Integrated CRDMO Services for ADCs
Overview
At the intersection of complex chemistry and precision biology, Cohance Lifesciences and NJ Bio offer integrated CRDMO (Contract Research, Development, and Manufacturing Organization) services tailored for Antibody-Drug Conjugates (ADCs). From linker-payload synthesis to bioconjugation and clinical-scale GMP production, we support your ADC programs across all development stages and follow-up studies with seamless execution and quality-focused approach.
Our integrated CRDMO model is designed for agility, scale, and regulatory readiness—helping biopharma innovators bring safer, more effective ADCs to market, faster.
Why Cohance + NJ Bio for Integrated CRDMO Services?
Why Cohance + NJ Bio for Integrated CRDMO Services?
- Deep expertise in ADC domain, with integrated knowledge spanning chemistry, biology, and manufacturing
- Purpose-built facilities for bioconjugation and HPAPI containment
- Market leaders in S-Trione production, the key intermediate for camptothecin-based payloads
- Operational stability and de-risked supply chain
- Agile and collaborative CRDMO partnership with regulatory foresight
Manufacturing Strengths
Manufacturing Strengths
Scalable Production: Flexible volumes from gram to multi-ton capacity across multiple sites.
GMP-Ready Infrastructure: USFDA-, EMA-, and PMDA-approved sites with validated processes and full traceability.
Technology-Enabled Execution: Flow reactors, high-pressure systems (up to 20 kg/cm²), cryogenic capabilities (-70°C), and automation.
Regulatory Compliance: 200+ DMFs filed globally; extensive experience in audits and global market readiness.
Lifecycle Manufacturing: Support for reprocessing, impurity purge, solvent recovery, and green manufacturing practices.
Core Capabilities
Scalable
Production
Flexible volumes from gram to multi-ton capacity across multiple sites.
GMP-Ready
Infrastructure
USFDA-, EMA-, and PMDA-approved sites with validated processes and full traceability.
Technology-Enabled
Execution
Flow reactors, high-pressure systems (up to 20 kg/cm²), cryogenic capabilities (-70°C), and automation.
Regulatory
Compliance
200+ DMFs filed globally; extensive experience in audits and global market readiness.
Lifecycle
Manufacturing
Support for reprocessing, impurity purge, solvent recovery, and green manufacturing practices.
Innovative
Bioconjugation Platforms
Expertise in both site-specific and conventional/stochastic conjugation with process optimization to ensure consistency, stability and clinical readiness for ADCs.
In-house
Synthesis
Reliable production of chemical building blocks and complex intermediates, reducing dependency on external suppliers, ensuring supply chain stability and optimizing both cost & timelines of the project.
Unique Chemistry
Solutions
We recognize that every molecule presents distinct challenges, and we customize our chemistry strategies to align with each program’s goals and target biology.
Customized & Scalable
Linker-Payload Synthesis
Tailored synthesis with process optimization to ensure efficiency, reproducibility and scalability.
Scalable GMP
Manufacturing
Phase-appropriate production in state-of-the-art facilities with global regulatory compliance.
Analytical &
Regulatory Support
CMC development, complete characterization& qualified methods, submission-ready documentation.
Problem-solving
Expertise
Proven capabilities in complex chemistry allows for effective resolution of inherent challenges in ADC development.
Facilities
Genome Valley R&D Center: 25,000 sq. ft. of dedicated process development and safety labs.
Commercial Manufacturing Sites: Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.
Flow Chemistry Suites: Plug flow reactors, Corning G1 systems, and photo flow platforms.
Comprehensive Services
Discovery to IND Support
Early discovery, rapid proof-of-concept (PoC), synthesis of linker-payload variants, conjugation feasibility, and lead candidate selection.
Integrated Analytics
Comprehensive characterization approach combining bioanalytical assays (LC-MS, ELISA, hybrid assays); functional assays (cytotoxicity, receptor binding, antibody internalization); and advanced BioNMR for structural evaluation.
Process Development
Route scouting, impurity profiling, DoE optimization, and tech transfer.
Bioconjugate Development
Selection of optimal bioconjugation strategies for enhanced stability and targeting.
GMP Manufacturing
Clinical supply of ADCs and intermediates for Phase 1 & 2 trials, with scalable linker-payload production capabilities to support commercial manufacturing.
Genome Valley R&D Center
25,000 sq. ft. of dedicated process development and safety labs.
Commercial Manufacturing Sites
Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.
Flow Chemistry Suites
Plug flow reactors, Corning G1 systems, and photo flow platforms.
