Protein Drug CDAMO Service

Integrated CMC Services Backed by Over 20 Years of Biopharmaceutical Development Experience

Genexine provides process development, analytical development, manufacturing, and quality/CMC support services for protein therapeutics, drawing on its experience in developing biopharmaceuticals for clinical trials in Korea, the United States, and Europe.
From early-stage research to CMC preparation for nonclinical and clinical development, Genexine provides customized services tailored to each client’s development stage and product characteristics.

Service Capabilities

1. 1

   USP

   Upstream Process Development

   1. · Cell culture process development
   2. · Optimization of culture conditions and processes
   3. · Scale-up to approximately 200 L
   4. · Additional process support through external CRO partnerships, if required
   5. · Support for process development data preparation for IND submission
2. 2

   DSP

   Downstream Process Development

   1. · Purification process development
   2. · Optimization of purification processes
   3. · Scale-up to approximately 200 L
   4. · Additional process support through external CRO partnerships, if required원
3. 3

   Analysis

   Analytical Development & Characterization

   1. · Analytical method development
   2. · Protein characterization
   3. · Support for release testing
   4. · Stability study
   5. · Other analytical services for protein therapeutics
4. 4

   QA

   Quality & Regulatory Support

   1. · Quality Management System (QMS) support
   2. · CMC-related quality management
   3. · Support for CTD documentation
   4. · CMC documentation support for clinical development
5. 5

   GMP Support

   Technology Transfer & Manufacturing Support

   1. · CMO technology transfer support for GMP manufacturing
   2. · Review of batch records related to DS/DP manufacturing
   3. · Technical communication and manufacturing support with CMOs
   4. · GMP manufacturing support for clinical development

Integrated CDAMO Workflow

Protein Manufacturing Capability

Based on its in-house process development capabilities, Genexine provides protein sample production services for nonclinical studies.

Culture scale: up to approximately 200 L
Integrated support from initial process development and scale-up to sample production for nonclinical development

Applicable Molecules

• mAb
• Fusion Protein
• Enzyme
• Recombinant Protein
• Bispecific Antibody
• Other Protein Therapeutics

Why Genexine?

20+ Years of Development Experience

Over 20 years of CMC and process development experience accumulated through domestic and global biopharmaceutical development.

Integrated Expertise

Integrated development capabilities spanning USP, DSP, analytical development, quality, and technology transfer.

Flexible & Customized Service

Customized project design tailored to each client’s development stage, product characteristics, and goals.

From Discovery to Development

End-to-end R&D capabilities from nanobody discovery to protein drug process development and nonclinical sample production.

Accelerate Your Biologic Development with Genexine

From novel nanobody discovery to protein drug development, Genexine supports clients’ drug development programs by leveraging its accumulated R&D experience and expertise.