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Small Molecule
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Small Molecule Development
Overview
At Cohance Lifesciences, we bring scientific rigor and operational agility to the development of small molecule APIs and intermediates. Our end-to-end capabilities span route scouting, process optimization, analytical development, and regulatory documentation—empowering innovators to move confidently from concept to clinic.
With deep expertise across hazardous, moisture-sensitive, and stereoselective chemistries, our dedicated process R&D teams engineer robust, scalable, and cost-effective synthesis pathways. Every step is underpinned by integrated process safety, data integrity, and global compliance, ensuring a smooth transition to GMP manufacturing and regulatory submissions.
Core Development Capabilities
– Route Scouting: Efficient identification of optimal synthetic routes using DoE and feasibility studies.
– Process Development & Optimization: Risk-informed development, impurity profiling, and scalable optimization for cost and purity.
– Analytical Development: Custom methods, impurity markers, validation, and stability-indicating assays.
– Process Safety & Risk Evaluation: State-of-the-art safety studies (RC1, DSC, ARC) to ensure secure scale-up.
– Regulatory Documentation: Comprehensive support for IND, IMPD, and DMF submissions across global markets.
Integrated Development Services
– Early Phase Development: Lab-scale feasibility, synthetic optimization, and impurity identification.
– Scale-Up Readiness: Execution of engineering and validation batches using advanced reactors and process tools.
– Lifecycle Services: Rework/reprocessing studies, solvent recovery, impurity fate, and purge investigations.
– Special Capabilities: Expertise in hazardous reactions, air-/moisture-sensitive chemistries, stereoselective synthesis, and green catalysis.
Why Cohance for Small Molecule Development?
– 100+ scientists dedicated to small molecule R&D
– Experience in 20+ reaction classes (e.g., hydrogenation, cyanation, cryogenics)
– Flow chemistry excellence: PFRs, photo flow, CSTRs
– Integrated safety studies and scalability assessment
– Fully equipped R&D facility at Genome Valley, Hyderabad
Ready to co-develop your next breakthrough molecule?
Schedule a Discovery Discussion
Resource Highlights
– Webinar: De-Risking Early-Phase API Development
– Whitepaper: Green Chemistry in Route Optimization
– Case Study: Accelerated Scale-Up of a Chiral Intermediate
– Blog: The Role of Analytical Precision in Small Molecule Success
Ready to co-develop your next breakthrough molecule?
Schedule a Discovery Discussion
Small Molecule Manufacturing
Overview
Cohance Lifesciencesdelivers globally compliant, GMP-grade manufacturing solutions for small molecule drug substances and intermediates. With a multi-site network of USFDA- and EMA-inspected facilities, we offer flexible production—from gram-scale validation batches to multi-ton commercial supply.
Equipped with flow chemistry, cryogenic systems, and high-pressure reactors, our plants are designed to handle complex, sensitive, and highly potent compounds with precision. Integrated analytics, backward supply chain linkages, and a commitment to continuous improvement make us a trusted partner for quality, scalability, and speed to market.
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.
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.
Why Cohance for Small Molecule Manufacturing?
– Proven scale-up of niche and hazardous reactions
– Integrated analytical, safety, and engineering support
– Fully backward-integrated for supply chain assurance
– Flexible delivery formats: clinical supply, validation batches, and commercial lots
– Continuous improvement and lean practices for cost and time efficiency
From grams to tons—trust Cohance to deliver your small molecule at scale.
Resource Highlights
– Webinar: Navigating Regulatory Audits in Small Molecule Manufacturing
– Case Study: Seamless Tech Transfer of a Multi-Step Synthesis
– Whitepaper: Smart Scale-Up Using Flow Chemistry
– Blog: Building Sustainable API Supply Chains
Antibody Drug Conjugates (ADCs)
Integrated CRDMO Services for ADCs
Overview
At the intersection of complex chemistry and precision biology, Cohance Lifesciences and NJ Bio offer fully integrated CRDMO (Contract Research, Development, and Manufacturing Organization) services tailored for Antibody-Drug Conjugates (ADCs). From payload-linker synthesis to bioconjugation and clinical-scale GMP production, we support every phase of your ADC program—seamlessly and scientifically.
