CMC Process Development Platform

Comprehensive regulatory support to ensure quality and compliance throughout the lifecycle of biologics

Our Services

Let's Drive Biologic Innovation with Integrated CMC Services

CMC (Chemistry, Manufacturing, and Controls) development is a critical part of drug development, encompassing process development, quality control, stability studies, and regulatory compliance across the entire lifecycle—from R&D to commercialization.

Need help?

Reach out to learn how our microbial CRDMO solutions can support your project.

What we do

Providing One-Stop CMC Development Service Platform

01.

Microbial Cell Line Development&Cell Banking

01. Microbial Cell Line Development&Cell Banking

Providing codon optimization, plasmid construction, expression strain development, and high-yield strain screening services — based on supplied amino acid or DNA sequence
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02.

Upstream&Downstream Process Development

02. Upstream&Downstream Process Development

Integrated process development with microbial expression systems, covering cell banking, fermentation, purification, formulation, quality analysis, technology transfer, and validation
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03.

Formulation Process Development

03. Formulation Process Development

Comprehensive formulation development for biologics, offering fill-finish options such as lyophilized and liquid vials, pre-filled syringes, and cartridges
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04.

Quality Research and Analysis

04. Quality Research and Analysis

Offering comprehensive quality analysis for biologics, including method development and validation, stability studies, and reference standard establishment
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Why Choose us

Built for Reliability
Designed for Clients

We provide flexible, end-to-end microbial CRDMO solutions, backed by extensive project experience, a professional team,
and full GMP-compliant production capabilities.
Rich Project Experience

Successfully served over 200 projects, spanning preclinical research and Phase I, II, and III clinical trials.

Professional Team

Led by a senior CRDMO management team with deep industry expertise.

Scalable Production Capacity

Fermentation capacity ranging from 2L to 2000L to support projects of varying scales and development phases.

Regulatory Compliance Assurance

Fully aligned with GMP regulations and global quality standards, including NMPA, EMA, and FDA.

Flexible Collaboration Models

Tailored cooperation based on client needs, offering agility, transparency, and efficiency.

One-Stop CRDMO Solutions

Comprehensive CRDMO solutions from microbial cell banking to drug product manufacturing.

WANT TO LEARN MORE?

Discover Our Expertise

Explore our tailored CRDMO services and innovative solutions designed to support your biologics development
from concept to commercialization.

CRDMO Modalities

We provide one-stop CRDMO solutions for biologics, with a strong focus on recombinant proteins, plasmids, nano-bodies, and novel recombinant vaccines.

CRDMO Solutions

We provide comprehensive CRDMO services—from CMC process development to MAH-based commercial production—enabling the full journey from DNA to commercialization.

News&Article

Access the latest updates on company news, events, and technical articles.

FAQ

Frequently Ask Questions

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Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.

Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.

Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.

Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.