Peptides & peptide drug conjugates (PDC’s)
CRAMSN Research Park provides comprehensive, end-to-end peptide synthesis and manufacturing services, supporting both clinical and commercial-scale production. With deep expertise in solid-phase (SPPS), liquid-phase (LPPS), and hybrid-phase synthesis approaches, we deliver high-quality peptides ranging from linear sequences (up to 40 amino acids) to complex branched peptides and conjugates with lipids, PEGs, carbohydrates, and small molecules.
Our dedicated peptide R&D labs in Hyderabad and commercial GMP manufacturing facility audited by global regulatory bodies including US FDA, MHRA, and PMDA—enable seamless tech transfer, scale-up, and production of up to 10–12 kg per batch of peptide API.
Capabilities Overview
Synthetic Expertise :
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SPPS, LPPS, and hybrid peptide synthesis
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Peptidomimetics, cyclic peptides, cysteine-rich peptides, lactam-bridged peptides
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Peptides with multiple disulfide bridges, stapled peptides, and fluorescent/dye-labeled peptides
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Custom peptide-linker synthesis for drug conjugation applications
Production Scale :
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Current SPPS Scale-up: 10 kg input & 30–35 kg RBP (resin-bound peptide) output
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Global deprotection: 20 kg input → 10 kg output
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API Batch Sizes: 20–39 amino acids → 1.2 kg per batch
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Facility supports ~10 kg peptide API per batch
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Planned scale-up to 25 kg input → 70–75 kg RBP output
Lab Infrastructure & Equipment
Peptide Synthesizers & Reactors
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Liberty Pro Peptide Synthesizer (25 L)
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Automated microwave peptide synthesizers (lab & commercial scale)
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Manual SPPS reactors (100 mL to 10 L)
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Automated synthesizers (80–160 L) for large-scale peptide production
Purification & Isolation Systems
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Preparative RP-HPLC (150–600 mm columns, 3.3–20 LPH) with PAT blending
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Automated ion-exchange resin systems (Akta Explorer, Akta Prime Plus)
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MPLC system (250 mL/min), gel permeation chromatography
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Crystallization, precipitation, and membrane-based TFF (1 kDa–10 kDa)
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Freeze dryers: 3 L, 1.5 L, and 100 L programmable capacity
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Closed-loop filtration via Hastealloy ANFDs (1 m²)
Analytical Capabilities
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LCMS, GC-MS, LC-ToF, LC Orbitrap, MALDI-ToF
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600 MHz NMR, Circular Dichroism (CD) for secondary structure analysis
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Multi-angle Light Scattering (MALS)
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Charged Aerosol Detector (CAD) for HPLC
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Amino acid analyzer with post-column derivatization
Manufacturing & Regulatory Compliance
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cGMP manufacturing blocks dedicated to peptides and polymers
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Class 100K cleanroom facilities with lyophilization capabilities
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Fully qualified systems for impurity profiling and regulatory submissions
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Manufacturing facilities inspected by US FDA, MHRA, PMDA, ensuring global regulatory compliance
Why CRAMSN for Peptides?
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Broad technical capability—from feasibility and route scouting to commercial manufacturing
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Ability to handle standard, complex, and customized peptide formats
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Seamless integration of synthesis, purification, and analytics
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Proven expertise, infrastructure, and scalability for global clinical supply
Why CRAMSN Peptide Development and Manufacturing Services?
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Extensive knowledge in developing & manufacturing hundreds of complex pharmaceutical products
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Seamless integration from discovery to manufacturing
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Capabilities across a wide range of people molecules
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Large manufacturing capacities with automatic synthesizers
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Rethink processes to ensure better quality in shorter timelines
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Apply new science and technologies, to reduce costs or risk and add innovation
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