-Layer Interferometry (BLI)

BLI is also a real-time, label-free optical technique that measures variations in optical thickness at the surface of a biosensor through interference created by the reflection of a light beam on the surface of the biosensor and on the surface of the biomolecular layer. The signal strength is proportional to the size of the molecule bound to sensors

 

Applications of BLI/SPR