The Critical Role of Peptides in Modern Therapeutics
Peptides are reshaping the pharmaceutical landscape, driving innovation across metabolic therapies, targeted cancer treatments, neurological therapeutics, and other key therapeutic areas. Beyond the pharmaceutical sector, peptides also fuel technological advancements in premium cosmetic applications.
Developing these complex molecules requires more than chemistry expertise. It demands a specialized Peptide CDMO partner capable of transforming scientific ideas into commercial reality through reliable, cGMP-compliant, and scalable processes.
The company operates three fully integrated facilities dedicated to research and development, cGMP Peptide API manufacturing, and finished Drug Product production. More than 200 professionals, including 80 dedicated scientists, support every project with precision, quality, and partnership.
Design and Feasibility in Peptide CDMO Projects
Each project begins with intensive collaboration and rigorous scientific design.
Our R&D team works within a 5,000 square-meter state-of-the-art laboratory, conducting initial feasibility studies, sequence design, and scalability assessments. With over 300 CRO projects and more than 20 CDMO programs completed—including two client Investigational New Drug (IND) filings with the US FDA—Yifan Biopharma has extensive experience developing complex structures. This includes long, cyclic, and modified peptides such as PEGylated, lipidated, and glycosylated analogs. This deep technical foundation ensures each peptide is engineered for manufacturability and high performance.
Process Development for Peptide CDMO Success
Efficiency is central to YifanBio’s technological capabilities, driving down costs and accelerating time to market.
The company’s synthesis platform covers all major peptide synthesis technologies:
Solid-Phase Peptide Synthesis (SPPS)
Liquid-Phase Peptide Synthesis (LPPS)
Hybrid and Liquid-Solid Phase Peptide Synthesis (L/SPPS)
Minimum Protecting Group Strategy (MP-SPPS), which reduces reagent consumption and minimizes side reactions
Hybrid-Phase Peptide Synthesis (HPPS) for modular fragment assembly
Through automated screening, Design of Experiments (DoE), and in-house analytical validation, Yifan ensures high yield, purity, and cost-effective production. This optimized workflow delivers shorter development cycles and greater consistency from lab to manufacturing scale.
Scale-Up and cGMP Peptide API Manufacturing
Large-Scale Manufacturing Capabilities at the Hefei API Site
30,000 liters of SPPS and LPPS reactor volume
6 dedicated cGMP Peptide API production lines
Two successful US FDA cGMP audits and two NMPA cGMP audits
Every product is produced under a unified Quality Management System, guaranteeing regulatory compliance and reproducibility from pilot to commercial scale.
Analytical Development and Regulatory Support (IND, NDA, DMF)
Analytical Validation and Global Regulatory Filing Support:
Beyond Peptide APIs, YifanBio provides complete Drug Product formulation services.
Analytical method development and full validation
Stability and impurity profiling
Two-dimensional LC online desalting for complex impurity identification
Integration of statistical modeling for robust analytical performance
Yifan’s regulatory expertise covers IND, NDA, DMF, and CEP documentation, supported by a proven record of FDA, EMA, and NMPA approvals. This comprehensive support guarantees seamless advancement from early development to global registration.
Finished Drug Product Development
Integrated Peptide CDMO Formulation Services:
A syringe line producing up to 10 million vials per year
A cartridge line with an annual capacity of 2 million units
A freeze-dryer line for 5 million lyophilized vials
Four GMP-certified formulation lines
These facilities enable the development and production of injectable formulations, including lyophilized powders and prefilled syringes, all managed under strict aseptic control.
Data Integrity and Confidentiality
Protecting client data and intellectual property is a non-negotiable priority.
YifanBio maintains a secure digital infrastructure featuring:
Electronic Lab Notebook (ELN) systems with centralized access management
Cloud Desktop Environment with automatic encryption and managerial approval for data access
This framework guarantees data integrity, traceability, and compliance with global regulatory requirements.
