Our team of experts offer a comprehensive suite of immunogenicity testing services tailored to your specific clinical trial needs. Our expertise encompasses:
1. Phase I-III Trial Support:
- Design and implement immunogenicity assays customized to your drug candidate and clinical trial phase, ensuring reliable and relevant data collection.
- Conduct a wide range of assays, including anti-drug antibody (ADA) detection and characterization, cytokine analysis, and T-cell assays, to provide a comprehensive picture of the immune response.
- Employ state-of-the-art analytical techniques, including flow cytometry, ELISA, and multiplex assays (including MSD), for high sensitivity and specificity.
2. BSL-2 and BSL-3 Containment Capabilities:
- Conduct immunogenicity testing for both BSL-2 and BSL-3 agents in dedicated, high-containment laboratory facilities to ensure safe handling of potentially hazardous materials.
- Implement strict protocols and rigorous biosafety procedures to protect personnel and the environment.
- Maintain compliance with all relevant regulatory requirements and institutional biosafety guidelines.
3. Data Analysis and Interpretation:
- Employ sophisticated data analysis tools and statistical methods to interpret immunogenicity data accurately and identify potential safety signals.
- Provide detailed reports and expert interpretation of the results, outlining key findings and their implications for drug development and clinical trial design.
4. Regulatory Support and Documentation:
- Assist with regulatory submissions by providing comprehensive immunogenicity data packages that meet all regulatory requirements.
- Offer expert guidance on navigating regulatory expectations and ensuring compliance with ICH guidelines for immunogenicity testing.
5. Quality Control and Assurance:
- Implement rigorous quality control procedures throughout the entire testing process to ensure the accuracy, reliability, and integrity of data.
- Maintain GLP compliance and employ a dedicated quality assurance team to oversee all aspects of study conduct.