Peptide Drug Process Research Service

In the quest for new therapeutic strategies, peptides hold a distinct position due to their high specificity and affinity. As short chains of amino acids, peptides can mimic and modulate biological processes, making them ideal candidates for crafting drugs with fewer side effects compared to traditional small-molecule pharmaceuticals. Historically, peptide-based drugs faced challenges such as stability and delivery, but advances in technology have mitigated these obstacles, leading to a renewed interest and growth in peptide therapeutics. With a strong foundation in peptide chemistry, our company is at the forefront of this cutting-edge field. Our peptide drug process research service support pharmaceutical companies and research institutions in navigating the complex landscape of peptide drug development, from route design to regulatory support.

Service Overview

Our company provides a comprehensive and systematic service to peptide drug process development, which includes:

• Route Development: This includes the development of synthetic processes, purification processes, and lyophilization processes.
• Methodology Research: This includes analytical methods development, analytical methods validation, and analytical methods transfer.
• Process Optimization: This involves the study and adjustment of main process parameters.
• Quality Study: This includes impurity synthesis and standardization, impurity structure confirmation, and product quality study.
• Process Validation: This covers material testing and release, validation batch production, release testing, and documentation review.
• Stability Study: This includes stress testing, forced degradation testing, accelerated stability study, long-term stability study, and packaging compatibility testing.
• Supplemental Studies: This encompasses genotoxic impurity studies, change assessment, deviation studies, etc.
• Registration and Submission: This involves eCTD format submission materials, documentation review, and release, among others.

Our Peptide Process Development Capacities

Our expertise extends across a wide spectrum of peptide types. These include:

• Linear peptides
• Long peptide
• Modified peptide
• Complex peptide such as peptide nucleic acid (PNAs), peptoids, peptidomimetic peptides, branched peptides and dendrimers.
• Peptide conjugates such as peptide drug conjugate (PDC), radionuclide drug conjugate (RDC) and peptide oligonucleotide conjugate (POC).
• …

Our Advantages

• Expertise and Experience: Our team comprises seasoned scientists with a deep understanding of peptide chemistry and process study.
• Client-Focused Solutions: We tailor our services to meet the specific needs of each client, providing personalized attention and bespoke solutions.
• Comprehensive Support: Beyond research and development, we offer support in regulatory submissions, intellectual property strategy, and post-market surveillance, ensuring full-cycle partnership.
• Quality and Reliability: With a rigorous quality control system, we can deliver reliable results consistently, underpinning the success of our clients' projects.

It should be noted that our service is only used for research, not for clinical use.