ADC manufacturing is a complex process requiring seamless integration of chemical and biological entities. Variability issues may arise at various stages impacting conjugation efficiency, stability, and post-production modifications. External partners that offer end-to-end services are equipped to handle unexpected challenges, ensuring continuity in the supply chain and effectively addressing risks during the development and manufacturing process. Thus, partnering with the right CRDMO and investing in suitable technological platforms can help accelerate an ADC program while increasing chances of clinical success.

As a trusted CRDMO, NJ Bio is proud to expand its service offerings to include large-scale ADC payload manufacturing and commercialization through a strategic partnership with Suven Pharma. This collaboration combines NJ Bio’s award-winning CRO expertise with Suven’s 30+ years of CDMO experience in APIs, to provide end-to-end services from development to clinical supply and commercial manufacturing, with a specific focus on payload-linker (ADC construct) production.

With deep expertise in synthetic chemistry and manufacturing, our teams are committed to drive successful outcomes for biopharma companies working on next-generation ADC development. NJ Bio specializes in linker-payload innovation & optimization and through this collaboration, our clients can gain access to one of the largest commercial supplies of s-trione, exatecan, SN-38 and various other camptothecin (CPT) derviatives. This reinforces our vision of offering customized linker-payload solutions tailored to our clients’ specific targets.

Our integrated, one-stop-shop model is built on strong scientific foundations, expert teams, and a proven ability to troubleshoot complex chemistry challenges from concept to commercialization. By continuously investing in new technologies and adapting to evolving client needs, we provide a full range of flexible solutions for ADCs that aim to enhance efficiency, innovation, and clinical outcomes.

Choosing Camptothecin Derivatives as Payloads

Camptothecin derivatives are known to significantly enhance the therapeutic index. Suven’s proprietary “synthetic route” technology allows to modify the camptothecin core through the S-Trione intermediate, enabling large scale synthesis of different derivatives. Their fully backward integrated manufacturing process ensures complete control over production. Under the collaboration, we can offer access to over 2,000 CPT derivatives to support ADC development. Our joint expertise in CPT-based linker-payload technology ensures we can effectively address the complexities of ADC development and significantly reduce the time-to-market, while maintaining the highest standards of quality. All potential impurities are identified and controlled using a Quality by Design (QbD) approach with rigorous specifications aligned with ICH small molecule acceptance criteria. This ensures consistency, safety, and regulatory compliance throughout the development and manufacturing process.

Fully Integrated Global ADC Platform

NJ Bio is a pioneer in delivering customer-centric ADC solutions and offering comprehensive support from discovery and proof-of-concept (PoC) to early-stage manufacturing. With years of experience as an ADC CRO we have worked with 150+ companies globally to provide integrated services for discovery, development and optimization of ADCs. Our state-of-the-art facility in Princeton, NJ, backed by a highly experienced team enables us to deliver chemistry-based solutions to complex ADC problems encountered throughout the development lifecycle. Suven and NJ Bio have partnered to provide ADC services that encompass expertise and technical capabilities required to advance ADC development from preclinical payload synthesis and bioconjugation to clinical and commercial manufacturing of payloads. We can now offer comprehensive CDMO services right up to commercialization, specializing in customized CPT-based payloads and intermediates.

With a global footprint, including manufacturing facilities in India and the U.S., we serve clients worldwide. Our facilities include well-equipped R&D labs, pilot plants and large-scale manufacturing units, GMP-certified and U.S. FDA-approved facilities (Hyderabad, India) all designed with comprehensive safety measures for handling HPAPIs. Our strong R&D expertise enables process development, optimization and material supply across the entire product lifecycle.

NJ Bio’s deep expertise in ADC and broader XDC development, combined with Suven’s backward integration in camptothecin-based payloads, creates a powerful ADC/ XDC platform offering cutting-edge solutions across the ADC value chain.

Supporting services

We are equipped with state-of-the-art analytical platform to ensure the purity, stability and quality of ADC products. Our sites provide full process and analytical development services, supporting proof-of-concept and toxicology studies while ensuring a smooth transition to commercial manufacturing of ADC payloads.

We can offer:

• LC/ MS/ HPLC/ IEX, cIEF, UV/Vis, and various other physical and chemical studies for advanced ADC characterization
• Process development services to optimize conjugation strategies, formulation, purification and scale-up

How this Partnership Benefits our Clients

• Phase-adapted, scientifically driven development across the drug lifecycle
• Cross-functional collaboration between ADC experts accelerating innovation
• Robust processes and advanced analytics for complex molecules
• Integrated systems with established tools and procedures for streamlined workflows
• High-containment facilities designed for handling high-potency APIs (HPAPIs)
• Accelerated timelines with synchronized development strategies
• Stable and secure supply chain management for uninterrupted project execution
• Commercial and customized linker options tailored to unique ADC programs
• GMP-certified cytotoxic manufacturing facilities, equipped to produce batches from 500g to multi-kg scale.
• Customized development and manufacturing of campthothecin-based payloads to meet specific program needs.