Our ADC Discovery Approach & Screening Platforms

ADC research and development services encompass a comprehensive array of specialized processes, from the initial design phase to product optimization and in-depth analytical testing. Our ADC discovery and research offerings include – bioconjugation, payload-linkers, bioanalysis, functional assays, and antibody-production.

We understand that no two ADC programs are the same. That is why we offer flexible and customizable services that can be adapted to the unique requirements of each client. During early proof-of-concept (PoC) studies, we help assess different payloads, linkers, and conjugation strategies to determine the most effective approach. Gram-scale conjugations are used to identify potential challenges, mitigate risks, and refine the process for scale-up. By combining our experience across a variety of targeting molecules, linkers, and payloads, we can design ADCs that deliver superior therapeutic profiles while being manufacturable at scale.

Many of our clients begin with only their monoclonal antibody (mAb) and we deliver a fully optimized ADC candidate specific to their intended therapeutic use. We specialize in addressing challenging chemistry problems, whether they involve hydrophobic payloads, unstable linkers, or aggregation-prone constructs. Our Antibody HT Bioconjugation Developability Screening Platform enables rapid evaluation of over 100 monoclonal antibodies (mAbs) at the same time to identify those best suited for ADC and bioconjugate development, accelerating the process of ADC development. With access to a broad spectrum of payloads and conjugation chemistries, including cleavable, non-cleavable, enzyme-sensitive, and novel linkers, we customize every solution to fit the unique needs of a project.

By integrating analytical and process development expertise into every step, we help clients move efficiently from discovery to CMC, ensuring a smooth path toward clinical development.

Our new linker-payload optimization platform is a key driver of our success. This platform was specifically created to overcome the limitations of the one-size-fits-all approach in ADC development. With access to over 2,000 diverse linker-payload combinations, this platform enables rapid screening of targeted libraries followed by in vitro and in vivo optimization, ensuring the rational design of candidates with the right balance of stability, efficacy, and pharmacokinetic properties.

We have used this optimization platform to develop next-generation ADCs overcoming a dose-limiting toxicity compared to their predecessors thus identifying best-in-class candidates. By combining advanced chemistry with high-throughput workflows, the platform accelerates the identification of lead candidates and expands therapeutic potential for our clients’ programs.

Bioconjugation

Our scientists are highly skilled in both traditional and advanced bioconjugation techniques. We routinely perform stochastic conjugation through lysine and cysteine residues, but we also bring extensive expertise in a wide range of site-specific methodologies. These include enzymatic conjugation, glycan remodeling, engineered cysteine approaches, click-chemistry, incorporation of non-natural amino acids, and the use of enzymatic tags.

Every conjugation process we design is built for robustness and scalability. We identify critical process parameters early, optimize purification strategies, and maximize yields while maintaining purity. This strong process foundation ensures that lead candidates can be advanced quickly and reliably into development and manufacturing.

We offer various bioconjugation models for clients to choose from based on the project requirements;

• Express Conjugation services are ideal for rapid assessment of ADC constructs. This service utilizes validated linker-payloads in combination with stochastic lysine- or cysteine-based conjugation and ensures quick turnaround times for time-sensitive projects.
• Standard Conjugation is preferred for larger scale monoclonal antibody (mAb) conjugation. This service provides access to a broader range of validated linker-payloads (e.g., DGN549, Tesirine, DM21C, or SPDB-DM4).
• Custom Conjugation is used to optimize the therapeutic index and is ideal for preclinical development and lead optimization. Payload-linkers and conjugation technologies can be optimized to obtain the most suitable candidate.

For detailed information https://njbio.com/bioconjugation-services/

Payload- Linkers

NJ Bio offers integrated chemistry services for the design and synthesis of linker – payloads. Our approach is focused on the mechanism of ADC activity, allowing us to deliver a wide range of services including synthesis of cleavable linkers (enzyme, lysosome, cathepsin, β-glucuronidase, esterase, phosphatase cleavage) and non-cleavable linkers, self-immolation tracer-free linkers, etc.

