Recombinant Protein Expression Service in CHO Cells    

Background

Growth in Biotherapeutics and Diagnostic

Biotherapeutics and diagnostics represent a rapidly growing pharmaceutical sector, encompassing monoclonal antibodies (mAbs), vaccines, hormones, and other proteins. These protein-based products are widely used in both diagnostic and therapeutic applications. Since 2002, the U.S. Food and Drug Administration (FDA) has approved over 300 biopharmaceutical products, with this number continually rising. Meeting the escalating demand for these products poses a significant challenge.

Standardization in Cell Line Use

In recent years, biopharmaceutical companies have begun to favor the use of identical host cell lines for manufacturing and initial clinical trials. This strategy simplifies the cell line development cycle, optimizes the pathway to the clinic, reduces the risk of product comparability issues, and helps manufacturers meet product quality and consistency requirements.

The Choice of CHO Cells

Chinese Hamster Ovary (CHO) cells have been the system of choice for recombinant protein expression since they were first approved for use in recombinant biopharmaceuticals in 1986. CHO cells are widely used for recombinant protein production due to their post-translational modification capabilities similar to human cells and their stable high protein production capacity.

Service Content

Revolutionizing CHO Recombinant Protein Production

Creative Biogene is one of the few companies in the market that can provide services to offer commercial prototype production of monoclonal antibodies, vaccines, fusion proteins, and other biologics. With its state-of-the-art GMP manufacturing facilities and rich experience in CRISPR gene editing technology, Creative Biogene provides one-stop custom development services to global biopharmaceutical and biotechnology companies to ensure efficient and high-quality drug discovery and development.

Our Service Process: From Gene to Purified Protein

Our team can rapidly establish high-yield stable CHO cell populations for protein material production and single-cell cloning for faster delivery. This provides a quicker and more efficient pathway for IND applications, driving project development and accelerating commercialization timelines.

Figure 1. Recombinant Protein Expression Service Process.

1. Gene Synthesis and Optimization

• Design and synthesize optimal DNA sequence based on amino acid sequence.
• Perform codon optimization for enhanced expression in CHO cells.
• Incorporate necessary regulatory elements.
• Quality control: DNA sequencing confirmation

2. Expression Vector Construction

• Select a high-efficiency expression vector suitable for CHO cells.
• Clone-optimized gene sequence into an expression vector
• Incorporate selection markers and tag sequences
• Quality control: Restriction enzyme analysis and DNA sequencing verification

3. Cell Line Optimization and Quality Control

• Screen for high-expressing CHO cell clones
• Establish stable expression cell banks (MCB and WCB)
• Analyze cell growth characteristics and protein expression levels.
• Quality control: Sterility testing, mycoplasma detection, viral testing

4. Small-Scale Expression and Purification Trials 

• Optimize culture conditions (temperature, pH, media formulation)
• Conduct small-scale cultivation experiments.
• Develop preliminary purification methods.
• Evaluate protein yield and quality.

5. Process Optimization and Scale-Up

• Scale up from shake flask to bioreactor cultivation.
• Optimize bioreactor parameters (agitation speed, gas exchange, feeding strategy)
• Establish process control strategies.
• Conduct pilot-scale production validation.

6. Large-Scale Production

• Perform large-scale cultivation using an optimized process.
• Real-time monitoring and control of critical process parameters
• Harvest culture supernatant
• Conduct initial clarification and concentration.

7. Protein Purification

• Execute a multi-step purification process
• Optimize conditions for each purification step.
• Perform viral inactivation and removal treatments.
• Final product concentration and formulation.

8. Final Product Testing and Release

• Conduct comprehensive product quality testing (purity, activity, endotoxin levels).
• Perform product stability studies.
• Prepare product specifications and test reports.
• Quality Assurance department review and release.

9. Quality Control and Documentation Preparation

• Compile all production and testing records.
• Write batch production reports.
• Prepare GMP-related documents (if required).
• Establish a product quality dossier.

Advantage

Key Features and Advantages of Our CHO Recombinant Protein Production Service

Our CHO cell expression systems are continuously optimized to drive innovation, backed by extensive expertise in producing a wide range of complex proteins. We offer flexible solutions, catering to needs from milligram-scale research proteins to gram-scale industrial production, all while maintaining stringent quality control to ensure excellence in every batch.

Contact Us

Whether you're conducting basic research or developing new biotherapeutics, Creative Biogene is your trusted partner. We offer not just services, but comprehensive recombinant protein production solutions. Let's work together to transform your innovative ideas into high-quality recombinant protein products. Contact us to embark on your recombinant protein production journey. At Creative Biogene, every recombinant protein is a key to advancing scientific progress.