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Seamlessly Moving Your Program from Discovery to Regulated Preclinical Bioanalysis
As your drug development partner, our scientists provide you with the regulated preclinical bioanalytical support your compound needs for IND submission. Using the insights from our discovery efforts, we significantly reduce timelines by eliminating the need to transfer a compound from one unit to another. Our preclinical bioanalytical services support toxicology activities for small- and large-molecule drugs with global Good Laboratory Practice (GLP) regulatory compliance.
LC-MS/MS Quantitation of Peptides and Proteins
Rapid Method Development
- Peptides 2-4 weeks
- Proteins 4-6 weeks
- Non-specific binding
- Sensitivity tune-up
- Trypsin digestion conditions
- Microelution solid phase extraction (SPE) optimization
Diversified Peptides and Proteins
- Different species and matrices
- Molecule weight of surrogate peptide ~7000 Da
Fast Synthesis Capabilities
- 2 weeks turnaround time
- Synthesize surrogate peptide
- Synthesize SIL-IS
Using state-of-the-art equipment and advanced automation systems, our immunochemistry platform supports the development of large molecule products, including biologics, biomarkers and vaccines. Operating out of 20,000 square feet of GLP laboratory space, our Bioanalytical Services team has the capacity to handle over 60,000 samples per month, and has validated over 100 biomarker assays to support your large molecule programs.
Track Record of Experience
Immunogenicity Assessment Journey
Biotherapeutics present many challenges in drug development. One is that they are more likely to trigger the immune system when compared to small molecule drugs, which can lead to unwanted effects. Regulatory agencies require extensive immunogenicity testing, and neglecting this vital element of your Investigational New Drug (IND) package can lead to clinical delays. WuXi AppTec collaborates with you to develop custom reagents and assays that analyze key measures of the immune response, along with expert support in executing the multi-tiered testing that adheres to U.S. Food and Drug Administration (FDA) immunogenicity guidelines.
Custom Bioreagent Development
We develop custom reagents to support your candidate in the assessment of immunogenicity, PK and PD bioanalytical services. Once validated, they can rapidly analyze therapeutic candidates, to advance development efforts.
We can generate customized antibodies and proteins including:
- Recombinant proteins