Peptides & Peptidomimetics

One Stop Integrated Solution for Peptide Programs

Innovating Peptide Therapeutics for a Healthier Future: One Stop Integrated solution for Peptide program (NCEs, APIs & Formulations Development)

At Shilpa Pharma Lifesciences Limited, we are at the forefront of peptide and peptidomimetics drug development, offering end-to-end solutions from discovery to commercial-scale manufacturing. Our state-of-the-art facilities and expert scientific team enable us to develop complex peptide-based therapeutics with high precision, efficiency, and regulatory compliance.

Our Peptide & Peptidomimetics Capabilities

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Peptide Development to Manufacturing

cGMP and non-GMP manufacturing for preclinical, clinical and commercial requirements including custom peptide product development

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Specialized Peptide Applications

Cosmetic peptides, functional cosmetics, multiple antigenic peptides (MAP's), generic peptides, oncology and non-oncology peptides

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Peptide Synthesis Methods

Solid-phase peptide synthesis (SPPS), solution-phase peptide synthesis (LPPS), and combination hybrid synthesis approaches

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Custom Synthesis & Optimization

Expertise in linear, cyclic, and complex peptides with modifications including PEGylation, lipidation, and conjugation

Advanced Peptide Modifications & Peptidomimetics

Comprehensive Modification Capabilities

C-Terminal & N-Terminal Modifications

• Amidation, peptide alcohols and aldehydes
• C-terminal esters and thioesters
• PEGylation, lipids incorporation
• Acetylation, acylation (lipopeptides)
• Biotinylation, phosphorylation, sulfation

Cyclization & Backbone Modifications

• Single/multiple disulfide bridges
• Head-to-tail and side chain cyclization
• Hydrocarbon-stapled peptides
• D-enantiomer, N-methyl amino acids
• Unusual amino acids incorporation

Process Development & Manufacturing Excellence

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Process Development & Scale-Up

Dedicated team for process optimization, scalable GMP manufacturing from milligram to multi-kilogram levels with cost-effective production

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Advanced Purification

State-of-the-art purification techniques using RP-HPLC, nano-filtration, ultra-filtration for high-purity peptides

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Analytical Characterization

Comprehensive analytical capabilities including LC-MS/MS, HPLC/UPLC, method development, validation, and stability studies per ICH conditions

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Formulation & Drug Delivery

Injectable and oral peptide formulations, nanoparticle and liposomal delivery systems, depot formulations for sustained release

State-of-the-Art Infrastructure

R&D Infrastructure

• Automated peptide synthesizer (aapptech Focus XCi)
• Manual SPPS reactors: 0.5L to 20L capacity
• Preparative HPLC systems with multiple column sizes
• Bottle Lyo 10L/35L Tray Lyophilizers
• Rotary evaporators and analytical HPLC systems

cGMP Manufacturing

• SPPS Reactors: 50L to 3000L capacity
• CEM Microwave synthesizer: 3L/15L
• Large-scale preparative HPLC systems
• Tray Lyophilizers (240L, 600L)
• Nano filtration systems up to 640L per hour

Regulatory Support & Compliance

✓Expertise in IND, NDA, and ANDA regulatory filings with global agencies like USFDA, EMA, and ANVISA
✓CMC support for peptide drug development ensuring full regulatory compliance
✓Robust quality management systems adhering to ICH and GMP guidelines

Why Partner with Shilpa Pharma Lifesciences?

✓Proven expertise in complex peptide and peptidomimetics drug development

✓State-of-the-art R&D and GMP manufacturing infrastructure

✓Regulatory-compliant processes for global market access

✓Cost-effective and scalable solutions from discovery to commercialization

Get in Touch today to explore our peptide and peptidomimetics development capabilities!

At Shilpa Pharma Lifesciences, we are committed to advancing peptide-based therapeutics with innovation, precision, and efficiency.