CDMO For Peptide And Amino Derivatives

Peptide/Amino Acid Derivative CDMO Process - Customization Empowering the Development of Innovative Therapies

The efficacy and stability of peptide drugs (such as semaglutide and tirzepatide) are highly dependent on precise synthesis of side chain modifications and protected amino acids. As a global leading CDMO enterprise in the pharmaceutical industry, we provide efficient and compliant process solutions for GLP-1 receptor agonists, diabetes drugs, and more through Custom peptide synthesis and Amino acid derivative customization technologies.

Core Process Advantages: Precision Modification and Impurity Control

Customized Protected Amino Acids - Flexibility and Purity Assurance

Protected amino acid manufacturing: Providing multiple protection schemes such as Fmoc, Boc, and Alloc, supporting High-purity Fmoc-protected amino acids (purity ≥ 98%).

Rapid Delivery System: From milligram-scale pilot tests to kilogram-scale production, reducing cycle time by 30% to meet preclinical to commercial needs.

Quality Compliance: Double detection using HPLC and chiral chromatography to meet USP/EP pharmacopeia standards.

Overcoming Challenges in Side Chain Customization: From Structural Design to Impurity Elimination

Semaglutide side chain synthesis:

Fatty Acid Anchoring Technology: Utilizing C18 dicarboxylic acid chain modification to extend the drug half-life to 7 days, doubling biological activity.

PEGylation Optimization: Introducing branched PEG to reduce immunogenicity, suitable for Tirzepatide analog synthesis.

Impurity Control: Combining RP-HPLC and high-resolution mass spectrometry to accurately separate structural analogs (e.g., deacylated impurities), achieving purity ≥ 99%, meeting FDA/EMA application requirements.

CDMO Full Process Service: From Development to Global Submission

Customized Development Process

Requirement Analysis: Clarifying the functional objectives of Peptide side chain customization for diabetes drugs (e.g., targeting and stability).

Synthesis Route Design: Utilizing a combination of solid-phase peptide synthesis (SPPS) and liquid-phase fragment condensation to optimize yield and cost.

Process Verification: Conducting DoE experimental design to determine the optimal reaction conditions (temperature, pH, catalyst ratio).

Quality and Compliance System

Analytical Method Development: Establishing multi-dimensional detection methods such as chiral HPLC, NMR, and CD spectroscopy to ensure clear structure-activity relationships for Semaglutide side chain modification service.

Global Registration Support: Providing ICH Q3A/Q7-compliant CMC document packages, including impurity profile studies, stability data, and toxicology reports.

Application Scenarios: Accelerating the Development of Diabetes and Metabolic Drugs

GLP-1 Receptor Agonist Upgrade

Custom synthesis of GLP-1 receptor agonists: Optimizing side chain fatty acid length (C14-C20) to balance lipophilicity and renal clearance rate.

Tirzepatide Intermediate Customization: Developing dual-target (GIP/GLP-1) specific side chains to enhance glycemic control and weight loss effects.

Peptide-Drug Conjugate (PDC) Innovation

Introducing cleavable linkers (such as maleimide) to achieve targeted toxin delivery, reducing systemic toxicity.

Comprehensive Keywords:

Custom peptide synthesis, Amino acid derivative customization, Protected amino acid manufacturing, Semaglutide side chain synthesis, Tirzepatide intermediate customization, High-purity Fmoc-protected amino acids, Custom synthesis of GLP-1 receptor agonists, Semaglutide side chain modification service, Tirzepatide analog synthesis, Peptide side chain customization for diabetes drugs.