How AntibodyLLM saved a critical IVD product launch by expressing a challenging antibody that multiple CROs had deemed impossible, achieving 2.8 g/L yield in 16 weeks.
Our client is a leading in vitro diagnostic (IVD) company specializing in high-performance immunoassays for clinical diagnostics. They had developed a breakthrough diagnostic test targeting a novel biomarker for early cancer detection.
The success of their diagnostic test depended on a critical antibody with unique binding properties. This antibody had been extensively validated for specificity and sensitivity, making it essential for the test's performance. However, the antibody was extremely difficult to express at commercially viable yields.
With the product launch deadline approaching, the client was in crisis mode. Multiple contract research organizations (CROs) had attempted to express the antibody, with all concluding it was "impossible to express" at commercially viable levels. The company faced the devastating prospect of canceling a product that could revolutionize early cancer diagnosis.
We conducted a comprehensive analysis using our AntibodyLLM platform, examining the antibody's sequence, predicted structure, and expression characteristics. Our AI model identified subtle issues in the antibody's framework regions that were causing misfolding and degradation.
The analysis revealed that the antibody had optimal binding properties but suboptimal expression characteristics—a classic case of structure-function tradeoff that traditional approaches couldn't resolve.
Our AI model proposed a series of targeted modifications designed to improve expression while preserving the antigen-binding CDR regions. We focused on framework optimizations that would enhance protein folding and secretion without affecting the antibody's binding affinity.
The optimization strategy was highly conservative, making only changes with predicted high confidence for expression improvement and minimal risk to function.
Given the tight timeline, we implemented a parallel development approach, simultaneously testing multiple optimized variants. Our high-throughput screening platform rapidly identified the best-performing candidates.
The lead candidate demonstrated excellent expression characteristics while maintaining all critical binding properties, enabling us to rapidly advance to stable cell line development and GMP production.
"AntibodyLLM literally saved our product launch. After four different CROs told us this antibody was impossible to express at commercially viable levels, we were facing the cancellation of a flagship diagnostic product. AntibodyLLM's AI approach solved what others couldn't, delivering high-quality antibody on our timeline. Their team's expertise and dedication were exceptional. We've since made them our preferred antibody development partner."
CHO-K1 stable cell line
Fed-batch bioreactor
<0.1 g/L (4 CROs failed)
2.8 g/L (AntibodyLLM)
16 weeks
Preserved at target Kd
Our AI platform can solve antibody expression challenges that traditional approaches can't.