ADC Services

ADCs (Antibody-drug conjugates) have emerged as a powerful therapeutic modality due to the ability to specifically target cancer cells while minimizing off-target toxicities. However, the development and manufacturing of ADCs comes with multiple challenges mostly due to their structural and molecular complexities, potential toxicities, and difficulties in matching the rapidly evolving technological landscape. CRO/CDMOs with specialized expertise and advanced infrastructure can address these issues and support the intricacies of ADC development. NJ Bio, Inc. offers comprehensive CRO/CDMO services at a single site for rapid development of ADCs. The proximity of multidisciplinary teams helps solve problems faster and more effectively, adding tremendous value to the entire drug development process.

ADC services encompass the complete range of processes and expertise required for the successful development of ADCs from antibody production and bioconjugation to method qualification and clinical manufacturing. At NJ Bio, we understand the challenges that arise in ADC development and have made strategic investments – both scientific and financial – to develop a robust platform that can be tailored to fit the unique requirements of each ADC program. Our expertise in both chemistry and bioconjugation allows us to optimize ADCs for specific biological targets and desired mechanisms of action. We have teams dedicated to each critical aspect of ADC development including – antibody production, bioconjugation, linker-payload synthesis, small molecule and payload chemistry, and analytical characterization. Our platform is designed to ensure seamless integration of these multidisciplinary processes, ensuring that our client’s ADC program progresses smoothly from discovery through clinical development. By leveraging our extensive experience and advanced technological platforms, NJ Bio offers innovative solutions and expert support at every stage.

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.

Bioconjugation

Our bioconjugation services are designed to produce ADC constructs with high-quality attributes. We offer a range of conjugation techniques, including amine (lysine-based) conjugation, thiol (cysteine-based) conjugation, site-specific conjugation, enzymatic conjugation, glycoconjugation, and click chemistry. Our bioconjugation experts leverage their expertise to design, optimize, and perform custom conjugations to meet specific project goals.

• 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/

Bioanalysis

Due to its complex nature, an ADC molecule requires precise analytical assessment to ensure its safety and efficacy. Our advanced analytical platform supports – DAR value determination, conjugation site confirmation, free linker-payload determination, residual unbound drug quantification, monomeric purity assessment, ADC serum stability assessment and cytotoxicity measurement.

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.

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

Functional Assays

Characterization of mAbs and ADCs present numerous challenges due to their structural complexity and heterogeneity. Thus, the use of precise and robust analytical techniques and assays is essential to study these molecules. We 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. Our advanced functional assay platform provides valuable biophysical and functional information of these complex molecules, enhancing drug development strategies.

For detailed information https://njbio.com/cell-based-functional-assay-including-cytotoxicity-assays/

Antibody Production

NJ Bio’s 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/

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 linkers, analytical support: method development & qualification, stability testing and release of clinical trial materials (CTM).

Small scale bioconjugation

We offer small-scale 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-services/

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-services/

Analytical Support: Method Development & Qualification

Analytical services involve rigorous testing, analysis, and interpretation of data related to drug substances and drug products. These services are aimed at ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. 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 re-testing 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 provided methods 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.