WuXi Biologics
Offering End-to-End Solutions
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.
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 (Affinity-Capture Self-Interacting Nanoparticle Spectroscopy)
AC-SINS HIC Correlation
Baculovirus/DNA/Insulin ELISA
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
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:
|
1-10 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
3. Deliverables:
|
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
3. Deliverables:
|
<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:
|
1-3 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:
|
1-3 samples | 1 week | |
3-5 samples | 2 weeks | |||
>5 samples | 2-3 weeks | |||
Peptide mass analysis
|
1. Sample and sequence requirement: sample amount >50 μg, concentration >0.5 mg/ml1
2. Deliverables:
|
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:
|
1-3 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) |
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:
|
1-5 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:
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
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