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GMP-Grade Peptide NCEs and Oligopeptide
Peptide Drugs and Oligopeptide
Our team of genetic engineers is developing gene therapies for a range of genetic diseases. We use CRISPR/Cas9 technology and other cutting-edge techniques to create therapies that have the potential to cure genetic diseases.
Combining innovative peptide science and flexible GMP manufacturing capabilities. Tirzepatide Pharma offers GMP-compliant synthesis services for peptide NCEs and commercial peptides. We offer GMP-compliant synthesis services for peptide NCEs and commercial peptides. We provide optimized and scaled-up drug substance. Our peptide development and manufacturing platform provides comprehensive CRDMO/CMO services, capable of handling a diverse range of peptide projects.
Our Services
High-Performance Liquid Chromatography (HPLC) Purification Services for Tirzepatide API
Tirzepatide Pharma provides industry-leading preparative HPLC drug purification services, specifically engineered for complex synthetic peptides and Large Molecule Active Pharmaceutical Ingredients (APIs). Our facility operates under strict current Good Manufacturing Practice (cGMP) standards to ensure the highest levels of purity, safety, and regulatory compliance for your clinical and commercial pipelines.
Precision Peptide Purification
We specialize in the isolation and purification of GLP-1 and GIP receptor agonists. Our Reverse-Phase HPLC (RP-HPLC) platforms are optimized to remove closely related impurities, truncated sequences, and trifluoroacetate (TFA) counter-ions, ensuring a final product that exceeds 99% purity specifications.
Key Service Features:
- Scalable Preparative HPLC: From gram-scale clinical trials to multi-kilogram commercial API manufacturing.
- High-Resolution Fractionation: Advanced column chromatography techniques to achieve maximum yield without compromising molecular integrity.
- Method Development & Validation: Custom analytical method validation according to ICH Q2(R1) guidelines to support your Regulatory Filing (DMF/ASMF)..
CMO-Contract Manufacturing Organization
As a trusted contract development and manufacturing organization (CDMO) partner, Zeptide Pharma combines research and development (R&D), formulation, and scalable manufacturing to meet your unique needs. With a focus on quality and speed, we provide seamless support throughout the lifecycle of your product.
Zeptide Pharma offers comprehensive process development services to identify and optimize the most efficient and scalable processes for New Chemical Entities (NCEs), Advanced Intermediates, and Key Starting Materials (KSMs). Our approach is centered around customer requirements, ensuring that every stage of development aligns with their goals for reproducibility, consistent quality, robustness, production-friendly cost-effectiveness, and regulatory compliance.
Drug product development services provide unparalleled expertise and cutting-edge facilities, designed to meet the most stringent industry standards. Our advanced development center is equipped with specialized analytical and formulation laboratories, enabling precise and efficient drug formulation. Complemented by GMP-accredited manufacturing suites, we ensure that every product adheres to the highest quality and regulatory standards. We are committed to providing end-to-end solutions that accelerate the success of your drug products, with a focus on quality, innovation, and efficiency at every stage.
Keywords: Tirzepatide API, HPLC Purification Service, GMP Peptide Manufacturing, Preparative Chromatography, Clean Room API Processing, GLP-1 Agonist Production, ISO Class 5 Clean Room, Drug Isolation and Purification, Pharmaceutical Scale-up, Lyophilization Services.