Our CRDMO model is designed for agility, scale, and regulatory readiness—helping biopharma innovators bring safer, more effective ADCs to market, faster.
Core Capabilities
• Chemistry + Biology Integration: Cohesive support across linker-payload synthesis, antibody conjugation, and bioanalytical characterization.
• Innovative Bioconjugation Platforms: Site-specific and traditional conjugation with process optimization.
• Scalable GMP Manufacturing: Phase-appropriate production in state-of-the-art facilities with global regulatory compliance.
• Analytical & Regulatory Support: CMC development, characterization assays, and submission-ready documentation.
Comprehensive Services
• Discovery to IND Support: Synthesis of payload-linker variants, conjugation feasibility, and lead candidate selection.
• Process Development: Route scouting, impurity profiling, DoE optimization, and tech transfer.
• Bioconjugation Development: ADC conjugation using established and proprietary technologies for enhanced stability and targeting.
• GMP Manufacturing: Phase 1–2 clinical supply of ADCs and intermediates; scalability up to commercial levels.
• Integrated Analytics: LC-MS, ELISA, hybrid assays, and NMR for purity, cytotoxicity, and binding characterization.
Why Cohance + NJ Bio?
• Deep ADC domain knowledge spanning chemistry, biology, and manufacturing
• Purpose-built facilities for bioconjugation and HPAPI containment
• Proprietary S-Trione payload platform and CPT derivative expertise
• Agile and collaborative CRDMO partnership with regulatory foresight
Launch your next ADC program with a partner who understands the science, speed, and scale it takes.
Schedule a CRDMO Consultation
Resources Highlights
Webinar: Mastering Payload-Linker Chemistry for ADC Success
Whitepaper: Integrated CRDMO Models for Complex Bioconjugates
Case Study: Seamless Tech Transfer for a Phase 1 ADC Program
Blog: How Site-Specific Conjugation Enhances ADC Potency and Safety
Payload Supply for ADCs
Overview
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.
Core Capabilities
• 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).
Payload & Linker Services
• 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.
Infrastructure Snapshot
• 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.
Why Cohance for Payload Supply?
• 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
Secure your payload supply chain with a partner that delivers innovation, consistency, and confidence.
Resources Highlights
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?
Oligonucleotides
Oligonucleotide Development & Manufacturing
Oligonucleotide Development
Title: Precision Development for Advanced Oligonucleotide Therapeutics
Subheading: From concept to IND—tailored chemistry, scalable support.
Overview
Sapala Organics offers end-to-end development support for oligonucleotide therapeutics, from route scouting to IND-enabling synthesis. With deep expertise in phosphoramidite chemistry and nucleoside modification, we help optimize molecular design and synthesis pathways. Our multidisciplinary team—backed by Cohance Lifesciences—ensures seamless development-to-manufacturing transitions, regulatory readiness, and speed-to-clinic.
Core Development Capabilities
Route ScoutingCustom SynthesisAnalytical DevelopmentRegulatory SupportIntegrated Development Services
Integrated CDMO Services across the Oligonucleotide Lifecycle
• Custom Synthesis
Proprietary and modified nucleic acid building blocks, including high-purity phosphoramidites and heterocyclic scaffolds. Tailored synthesis protocols engineered to client-specific needs. Design of novel delivery compounds to enhance therapeutic targeting.
• Contract Development & Manufacturing
Scalable process development from milligram to multi-kilogram levels. Non-GMP and GMP execution aligned with global regulatory expectations under Cohance’s validated quality systems.
• FTE Services
Full-time equivalent (FTE)-based engagement models for innovators and large global CDMOs, offering deep chemistry support across oligonucleotide and medicinal chemistry programs.
Specialized Products
• Amidites and Nucleosides
Synthesis of a wide range of modified amidites and nucleosides with excellent purity (critical impurities ≤0.2%–0.3%). Several novel protecting groups for sugar and base protection. Specialized building blocks including locked/bridged nucleic acids, FANA, oxime compounds, morpholino compounds, and diastereotopically pure amidites. One of the few CDMOs globally supplying multi-kg quantities of tri-cyclo DNA.
