WuXi Biologics
Offering End-to-End Solutions
The Analytical Sciences (AS) department provides a broad range of analytical services for biologics development including:
In addition, AS helps, along with our biologics Discovery R&D teams, to identify the final lead drug candidates by testing multiple candidates for quality, stability and developability/manufacturability, thus reducing the risks for the subsequent CMC development process.
A typical developability study includes the following aspects:
We provide a comprehensive range of assays to detect process-related impurities. Listed below are examples of impurity detection assays previously developed and validated by the WuXi Biologics Process Related Impurity Detection Center of Excellence. This list is not all-inclusive of all assays developed by the Center of Excellence. Contact us to learn more.
# | Impurity | Detection Method | LOQ |
---|---|---|---|
1 | 2-Fluorotrehalose (2FF) | UPLC-FLD | 0.166 μg/mL |
2 | Antifoam C (Simethicone) | UPLC-ELSD/UPLC-CAD | 2.0 μg/mL |
3 | Aurein tricarboxylic acid (ATA) | UPLC-UV | 0.5 μg/mL |
4 | Benzyl alcohol | HPLC-UV | 1.0 ppm |
5 | b-Glucan | ELISA | 3.125pg/ml |
6 | Blasticidin S | UPLC-UV | 5.0 ng/mL |
7 | Dextran Sulfate | UPLC-UV | 2 μg/mL |
8 | Ethylene Glycol | GC-MS | 2.5 μg/ml |
9 | Ethanol | GC-MS | 5ppm(v/v) |
10 | N-Acetylglucosamine (GlcNAc) | UPLC-FLR | 0.05 μg/ml |
11 | Guanidine hydrochloride (GnHCl) | HPLC-UV | 3.0 μg/ml |
12 | Imidazole | UPLC-UV | 0.1 μg/mL |
13 | Insulin | ELISA | 5.25 mU/L |
14 | Kanamycin | UPLC-CAD | 2.0 μg/ml |
15 | LR3 IGF-1 | ELISA | 3.9ng/ml |
16 | Methionine sulfonate (MSX) | UPLC-UV | 0.1 μg/mL |
17 | Methotrexate (MTX) | UPLC-UV | 4.0 ng/mL |
18 | pAF | HPLC-UV | 0.025 μg/mL |
19 | pDADMAC | UPLC-ELSD | 3.0 ppm |
20 | PEG 6000 | HPLC-CAD | 10 μg/ml |
21 | PF68 (Poloxamer) | UPLC-ELSD | 2.0 μg/mL |
22 | PMSF | HPLC-UV | 1.0 μg/ml |
23 | Propylene Glycol | HPAEC-PAD | 0.5 μg/mL |
24 | Sodium Caprylate | UPLC-UV | 2 μg/mL |
25 | Tri-n-butyl phosphate (TnBP) | GC-MS | 0.05ppm(v/v) |
26 | Triton X-100 | HPLC-UV | 0.125 μg/mL |
27 | Urea | HPLC-FLD | 0.5 μg/mL |
28 | Uridine | HPLC-UV | 0.6 μg/ml |
29 | Zeocin | UPLC-UV | 0.2 μg/mL |
See the table below for examples of our extensive analytical methodologies and instruments used to support our discovery and development services. In addition, working with our experts in Drug Product Development (DPD), the analytical teams leverage world-class instrumentation to perform product characterization and mechanical testing in support of drug product process evaluations, formulation development and contain closure system (CCS) assessments. Specialized equipment and methods supporting DPD can be found here.
Quantity
|
UV280 Protein Content |
Compendial
|
General: Appearance, Color, Clarity, pH, Osmolality Particles: Visible Particles, Subvisible Particulate Matter Biosafety: Sterility, Bioburden, Endotoxin |
Biochemical
|
Impurities: HCP, Residual Protein A, Residual DNA |
Physicochemical
|
Aggregation: SEC Fragment: Reduced/Non-Reduced CE-SDS Charge Variants: cIEF, AEX, CEX |
Biophysical
|
CD, FTIR, DSC, SEC-MALS, AUC |
Biological
|
ELISA or Cell-Based Antigen-Binding (ELISA, SPR, FACS, ECL etc.) Fab/Fc Function (ADCC, CDC, FcγR/ FcRn) |
Process Related Impurities
|
Anti-foam C, Benzyl alcohol, Dextran Sulfate, MSX, MTX, PF68, PEG 6000, PMSF, TnBP, Triton X-100, Urea |
We follow appropriate testing procedures that comply with CP, USP and/or EP for each integrated project depending on its filing region.
For information on our compendial mycoplasma assays and other non-compendial biosafety tests (e.g., adventitious virus), click here.
We offer biochemical analysis services for the identification, detection and quantitation of process-related impurities/contaminants, as part of an integrated package and as standalone projects with rapid turnaround. We offer platform methods and our team is experienced in managing biochemical methods throughout the lifecycle of development/optimization, transfer, qualification and sample testing. The following list illustrates some of our platform biochemical analysis capabilities.
We provide biophysical techniques for probing the higher-order structural integrity and for full product characterization. The tests include secondary and tertiary structure analysis, thermal stability, and molecular weight distribution.
Assessment of the biological properties constitutes an essential step in describing the specific ability or capacity of a product to achieve a defined biological effect. We offer biochemical assays, cell-based assays and other ligand/receptor-binding assays to measure the biological activity and explain the correlation between the expected clinical response and the biological assays.
Following the unique properties of the molecule, WuXi Biologics Analytical Sciences (AS) team offers a full set of analytical methods leveraging physical-chemical, biological, higher-order structural, and protein structural analytical technologies. AS has extensive experiences in analytical method development for different types of proteins, including but not limited to monoclonal antibodies, fusion proteins, antibody drug conjugates (ADCs), recombinant proteins and bispecific antibodies.
For the DS/DP release assays, we provide analytical method qualification/validation following ICH Guideline Q2(R1), FDA Guidance for Industry, PDA Technical Report No. 57, and USP General Chapter <1225>&<1226>. Assays to be qualified/validated include product-specific methods, process-related methods and microbiological methods.
We offer method transfer services to the receiving lab for analytical methods including but not limited to in-process testing assays, DS & DP release assays and characterization assays.
We offer method transfer services to the receiving lab for analytical methods including but not limited to in-process testing assays, DS and DP release assays and characterization assays.