Development &manufacturing

End-to-End Contract Development and Manufacturing

With >10 years of expertise in peptide synthesis and API development, Yifan Biopharma has proudly completed over 30 successful CDMO projects. We deliver comprehensive, end-to-end solutions—from custom peptide synthesis strategy, API process development, sterile injectable formulation, and cGMP-compliant analytical testing service.
Using world-class quality systems, flexible manufacturing capabilities, and unwavering regulatory excellence, Yifan Biopharma shorten your project timelines, ensures product quality and compliance, and help clients rapidly advance from clinical development to commercial launch—successfully reaching global markets such as U.S. and Europe.

Supporting your peptide project from discovery, over development, all the way to commercial launch — with available capacity and a proven track record in GMP manufacturing.

Team advantage

The core team members have accumulated more than 10 years of research and development experience in the field of peptides.

Technical strength

Rich practical experience in solving difficult sequences.

Industry cooperation

We have established cooperative relations with a number of internationally renowned pharmaceutical companies and research institutions, and successfully undertaken a number of drug development projects.

Customized service

To provide customers with flexible customized projects, to be able to quickly deliver high-quality products.

Preclinical & Clinical Development

Flexible manufacturing solutions, including non-GMP and GMP batches, to support preclinical and clinical development phases.

Comprehensive scale-up, process optimization & validation services to ensure robust, reproducible peptide manufacturing processes.

We offer method development, validation, and stability studies to support product characterization and regulatory readiness.

Expert preparation of CMC documentation for clinical Phases 1 to 3, aligned with international regulatory requirements.

Our team conducts comprehensive long-term and accelerated stability studies to ensure your product’s shelf life during the clinical phase and beyond

Dedicated project managers ensure transparent communication, clear timelines, and seamless delivery of your project from start to finish.

Commercial Manufacturing

We offer scalable GMP peptide manufacturing to meet commercial supply needs with unwavering consistency and quality. Our facilities are equipped for high-throughput production while maintaining strict adherence to cGMP guidelines. With free SPPS capacity and robust batch-to-batch reproducibility, we’re ready to support your product launch and beyond.

We provide hands-on support for regulatory submissions, including preparation of technical documentation and response strategies for agency queries. Our experience with global regulatory bodies ensures smoother, faster approval processes for your peptide-based products.