• GalNAc / Drug Delivery Conjugates
Expertise in sugar derivatives, PEG linkers, and lipid chemistry to develop GalNAc-based delivery platforms. Multi-kg scale delivery for clinical-stage customers.
• mRNA Building Blocks
Custom synthesis of Nrl pseudouridine-modified NTPs and cap reagents. Among the few globally to produce N1-Me-pseudouridine chemically at multi-kilo scale.
• Fluorescent Dyes
Multi-kilo production of 6-FAM, TAMRA, Cy3, Cy5, and other diagnostic-grade dyes used in molecular diagnostics and sequencing technologies.
Why Sapala for Oligonucleotide Development?
- India’s only CDMO dedicated to nucleic acid chemistry
- End-to-end integration with scale-up and GMP manufacturing
- Strong track record in supporting discovery to IND transitions
- Agile, client-centric approach to complex oligo challenges
- 100+ years of combined domain expertise
- Collaborative, client-centric approach to complex oligo challenges
- Integrated collaboration with GMP manufacturing units
Let’s co-develop the next breakthrough in oligonucleotide therapeutics.
Oligonucleotide Manufacturing
Title: Scalable GMP Manufacturing for Oligo Building Blocks
Subheading: From grams to commercial scale—precision-built for compliance.
Overview
Backed by Cohance Lifesciences, Sapala Organics delivers GMP-compliant manufacturing of oligonucleotide intermediates at scale. Our infrastructure includes dedicated amidite blocks, ISO-grade cleanrooms, and versatile reactors to support GalNAc compounds, modified nucleosides, mRNA reagents, and fluorescent dyes. With capacity from 100 g to 100+ kg, we support clinical and commercial supply with validated processes and global regulatory alignment.
Manufacturing Infrastructure Highlights
• 600–700 kg/year Capacity at dedicated GMP amidite unit (Nacharam)
• ISO Class 8 / Grade D Cleanrooms with HEPA filtration and RH control for sensitive drying and dispensing
• Versatile Reactor Suite: 10+ reactors (glass, stainless steel, Hastelloy) ranging from 50 L to 1,000 L
• Advanced Equipment: Lyophilizers, Nutsche filters, rotavapors, and large-volume glass columns
• USFDA-Approved Unit 4 being equipped for commercial-scale GMP phosphoramidite manufacturing
• Upcoming Expansion: GMP readiness by September 2025, enabling larger volume delivery for clinical and commercial needs
Integrated Infrastructure for GMP Manufacturing
• R&D Facility (Nacharam)
17 chemistry labs with over 80 fume hoods, plus 8 analytical and instrumentation labs support early-phase development and method transfer.
• Pilot Plant (Nacharam)
12 reactors and capacity up to 100 kg to support multi-step synthesis for scale-up readiness.
• Unit 2 (Jeedimetla)
27,000 L capacity earmarked for commercial-scale amidites and nucleosides production.
• Unit 4 (Nacharam) (USFDA-Approved)
High-end manufacturing site that currently handles ADC payloads for global clients. Now being equipped for large-scale GMP production of phosphoramidites and oligo building blocks.
Dedicated Amidite Block – GMP (Nacharam)
• Annual capacity: 600–700 kg
• ISO Class 8 Cleanroom & Intermediate Area
• RH ≤30% with terminal HEPA filtration
• HVAC with airlocks and full environmental control
• Ready for GMP manufacturing from September 2025
• Equipment:
o Plant Reactors: 50 L – 1,000 L (10 units)
o Kilo Lab Reactors: 10 L – 50 L (4 units)
o Nutsche Filters, Lyophilizers, Glass Columns, Rotavapors
Equipment Showcase
Equipment Type | Capacity/Range |
Plant Reactors | 50 L – 1,000 L (10 units) |
Kilo Lab Reactors | 10 L – 50 L (4 units) |
Nutsche Filters | 25 L – 250 L (3 units) |
Tray Lyophilizer | 50 L (1 unit) |
Glass Columns | 100 L – 200 L (2 units) |
Rotavapors | 1 L – 50 L (3 units) |
Stainless Steel Reactors | 500 L – 1,000 L (3 units) |
Glass-Lined Reactors | 250 L – 630 L (3 units) |
Hastelloy Reactor | 500 L (1 unit) |
Why Partner with Sapala for Oligonucleotide Manufacturing?
