Large Molecule Bioanalysis
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Advancing your Biotherapies to Market
WuXi AppTec offers comprehensive capabilities and sophisticated technology platform in the global pharmaceutical industry. You’ll work with a team of experts who are at the forefront of analytical testing for the next generation of biotherapeutics – and dedicated to clearing a path to more efficiently advance your biotherapies to market.
WuXi AppTec’s bioanalytical team has the experience and expertise to help you move your drug candidate to the next milestone. We’ll customize a program that meets the evolving needs of your project, from study design to regulatory submission.
Download our Large Molecule Bioanalysis Brochure
Your ability to make intelligent, informed decisions hinges on having the right bioanalytical strategy. We can help you develop an approach that will take you from discovery through preclinical to IND and beyond – with leading efficiency and speed.
Industry-Leading Services for Your Drug Development Journey
Track Record of Experience
Supporting You from Preclinical through New Drug Application
- Pharmacokinetics (PK) Bioanalytical Services
- Toxicokinetics (TK) Bioanalytical Services
- Immunogenicity ADA and Neutralizing Antibody (NAb) Service
- Statistical analysis of Cut-Point and Low Positive Control determination
- Exploratory and decision-making biomarker screening/discovery: Ligand Binding Assay (LBA) and LC-MS/MS Services
- Monoclonal and Polyclonal Reagent Generation
Immunogenicity Bioanalytical Services (GLP)
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.
Screening, Confirmatory and Titer Determination Process
Screening, Confirmatory and Titer Determination Process
- Reagent generation to fit biological therapeutic using monoclonal or polyclonal antibodies for positive controls and epitope-specific reagent purification
- Anti-drug antibody (ADA) electrochemiluminescent (ECL) bridging assays with capabilities of executing complex assays for difficult biotherapeutics
- Statistical analysis of cut-point and low positive controls in U.S. FDA-acceptable report format
- Non-cell-based neutralizing antibody (NAb) assays
- High drug tolerance with bead extraction and acid dissociation (BEAD)
- Cell-based neutralizing antibody assays
Navigating the Immunogenicity Assessment
Large Molecule FAQs
What is large molecule bioanalysis?
Quantitative analysis of large molecules involves measuring biological drugs, including proteins, peptides, and monoclonal antibodies, in different biological samples. This method is crucial for assessing the pharmacokinetics, effectiveness and safety of large molecule treatments.
Why is bioanalytical testing important for large molecules?
Testing large molecules through bioanalysis is crucial because of their intricate structures and distinctive pharmacokinetic characteristics. Precise measurement is essential for scientists to understand their absorption, distribution, metabolism, and excretion, which is vital for optimizing dosage and conducting safety assessments.
What types of samples are analyzed in large molecule bioanalysis?
Large molecule samples usually consist of blood, plasma, serum, urine, tissue and other biological fluids. They are examined to measure the levels of medications and their byproducts.
What analytical techniques are used for large molecule bioanalysis?
Commonly employed techniques for large molecule bioanalysis include ligand-binding assays (LBAs) like enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence (ECL) and surface plasmon resonance (SPR). In addition, mass spectrometry-based methods (e.g., LC-MS/MS) are utilized for comprehensive analysis.
How are bioanalytical methods validated for large molecules?
Bioanalytical techniques for large molecules undergo validation in compliance with regulatory standards to guarantee accuracy, precision, sensitivity, specificity and reproducibility. Validation serves to verify that the techniques yield dependable and uniform results.
What regulatory guidelines govern large molecule bioanalysis?
Bioanalysis of large molecules must adhere to regulatory guidelines set forth by international regulatory bodies. These guidelines delineate the criteria for validating methods, analyzing samples, and reporting data.
Can customized bioanalytical services be provided for large molecule projects?
Yes, bioanalytical services can be customized to cater to the specific requirements of various large molecule projects. This encompasses developing and validating distinctive analytical methods to tackle particular research inquiries.
What are the challenges in large molecule bioanalysis?
Challenges arise from large molecules’ intricate structure and size, their potential immunogenicity, and the requirement for highly sensitive and specific analytical methods. Overcoming these challenges is made possible with advanced techniques and the expertise of experienced scientists.
How long does it typically take to complete a large molecule bioanalysis study?
The timeframe for a large molecule bioanalysis study is contingent upon the project’s complexity, the quantity of samples, and the analytical methods needed. Typically, timelines are deliberated and finalized during the project planning phase.
What types of large molecule bioanalytical services does WuXi AppTec provide?
WuXi AppTec offers a range of large molecule bioanalytical services, including pharmacokinetics (PK), toxicokinetics (TK), immunogenicity testing, and biomarker discovery. These services support drug development from discovery to regulatory submissions, including extensive experience with new modalities.
What technologies are employed in large molecule bioanalysis at WuXi AppTec?
The lab utilizes advanced technologies such as Ligand Binding Assays (LBA), LC-MS/MS, and cell-based assays to ensure precise and reliable results.
Can WuXi AppTec customize bioanalytical studies for specific project needs?
Yes, WuXi AppTec tailors its bioanalytical programs to meet the evolving needs of each project, ensuring efficient and practical advancement of drug candidates.
How does WuXi AppTec handle immunogenicity assessments for large molecules?
The company provides comprehensive immunogenicity testing, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, adhering to U.S. regulatory guidelines.
What support does WuXi AppTec offer for regulatory submissions involving large molecules?
WuXi AppTec supports all stages of regulatory submission, providing expert guidance and customized testing to meet stringent regulatory standards.
Where are WuXi AppTec’s bioanalytical labs located?
We have leading integrated laboratory operations in New Jersey and China, including Central Laboratory Services.