How JYMed Delivers Integrated, cGMP-Compliant Peptide CDMO Solutions from Discovery to Delivery
Introduction: 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.
Since its foundation in 2009, JYMed Technology Co., Ltd. has grown into a leading global Peptide Solutions Provider with a clear focus on innovation. The company operates three fully integrated facilities dedicated to research and development, cGMP Peptide API manufacturing, and finished Drug Product production. More than 600 professionals, including 130 dedicated scientists, support every project with precision, quality, and partnership.
Step 1. Design and Feasibility in Peptide CDMO Projects
Each project begins with intensive collaboration and rigorous scientific design.
JYMed’s R&D team works within a 7,000 square-meter state-of-the-art laboratory, conducting initial feasibility studies, sequence design, and scalability assessments. With over 3,000 CRO projects and more than 50 CDMO programs completed—including two client Investigational New Drug (IND) filings with the US FDA—JYMed 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.
Step 2. Process Development for Peptide CDMO Success
Efficiency is central to JYMed’s technological capabilities, driving down costs and accelerating time to market.
JYMed’s Synthesis Platforms for Peptide CDMO Manufacturing
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, JYMed ensures high yield, purity, and cost-effective production. This optimized workflow delivers shorter development cycles and greater consistency from lab to manufacturing scale.
Step 3. Scale-Up and cGMP Peptide API Manufacturing
Large-scale production takes place at JYMed’s Hubei API Site, one of the largest peptide manufacturing centers in Asia.
Large-Scale Manufacturing Capabilities at the Hubei API Site
- 30,000 liters of SPPS and LPPS reactor volume
- Ten dedicated cGMP Peptide API production lines
- More than four tons of annual capacity, expanding to ten tons by 2026
- 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.
Step 4. Analytical Development and Regulatory Support (IND, NDA, DMF)
Analytical development is a core strength of JYMed’s CRDMO model, providing the robust data required for global submissions.
Core Services: Analytical Validation and Global Regulatory Filing Support:
<p>Beyond Peptide APIs, JYMed provides complete Drug Product formulation services at its Shenzhen Finished Dosage Form Site.</p>
- 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
JYMed’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.
Step 5. Finished Drug Product Development
Beyond Peptide APIs, JYMed provides complete Drug Product formulation services at its Shenzhen Finished Dosage Form Site.
Integrated Peptide CDMO Formulation Services (Shenzhen Site)
- A syringe line producing up to 30 million vials per year
- A cartridge line with an annual capacity of 10 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.
Step 6. Data Integrity and Confidentiality
Protecting client data and intellectual property is a non-negotiable priority.
JYMed 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.
Step 7. Continuous Innovation and Improvement
Expanding Capacity and Future Drug Delivery SystemsJYMed continues to expand its technological edge through automation, real-time monitoring, and innovative drug delivery systems such as liposomes, polymeric micelles, and nanoparticles.
Ongoing capacity growth to ten tons of peptide API by 2026, along with the integration of advanced digital tools, reinforces the company’s role as a trusted and innovative CDMO partner in global peptide manufacturing.
Conclusion: Choosing a Reliable Peptide CDMO Partner
From discovery to delivery, JYMed Peptide provides a complete and proven CDMO framework that transforms peptide research into reliable, compliant, and scalable manufacturing.
With world-class technology, global quality systems, and an experienced scientific team, JYMed empowers pharmaceutical and biotech partners to accelerate peptide-based therapeutics worldwide.
JYMed Technology Co., Ltd. | A Leading Global Peptide Solutions Provider
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