- Only Indian CDMO with deep nucleic acid scale-up capabilities
- Proven GMP compliance
- Flexible delivery—from 100 g R&D batches to 100+ kg GMP lots
- Process rigor supported by validated SOPs, batch traceability, and regulatory readiness
- Only Indian CDMO with dedicated infrastructure for oligonucleotide intermediates
- Audit-ready, globally aligned documentation
- Proven execution across GalNAc, fluorescent dyes, and mRNA reagents
- Backed by Cohance Lifesciences’ global compliance framework
Custom-Fit Execution Models
• Integrated CDMO Manufacturing:
Comprehensive services from late-stage development to GMP batch production, ensuring regulatory-aligned manufacturing.
• Flexible Delivery & Engagement:
Choose from fixed-scope or FTE-based models to match your scale, timelines, and internal capabilities.
• End-to-End Accountability:
Combined expertise in complex synthesis and rigorous manufacturing makes Sapala a seamless CDMO partner from development to commercial readiness.
Take your oligonucleotide from pilot to global scale with confidence.
Peer Insights / Resource Section
- Webinar: Scaling Oligonucleotide Therapeutics
- Case Study: From Discovery to Clinical Supply
- Whitepaper: Overcoming Challenges in Phosphoramidite Production
- Blog: Nucleic Acid Chemistry in Next-Gen Therapeutics
Oligonucleotide Products
Oligonucleotide Products
Overview
Sapala Organics offers a portfolio of high-purity oligonucleotide building blocks that power next-generation therapeutics and diagnostics. From amidites and delivery linkers to mRNA reagents and dyes, our products are crafted with precision, backed by scalable manufacturing and stringent quality control.
Product Categories
• Nucleoside and Phosphoramidite Derivatives
Wide range of modified amidites and nucleosides, including locked/bridged nucleic acids, FANA, oxime compounds, morpholino compounds, and diastereotopically pure amidites. Excellent impurity control (≤0.2%–0.3%). Among the few globally supplying multi-kg tri-cyclo DNA.
• Linkers and Spacers
Custom-designed chemical linkers and spacers that enhance the conjugation of oligonucleotides with targeting or delivery molecules, improving therapeutic stability and efficacy.
• PEG Derivatives / GalNAc Conjugates
Sugar derivatives, lipids, and PEG-based linkers developed for targeted oligonucleotide delivery. Multi-kg scale GalNAc synthesis for clinical-stage biopharma partners.
• mRNA Building Blocks
Supply of Nrl pseudouridine-modified NTPs and chemically synthesized N1-Me-pseudouridine at multi-kilo scale. Includes cap reagents for mRNA vaccines and therapies.
• Fluorescent Dyes
Large-scale synthesis of 6-FAM, TET, Cy3, TAMRA, Cy5, and other dyes used in molecular diagnostics, gene sequencing, and imaging platforms.
Why Choose Sapala Products
- Trusted supplier to global biopharma for early- and late-phase needs
- Rapid custom synthesis support
- Consistent supply at R&D and GMP-grade scales
- Backed by in-house development and manufacturing expertise
Looking for high-purity building blocks tailored to your oligonucleotide platform?
Download Product Brochure Talk to a Product Expert
Download Product Brochure Talk to a Product Expert
Catalogue
For a detailed product catalog and specifications, please visit our Products Page.
Equipment Type | Capacity/Range |
Plant Reactors | 50 L – 1,000 L (10 units) |
Kilo Lab Reactors | 10 L – 50 L (4 units) |
Nutsche Filters | 25 L – 250 L (3 units) |
Tray Lyophilizer | 50 L (1 unit) |
Glass Columns | 100 L – 200 L (2 units) |
Rotavapors | 1 L – 50 L (3 units) |
Stainless Steel Reactors | 500 L – 1,000 L (3 units) |
Glass-Lined Reactors | 250 L – 630 L (3 units) |
Hastelloy Reactor | 500 L (1 unit) |
Equipment Showcase
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