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