Rapid Development of immunogenicity testing to detect Anti-Glargine antibodies with Successful Deployment to Phase III Trial
Our client, a global pharma, with footprints across Asia Pacific, Africa, Eurasia & Latin America, required a strategic partner with end-to-end capabilities in developing Ligand Binding Assay (LBA) and ADA assay to detect Anti-Glargine antibodies.
- Proven expertise and knowledge in developing and validating assays within set deadlines and high-quality benchmarks.
- Design assays that are precise, sensitive, and robust assays, adhering to global regulatory norms for identifying Anti-Glargine antibodies.
- Provide economical and efficient assistance that aligns with both time and financial limitations.
- Timely development and validation of the assay, aligning with stringent schedules. The tight timeline was crucial due to synchronized clinical development and imminent sample arrival (4-5 months).
Please complete the form to download the Case Study and learn how Navitas Life Sciences leveraged its LBA capabilities for stellar immunogenicity testing, developing a new immunogenicity assay for Anti Glargine antibodies, with study completion in just 4 weeks.
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