Facilities
We operate a robust network of cutting-edge small molecule development and manufacturing facilities across India. Our infrastructure spans lab-scale discovery to large-scale commercial manufacturing — enabling faster, flexible, and scalable solutions for your drug development needs.
Genome Valley R&D Center
25,000 sq. ft. of dedicated process development and safety labs.
Commercial Manufacturing Sites
Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.
Flow Chemistry Suites
Plug flow reactors, Corning G1 systems, and photo flow platforms.
Our early-stage R&D and kilo labs are designed to support route scouting, process development, and scale-up studies.
NJ Bio, Princeton
New Jersey, US
Designed to seamlessly scale from clinical to commercial manufacturing, these facilities are compliant with global regulatory standards including the US FDA.
Genome Valley R&D Center
25,000 sq. ft. of dedicated process development and safety labs.
Commercial Manufacturing Sites
Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.
Flow Chemistry Suites
Plug flow reactors, Corning G1 systems, and photo flow platforms.
From grams to tons-trust Cohance to deliver your small molecule at scale.
Contact Manufacturing Team
Launch your next ADC program with a partner who understands the scientific complexity, chemical precision and operational speed it takes.
Contact UsResources
- Webinar: Mastering Payload-Linker Chemistry for ADC Success
- Case Study: Seamless Tech Transfer for a Phase 1 ADC Program
- Whitepaper: Integrated CRDMO Models for Complex Bioconjugates
- Blog: How Site-Specific Conjugation Enhances ADC Potency and Safety
Resource Highlights
Webinars
Navigating Regulatory Audits in Small Molecule Manufacturing
Whitepapers
Smart Scale-Up Using Flow Chemistry
Case Studies
Seamless Tech Transfer of a Multi-Step Synthesis
Blog
Building Sustainable API Supply Chains
Webinars
Navigating Regulatory Audits in Small Molecule Manufacturing
Whitepapers
Smart Scale-Up Using Flow Chemistry
Case Studies
Seamless Tech Transfer of a Multi-Step Synthesis
Blog
Building Sustainable API Supply Chains
Our Global Accreditations
At Cohance Lifesciences, every facility stands as a testament to our commitment to uncompromised quality. Below is a snapshot of regulatory approvals and certifications across our global network
API Manufacturing Facilities
API Unit I
• US FDA, EU, PMDA, Russia MOH, KFDA, COFEPRIS, CDSCO, DCA, WHO GMP
API Unit II
• EU, DCA
API Unit III
• US FDA, EDQM, PMDA, KFDA, ANVISA, COFEPRIS, CDSCO, DCA
API Unit IV
• US FDA, EU, CDSCO, DCA
API Unit V
• ISO, DCA
Formulation (FDF) Facilities
FDF Unit I
• US FDA, Health Canada, MHRA, ANVISA, COFEPRIS, Russia MOH, TGA, Philippines FDA, Tanzania FDA, Greece NOM, Uganda NDA, Germany, SFDA, CDSCO, DCA
FDF Unit II
• CDSCO, DCA
Clinical Research
CR Bio
• US FDA, DCGI, MOH Turkey, BPFK Malaysia, WHO Geneva, MHRA, GCC, NPRA Malaysia
Suven Pharma Sites
Unit 1 to Unit 4, and Unit 6
• British Safety Council, International Safety
• ISO 20400:2017, ISO 22301:2019, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 50001:2018
Unit 5
• US FDA, DCA, PPD Global Quality Compliance, EU, CDSCO
• ISO 22301:2019, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 50001:2018
Casper
• US FDA, DCA
Our ESG Aspirations
Cohance is committed to a sustainable future with ambitious goals:
- Net-Zero Emissions by 2050: Focusing on decarbonization, renewable energy, and resource efficiency, aligned with Science-Based Targets (SBTi).
- Environmental Sustainability: Enhancing green practices through sustainable procurement and biodiversity protection.
- Social Impact: Expanding community engagement in health, sanitation, and water access, while supporting economic development through CSR initiatives.
- UN SDG Alignment: Contributing to goals like Good Health and Well-Being, Clean Water and Sanitation, and Responsible Consumption and Production.
- Ethical Governance: Strengthening transparency, ethics, and responsible sourcing through global initiatives like the Pharmaceutical Supply Chain Initiative (PSCI).
At Cohance, ESG is our promise to go above and beyond, shaping a sustainable future for health science through passion, expertise, and unwavering responsibility.
History
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We’ll help you test bold new ideas while sharing your.
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