We supply validated as well as custom linker-payload combinations, to meet the clients’ unique project requirements. We can also support chemical scale-up and development of linker-payloads involving challenging chemistry. Based on client requirements, we optimize a wide range of cytotoxic payloads, including (but not limited to); auristatins (MMAE and MMAF), tubulysin, PBD Dimers, maytansinoids (DM-1, DM4), duocarmycin, camptothecins (exatecans, DXd, SN38), doxorubicin and immune-modulating agonists like (TLR, STING agonists)

We maintain a library of validated linker-payload combinations that enable us to assess bioconjugate performance based on efficacy, potency and other physicochemical properties. Years of experience in the field enables us to customize the most appropriate linker-payload for a given mAb using the latest technologies. This ensures they meet critical parameters like hydrophobicity, potency, solubility, activity and release kinetics.

Our synthetic chemists can also help design payloads that require unique chemistries and synthesize novel entities for accelerating ADC research. We optimize the stability, efficacy, and controlled release mechanisms of the payloads, which are critical for maximizing therapeutic windows and minimizing toxicity. Our ability to design, synthesize, and optimize both novel and validated linker-payload combinations adds significant value to our clients’ ADC development programs.

For detailed information https://njbio.com/payloads-linkers-antibody-drug-conjugates/

Antibody Production

Our custom antibody production services help in production of standard or engineered mAbs. Our platform integrates into larger bioconjugation projects offering a comprehensive solution for the synthesis of ADCs. We can use a client-provided antibody sequence or utilize our optimized constant region framework to produce a complete, functional antibody. Upon production the antibody undergoes rigorous validation using state-of-the-art analytical tools. We employ various cell-free assays such as BLI and ELISA to measure binding kinetics of antibody-antigen interactions, flow cytometry for interaction studies, IncuCyte® for internalization assessments, and plate-based IC50 analysis for cytotoxicity assays. Our robust processes and stream-lined approach allow us to produce antibodies with high specificity and affinity. Our rapid production times enable us to accelerate our clients’ ADC programs effectively.

For detailed information https://njbio.com/antibody-production/

Translational Research

Our translational research services provide specialized support to the development of ADCs, bridging the gap between pre-clinical discovery and clinical applications. We work with various xenograft and patient-derived models, immune-oncology platforms and humanized mouse systems to generate clinically relevant insights into ADC efficacy, safety and MoA. Our in vitro assays, PK/PD studies are tailored to evaluate payload activity, therapeutic window and various other parameters to help researchers make quick, data-driven decisions during the development process.

Our assay platform supports stage-appropriate in vitro screening and detailed evaluation of leads. NJ Bio specializes in bioanalytical services designed for early research. We have invested in acquiring state-of-the-art instruments to offer accurate and precise data to help our clients make informed research decisions. Based on the required data we use either Ligand Binding Assays (LBA), LC-MS and Hybrid capture LC-MS for analyzing diverse analytes. Each component of an ADC, that can affect the ADME properties and are critical for design and subsequent development of a clinically successful candidate are considered during the bioanalytical process.

We also offer a range of functional assays for ADCs that include ADC stability, receptor binding (EC50), PK analysis, stability assessment, target validation, and mode of action (MoA) studies – antibody internalization, bystander killing, apoptosis cell cycle assay. These assays provide reliable data to optimize therapeutic efficacy and understand the MoA of a candidate to ensure successful clinical outcomes.

Analytical Characterization

We offer specialized analytical characterization services for ADCs. Our capabilities cover comprehensive identity verification, detailed primary structure analysis, and assessment of purity, integrity, and impurities using advanced techniques such as LC-MS, CE, cIEF, HIC, and SEC-MALS. We also provide quantification and content determination, along with critical safety testing including bioburden, endotoxin, and heavy metal analysis. Leveraging a robust analytical platform and a wide array of in-house tools for large molecule studies, we deliver high-quality, reliable data to support early-stage ADC development.

For detailed information https://njbio.com/analytical-services-for-adcs-small-molecules-large-molecules/

Bioanalytical Testing

NJ Bio offers comprehensive bioanalytical services to accelerate bioconjugation and drug discovery programs, leveraging state-of-the-art LC-MS technologies and advanced instrumentation for high sensitivity and resolution. Our deep expertise in chemistry and bioconjugation ensures precise and accurate characterization of diverse biological molecules. From in vitro metabolic stability assays, rapid PK analysis, and quantitative tissue distribution studies to DAR value determination, conjugation site confirmation, monomeric purity assessment, residual unbound drug quantification, and cytotoxicity measurement, NJ Bio delivers reliable data to support every stage of development.

