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Cohance Lifesciences is a global frontrunner in the development and supply of high-potency payloads and linkers for Antibody-Drug Conjugates (ADCs). With deep expertise in Camptothecin (CPT) derivatives and proprietary s-Trione scaffold, we offer customizable payloads with high cytotoxicity, efficient conjugation, and scalable synthesis.
Our capabilities span from early-stage R&D to GMP-compliant commercial manufacturing, all under rigorous global standards for quality, containment, and regulatory compliance. We specialize in handling ultra-potent compounds with occupational exposure limits (OEL) as low as ~10 µg/m³.
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.
Flexible volumes from gram to multi-ton capacity across multiple sites.
USFDA-, EMA-, and PMDA-approved sites with validated processes and full traceability.
Flow reactors, high-pressure systems (up to 20 kg/cm²), cryogenic capabilities (-70°C), and automation.
200+ DMFs filed globally; extensive experience in audits and global market readiness.
Support for reprocessing, impurity purge, solvent recovery, and green manufacturing practices.
Advanced synthetic routes for Exatecan Mesylate, SN-38, Irinotecan, Topotecan, 10-Hydroxy Camptothecin, and more, with integrated supply of intermediates like (s)-Trione (CAS# 110351-94-5).
Active Drug Master Files (DMFs) for S-Trione (US DMF 039042), SN-38 (US DMF 039031), Irinotecan (CEP 2023-338) and with upcoming DMFs for Exatecan, Dxd, Belotecan and MMAE.
Engineered payloads with superior stability and therapeutic index, enabling precision-targeted ADCs.
Optimized processes for Monomethyl Auristatin E (MMAE), ensuring impurity control and batch consistency.
Multi-kilogram production in specialized cytotoxic facilities, supporting both clinical trials and commercial supply.
Tailored derivatives based on cytotoxicity profile and linker compatibility.
Maleimide, hydrazone, and proprietary cleavable/non-cleavable linkers.
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.
Cohance Lifesciences offers end-to-end payload and linker development tailored to the evolving needs of Antibody-Drug Conjugates (ADCs). Our services combine scientific precision with scalable manufacturing to ensure consistency, safety, and regulatory compliance.
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.
Our early-stage R&D and kilo labs are designed to support route scouting, process development, and scale-up studies.
Designed to seamlessly scale from clinical to commercial manufacturing, these facilities are compliant with global regulatory standards including the US FDA.
Equipped for high-potency manufacturing, this facility features:
• Reactors: Stainless steel (1,500 L) Glass-lined (630 L) and various small reactors
• Drying Systems: Agitated Nutsche Filter Dryers (ANFDs, 350 L) and vacuum tray dryers (6 trays)
• Particle Size Reduction: Jet mills (100 mm) and multi-mills (10–24 kg/hr)
• Containment: Isolators for sampling, dispensing, and powder processing
• Containment Design: Negative pressure environments (-75 to -125 pa)
• Air Handling: Dynamic pass-boxes and BIBO HEPA-filtered AHUs
• Cleanroom Classification: Maintained at ISO-8 standards
• Personnel Flow: Dedicated entry/exit routes with mist showers
• Access Control: Door interlocks
• Environmental Safety: Integrated detoxification systems for effluent treatment
Engineered payloads with superior stability and therapeutic index, enabling precision-targeted ADCs.
Optimized processes for Monomethyl Auristatin E (MMAE), ensuring impurity control and batch consistency.
Multi-kilogram production in specialized cytotoxic facilities, supporting both clinical trials and commercial supply.
Tailored derivatives based on cytotoxicity profile and linker compatibility.
Maleimide, hydrazone, and proprietary cleavable/non-cleavable linkers.
Navigating Regulatory Audits in Small Molecule Manufacturing
Smart Scale-Up Using Flow Chemistry
Seamless Tech Transfer of a Multi-Step Synthesis
Building Sustainable API Supply Chains
Navigating Regulatory Audits in Small Molecule Manufacturing
Smart Scale-Up Using Flow Chemistry
Seamless Tech Transfer of a Multi-Step Synthesis
Building Sustainable API Supply Chains
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.
We’ll help you test bold new ideas while sharing your.
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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.
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