- 24 Tech Roqad st Ny 10023
- editech@mail.com
NJ Bio, a Cohance Lifesciences company, is a global leader in the development and supply of high-potency payloads and linkers for Antibody-Drug Conjugates (ADCs). We specialize in Camptothecin (CPT) derivatives and proprietary S-Trione scaffolds—designed for high cytotoxicity, optimal conjugation, and scalable synthesis.
Our payload supply solutions span R&D through GMP commercial production—meeting the highest standards of quality, containment, and regulatory compliance.
CPT Derivatives Mastery: Expertise in Exatecan Mesylate, SN-38, Irinotecan, and Topotecan derivatives.
Proprietary S-Trione Platform: Novel payloads with enhanced stability and therapeutic index.
GMP Manufacturing: Fully synthetic routes enabling multi-kg batch production under strict containment.
Regulatory Ready: DMF filings for key payloads including Exatecan and MMAE (expected Oct–Nov 2025).
Custom Payload Synthesis: Tailored derivatives based on cytotoxicity profile and linker compatibility.
Linker Development: Maleimide, hydrazone, and proprietary cleavable/non-cleavable linkers.
Process Optimization: Scalability assessments and impurity fate studies.
Containment Excellence: Handling of compounds with OEL < 20 ng/m³ in both R&D and GMP environments.
GMP Multi-Kilo Facility: Equipped with glass-lined, SS, and Hastelloy reactors up to 1,500 L.
Advanced Drying & Milling: Jet mills, vacuum dryers, ANFDs for precise powder handling.
Isolator Suites: For kilo-scale payload synthesis with dedicated containment zones.
Specialized in high-potency payloads for ADC applications
Proprietary platforms and scalable synthetic methodologies
Strong backward integration and supply reliability
Regulatory track record and global compliance
Webinar: Scaling High-Potency Payloads for Clinical and Commercial Supply
Whitepaper: Innovations in Camptothecin-Based Payload Synthesis
Case Study: Multi-Kilo Production of Exatecan Under Containment
Blog: What Makes a Reliable Payload Partner in the ADC Ecosystem?
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 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
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
CR Bio
• US FDA, DCGI, MOH Turkey, BPFK Malaysia, WHO Geneva, MHRA, GCC, NPRA Malaysia
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
Cohance is committed to a sustainable future with ambitious goals:
At Cohance, ESG is our promise to go above and beyond, shaping a sustainable future for health science through passion, expertise, and unwavering responsibility.
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Our great team of more than 1400 software experts.
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Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,
Our great team of more than 1400 software experts.
We’ll help you test bold new ideas while sharing your.
Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,