Advances in recombinant DNA technology and gene editing systems have revolutionized the production of pharmaceutical proteins, allowing for the engineering of improved microbial strains through the addition or deletion of specific genes. The enhancement of microbial strains for the over-production of industrial products marks the foundation of all commercial fermentation processes.
Optimized Production Platform
At Creative Biogene, we utilize a diverse array of microorganisms to produce recombinant proteins for clinical and commercial applications. Our state-of-the-art fermentation facility is compliant with current Good Manufacturing Practices (cGMP), ensuring efficient solutions for large-scale recombinant protein manufacturing.
As a leading biotech Contract Development and Manufacturing Organization (CDMO) specializing in microbial fermentation, we possess extensive fermentation capacity and advanced technologies. Our experienced team is adept at handling a variety of recombinant expression projects, from trial expressions of target proteins to large-scale production of antibodies and enzymes.
We support clients from scientific research institutes to pharmaceutical enterprises by offering optimized expression strains for fast and high-yielding recombinant proteins, including Growth Factors, Immune Checkpoints, Cytokines, Chemokines, and Hormones. The benefits of our microbial fermentation-based GMP manufacturing include faster development timelines, higher yields, improved consistency across batches, better scalability, and reduced production costs.
Microbial Expression Systems for Pharmaceutical Protein Production
Creative Biogene offers various microbial expression systems to cater to the specific needs of your pharmaceutical protein production:
- E. coli Gene Expression Service: A reliable option for producing proteins efficiently.
- Yeast Gene Expression Service: Ideal for post-translational modifications and complex proteins.
- Bacillus Subtilis Gene Expression Service: Suitable for secretory production of proteins.
- Corynebacterium Gene Expression Service: Offers advantages in commodity and specialty compound production.
- Filamentous Fungi Gene Expression Service: Perfect for the production of enzymes and secondary metabolites.
- Pseudomonas Fluorescens Gene Expression Service: Focused on environmental and industrial applications.
- Virus-like Particle Gene Expression Service: For developing vaccines and immunogenic proteins.
- Mycobacterium Gene Expression System: Tailored for specialized antibiotic production.
- Staphylococcus aureus Gene Expression System: A promising system for various biopharmaceuticals.
Our Recombinant Pharmaceutical Protein Production Services
- Gene Cloning and Expression System Development:
Tailored development of the optimal expression system (e.g., bacterial, yeast, mammalian) to maximize protein yield and quality. - Strain Selection and Development:
Effective strategies for selecting and constructing chassis strains to produce a diverse range of products. - Media and Process Development:
Optimal formulations to maximize product yields while minimizing undesirable byproducts. - Scale-Up and Process Optimization:
Efficiently transitioning from research-level production to commercial-scale fermentation. - Protein Purification and Quality Control:
Advanced purification strategies, including chromatography techniques, to ensure high-purity protein for clinical use. - Characterization and Validation:
Comprehensive assessment of recombinant proteins to ensure compliance with regulatory standards. - cGMP Manufacturing:
Production under strict cGMP guidelines, ensuring quality for clinical trials and regulatory submissions. - **Regulatory and Compliance Support:
Assistance navigating the regulatory landscape, ensuring compliance with FDA, EMA, and other agencies. - Stability Studies:
Conducting studies to assess shelf life and storage conditions for recombinant proteins.
Our Strengths
- Extensive gene synthesis and cloning capabilities
- Comprehensive chromatography selection
- Effective purification techniques
- Systematic methodologies for solubility improvement
- High-throughput and large-scale fermentation experience
With our advanced expertise in recombinant protein production, we are committed to providing flexible, scalable, and high-quality solutions tailored to meet the evolving needs of the pharmaceutical industry.
For more information about our Recombinant Pharmaceutical Protein Production services and to discover how we can assist you in accelerating the development and commercialization of your recombinant pharmaceutical proteins, please contact us today.
