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High-Throughput Screening
(HT Bioconjugation)
Integrated High-Throughput Bioconjugation & Screening Platform
High-throughput bioconjugation and bioassay services are critical to the timely development and evaluation of antibody-drug conjugates (ADCs) and other complex bioconjugates. High-throughput screening (HTS) requires specialized equipment and expertise that only a reliable partner can perform. Specialized CROs partners support client bioconjugate programs from concept to candidate selection, helping accelerate projects, reduce development costs, and decrease time-to-market.
As a specialized CRO/ CDMO, NJ Bio provides an integrated high-throughput (HT) bioconjugation and screening platform that is designed to streamline and expedite ADC development. This platform is designed to assist with antibody selection and lead discovery of the linker-payload. Our integrated drug development platform allows us to combine advanced bioconjugation technology, analytical characterization, and biological screening at a single site. To accommodate diverse client requirements, we leverage a range of advanced analytical instrumentation and technologies. With deep expertise in assay development, our team of scientists enables us to offer high-quality, data-driven results that can help clients make informed research decisions.
EFFICIENCY
Rapid screening of large library of antibodies for ADC candidates, accelerating the discovery and development process.
PAYLOAD OPTIMIZATION
Evaluate a range of the cytotoxic payloads for ADC candidates and check their potency.
TARGET SPECIFICITY
Platform can be extended to check binding specificity for a range of payload-linker combination minimizing off-target effects and reducing harm to healthy tissues.
PLATFORM CUSTOMIZATION
The platform could be adapted to screen different mabs with one PL, one mAb with various PLs or even one mAb with one PL different conditions, e.g. DAR, buffer, etc.
Antibody HT Bioconjugation Developability Screening Platform
A key component of this platform is our Antibody HT Bioconjugation Developability Screening, which enables rapid evaluation of over 100 monoclonal antibodies (mAbs) at the same time to identify those best suited for ADC and bioconjugate development. The process begins with an initial screening to eliminate antibodies with poor stability, poor properties or weak antigen binding. Selected mAbs then undergo serum and thermal stability assessments to identify those capable of withstanding physiological and manufacturing conditions. Stable candidates are advanced to conjugation evaluation, where the most suitable conjugation method is identified. Multiple linker-payload combinations are screened to assess conjugation efficiency, drug-to-antibody ratio (DAR), and aggregation levels. Detailed profiling of reducibility, thiol accessibility, and aggregation behavior is conducted, and highly aggregated or poorly conjugating antibodies are excluded from further development. Purified conjugates are further screened by in vitro cytotoxicity and binding studies to confirm biological activity and target specificity. The top candidates are selected for further optimization, including refinement of conjugation chemistry and payload selection.
NJ Bio’s HTS Capabilities
An entry point for the HTS capabilities is to evaluate a diverse panel of monoclonal antibodies to identify candidates with optimal conjugation compatibility. Our high-throughput antibody screening platform rapidly assesses critical parameters such as site accessibility, conjugation efficiency, aggregation and stability post-conjugation, impact on antigen-binding post-modification, etc. This allows for early de-risking and faster selection of lead antibody candidates suitable for conjugation.
We generate a matrix of antibody-payload combinations with varying DAR (drug-to-antibody ratios) based on our in-house conjugation workflows and parallel synthesis capabilities. This platform allows rapid and reproducible generation of complex conjugates with defined DAR profiles, evaluation of linker-payload chemistries, and assessment of the relationship between DAR and functional performance. Analytical tools such as LC-MS, HIC, and RP-HPLC are integrated into the platform to ensure precise DAR quantitation and conjugate integrity.
To link structure with function, ADCs can also be screened through in vitro bioassays in the same workflow. We offer cytotoxicity profiling, binding (BLI), and internalization studies. These assays enable rapid ranking of conjugate candidates based on potency, specificity, and developability, enabling clients to make informed decisions.
Case study: Payload Screening Using Herceptin
The experiment was conducted in triplicate for four different antibodies, each conjugated with Vedotin (MMAE) as the linker-payload candidate. A consistent drug-to-antibody ratio (DAR) trend was observed, in agreement with previous findings. Specifically, DAR increased linearly with the PL:NEM ratio, demonstrating the high reproducibility of the high-throughput (HT) conjugation platform within the tested range. Based on these results, DAR values of 4.2 ± 0.20 and 2.60 ± 0.10 can be predicted with 95% confidence.
Why NJ Bio?
Speed & Scalability
Rapid parallel processing shortens lead identification timelines
Data Integration
Conjugation, DAR profiling, and biological data are unified into a single decision framework
Customization
Platform can be adapted for ADCs, AOCs, PDCs, and novel bioconjugates
Integrated support
Bioassay services, in vivo characterization etc., all within one integrated CRO/CDMO service
Maximize data from limited mAbs
If mAbs are limited, a larger screen of linker–payload combinations can be performed to maximize data output and identify optimal conjugates.
Comprehensive Testing Technologies
Equipped with multiple mass spectrometers and screening systems. Comprehensive research and analysis platform
Key Instrumentation
Frequently Asked Questions (FAQs)
What is the operational scale of the high-throughput conjugation platform?
The high-throughput conjugation platform can be used for screening and early development work. can be used for small-scale conjugations, ranging from 100 µg to 1 mg of antibody.
What is the average yield of the conjugation process?
Depending on the specific antibody and conjugation conditions, the average yield is approximately 50–60%.
Can the HT platform be used for site-specific monoclonal antibodies?
Yes, the platform can be used for site-specific monoclonal antibodies. However, it must be noted that omitting reducing agents such as TCEP may lead to lower conjugation yields.
Are conjugated antibodies suitable for downstream assays such as cytotoxicity or binding?
Yes, the conjugates generated using this platform are compatible with downstream applications including cytotoxicity assays, binding studies, and other functional evaluations.
How is residual free payload (PL) removed from the final product?
Samples are purified twice using spin columns or plates to remove excess free PL. Residual PL is then assessed using mass spectrometry (MS). The limit of detection (LOD) for this assay is being confirmed to ensure stringent quality control.