- About Us
- Services & Solutions
- WuXi XDC – Bioconjugation
- News & Media
Offering End-to-End Solutions
Analytical ServicesThe Analytical Sciences (AS) department provides a broad range of analytical services for biologics development including:
In addition, AS helps 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:
Biologics Analytical Techniques
|UV280 Protein Content|
|General: Appearance, Color, Clarity, pH, Osmolality
Particles: Visible Particles, Subvisible Particulate Matter
Biosafety: Sterility, Bioburden, Endotoxin
|Impurities: HCP, Residual Protein A, Residual DNA|
Fragment: Reduced/Non-Reduced CE-SDS
Charge Variants: cIEF, AEX, CEX
|CD, FTIR, DSC, SEC-MALS, AUC|
|ELISA or Cell-Based Antigen-Binding (ELISA, SPR, FACS, ECL etc.)
Fab/Fc Function (ADCC, CDC, FcγR/ FcRn)
We follow appropriate testing procedures that comply with CP, USP and/or EP for each integrated project depending on its filing region.
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.