For detailed information https://njbio.com/bioanalytical-services-for-adcs-and-other-bioconjugates/

GMP Manufacturing – Phase I & II

ADC manufacturing is a complex, multi-step process that involves the precise conjugation of GMP-grade antibodies to GMP payload-linkers, followed by rigorous purification and testing to ensure product quality before final formulation and fill-finish. Our comprehensive ADC manufacturing services include small-scale bioconjugation, GMP payload linker synthesis, analytical support: method development & qualification, stability testing and release of clinical trial materials (CTM) for early phase clinical studies.

Process Development & Scale-up

At NJ Bio, we specialize in process development and scale-up for linker-payloads, tackling the unique challenges of complex chemistry with precision and efficiency. Our team leverages deep expertise in synthetic chemistry, analytical characterization, and manufacturing optimization to design robust, reproducible processes for complex linker-payload constructs. From early-stage feasibility studies to clinical production, we address challenges such as stability, solubility, and controlled reactivity, delivering optimized solutions that accelerate your drug development pipeline. By combining innovative chemistry with scalable manufacturing strategies, we help partners reliably translate lab-scale discoveries into high-quality material for preclinical and clinical applications.

GMP Bioconjugation

We offer small-scale GMP bioconjugation services to support ADC programs for preclinical research to early-stage clinical production. Having both our research and manufacturing facilities at the same place facilitates a smooth transition and method transfer, accelerating clinical development. Levering our expertise in using advanced bioconjugation technologies, we carry-out efficient linkage of cytotoxic payloads and mAbs, optimizing their therapeutic potential for clinical use.

For detailed information https://njbio.com/manufacturing-and-cdmo-services/#bioconjugation-cdmo

GMP Payload-Linkers

NJ Bio’s GMP compliant payload-linker manufacturing is carried out in the newly inaugurated ‘Small Molecules Chemistry Suite’, designed specifically for the synthesis of highly potent and cytotoxic payloads. This suite is well equipped with advanced technologies for chemical payload-linker development and synthesis. Our high potency lab is designed to handle derivatives or analogs of highly potent cytotoxic agents, whether of natural or of synthetic origin, such as auristatin, maytansinoids, duocarmycins, and more. Our extensive capabilities include process development and optimization, bioconjugation, novel linker-payload technology and production of ADC drug substance (DS).

A state-of-the-art facility, strong experience in early research and development, and extensive knowledge of novel linkers, payloads, and conjugation technologies, enables us to streamline the drug development pipeline, ensuring a smooth transition from discovery to clinical material production of novel therapeutics.

For detailed information https://njbio.com/manufacturing-and-cdmo-services/#payload-linker-manufacturing

Analytical Characterization: Method Development & Qualification

We provide comprehensive analytical services to support every stage of ADC development, from raw material testing to release and stability studies. Our diverse analytical platform allows us to characterize each conjugate thoroughly, providing insights into potency, stability, and safety that are critical for both development and regulatory approval. NJ Bio Analytics addresses challenges related to product quality, scalability, safety and cost at each stage of its development. Our state-of-the-art analytical laboratory and industry leading analysts guide our clients’ product development decisions. With our experienced team and high-end laboratory, we can address the most intractable characterization challenges brought to us in-house, providing the production teams clarity and the way forward. We carry out analytical characterization of the primary structure, purity, integrity, impurity, content and safety using various assays such as peptide mapping, siteDAR analysis and advanced chromatographic techniques (RP-HPLC, HIC, LC-MS).

For detailed information https://njbio.com/purification-and-analytical-services/

Stability & Release Testing

NJ Bio offers clinical trial material stability and release testing that assesses the drug substance or in-process material consistently. Our stability studies assess parameters like potency, impurity profiles, physical properties and safety under cGMP compliance. We also provide tailored testing to ensure product safety and efficacy over time, with regular retesting based on regulatory standards. Stability testing at various key stages during the manufacture process ensures the developability of the product. Our team can carry out the studies based on methods provided by the clients or methods developed and validated by us. Our entire manufacturing process and final product shipping is carried out in adherence to regulatory standards.

Why Partner with NJ Bio?

At NJ Bio, ADC development is more than a service—it is our specialty. With years of dedicated experience, an industry-leading linker-payload platform, and a fully integrated workflow that spans discovery through GMP readiness, we are uniquely positioned to accelerate your program. Whether you are seeking to develop a novel therapeutic or optimize an existing ADC, our team brings the expertise, flexibility, and innovation needed to deliver best-in-class solutions.

By working with NJ Bio, you gain a partner committed to creating ADCs that combine efficacy with safety, speed with reliability, and innovation with manufacturability.