Peptide Pharma Service – End-to-End, Regulatory-Compliant, and Scalable API Manufacturing

As a Manufacturer & Solution Provider, Lianhe Aigen delivers integrated Peptide Pharma Services, supporting global pharmaceutical companies from preclinical research to commercial API production.

Why Peptide Pharma Service Matters

Peptides are critical therapeutic molecules with growing importance in drug development. Partnering with a reliable Peptide Pharma Service provider ensures consistent quality, regulatory compliance, and scalable manufacturing throughout the drug development lifecycle.

Lianhe Aigen provides comprehensive Peptide Pharma Services, covering:

Preclinical peptide supply for early-stage research
Clinical-stage peptide manufacturing for IND-enabling studies
Commercial-scale peptide API production for global markets

As a trusted Manufacturer & Solution Provider, we enable seamless integration from RSM to Drug Substance to commercial API supply, delivering regulatory-ready, risk-controlled, and scalable solutions.

Our Peptide Pharma Capabilities

Lianhe Aigen’s Peptide Pharma Services include:

Preclinical peptide supply: supporting early-stage discovery with reproducible quality
Clinical-stage peptide manufacturing: scalable, controlled processes for clinical trials
Commercial-scale peptide API production: reliable supply for regulatory-approved APIs
Process development & optimization: reproducible, risk-controlled manufacturing for complex and long-chain peptides
Integrated CRDMO platform: seamless handover from RSM to Drug Substance to commercial APIs

Comprehensive Peptide Solutions

1. Custom Peptide Synthesis:

Expertise in synthesizing peptides of varying complexity, including linear, cyclic, and modified peptides.

Advanced techniques for high-purity peptide production, tailored to client specifications.

2. Peptide Drug Development:

Support for preclinical research and formulation development.

Peptide APIs for clinical trials, adhering to stringent regulatory standards.

3. Specialized Platforms for Peptide Synthesis:

Solid Phase Peptide Synthesis (SPPS): Efficient synthesis of short and long peptides with high yield and purity.

Liquid Phase Peptide Synthesis (LPPS): Cost-effective solutions for large-scale peptide production.

Hybrid Approaches: Combining SPPS and LPPS for optimized manufacturing processes.

4. Peptide Modification Expertise:

Chemical modifications, such as phosphorylation, glycosylation, and PEGylation, enhance stability and activity.

Conjugation of peptides to carriers or linkers for targeted delivery systems, including ADCs and PROTACs.

5. High-Quality Manufacturing Standards:

GMP-compliant manufacturing facilities approved by global regulatory authorities (FDA, EMA, PMDA, etc.).

Comprehensive quality control with advanced analytical techniques, including HPLC, MS, and NMR.

6. Regulatory Support and Documentation:

Full support for regulatory submissions, including DMFs and CTD dossiers.

Expertise in global compliance to ensure a smooth approval process for clinical and commercial use.

Quality & Regulatory Compliance

Quality and compliance are central to our Peptide Pharma Service:

Fully compliant with GxP regulations and ICH Q7 guidelines
Facilities successfully inspected by FDA, EMA, PMDA, TGA, KFDA, NMPA
Complete traceability of raw materials and intermediates
Robust change control and deviation management systems
Support for customer audits and regulatory filings

Our quality system ensures every batch is risk-controlled, consistent, and ready for regulatory submission.

Typical Project Scenarios

We deliver high-quality peptide manufacturing across project needs:

Preclinical-stage peptide supply for early drug candidates
Clinical-stage peptide manufacturing for IND-enabling studies
Commercial-scale peptide API production for regulatory-approved APIs
Technology transfer and process scale-up for reproducible commercial manufacturing

Why Partner with Lianhe Aigen

As a Manufacturer & Solution Provider, Lianhe Aigen combines:

End-to-end CRDMO capabilities covering RSM, Drug Substance, and commercial peptide APIs
Proven record with FDA, EMA, PMDA, TGA, KFDA, NMPA inspections
Long-term, risk-controlled peptide API supply for global pharmaceutical clients
Experienced team in process development, quality assurance, and regulatory compliance

Your Partner in Peptide Innovation

At Lianhe Aigen, we are committed to advancing peptide therapeutics through cutting-edge technology, scientific expertise, and a customer-centric approach. By integrating our capabilities in peptide design, synthesis, and manufacturing, we help our clients accelerate drug development and achieve their goals efficiently and cost-effectively.

Contact us today to explore how our Peptide Pharma Services can support your pharmaceutical innovation and bring your peptide-based therapies to life.