Protein production is the biotechnological process of expressing a specific protein, involving multiple key steps such as gene cloning, vector construction, transformation or transfection, protein expression, and purification. As a protein production expert, CD Formulation is proud to provide you with a wide range of protein production services. We use a variety of expression systems and cell types - from E. coli to mammals - to ensure that your target protein achieves optimal protein expression levels. Our team of experienced scientists can take your gene sequence through gene cloning, plasmid construction, and expression constructs, to final protein purification.

What is Therapeutic Protein Production?

Protein production usually involves two key steps, protein expression and protein purification.

• Protein Expression: This process involves inserting the gene encoding a specific protein into the host cell through transfection, transformation, or viral infection. Once the gene is successfully introduced, the host cell will use its own cellular machinery to synthesize the target protein. This step requires optimization of culture conditions, such as temperature, pH, medium composition, etc., to improve expression efficiency and correct protein folding.
• Protein Purification: After protein expression, a large amount of target protein and other cellular components are produced in the cell, so the target protein needs to be separated from impurities through a purification process. The purification steps usually include cell lysis, centrifugation, filtration, precipitation, and chromatographic separation, such as column chromatography.

Fig. 1 Therapeutic protein production. (CD Formulation)

Explore Our Therapeutic Protein Production Services

As a leading protein production contract organization, CD Formulation is focused on providing high-quality therapeutic protein production services to customers around the world. Our professional team has extensive experience in providing customized solutions for a wide range of biopharmaceutical products.

Our therapeutic protein production services cover all steps from DNA synthesis to vector construction to protein production and purification. With advanced in-house protein production and purification platforms, we confidently provide small-scale to large-scale production and purification services for your selected protein. You can choose to use a variety of expression systems to produce your exclusive protein, including but not limited to:

Yeast Expression System-Based Therapeutic Protein Production

Baculovirus-Insect Cell Expression System-Based Therapeutic Protein Production

Escherichia Coli Expression System-Based Therapeutic Protein Production

Mammalian Cell Expression System-based Therapeutic Protein Production

Glyco-Engineering-Based Therapeutic Protein Production

Eukaryotic Algae Engineering-Based Therapeutic Protein Production

Integrated/Single Protein Production Service

We provide one-stop services from gene synthesis to protein purification, including the generation of high-performance strains within a competitive time frame, the development of scalable bioreactor cultivation protocols, and protein purification process optimization, protein formulation process development, and process transfer.

Protein Expression System Development Service

The purpose of protein expression is to obtain a large amount of protein. In order to obtain enough target protein, our scientists usually use a variety of technologies to increase the expression of the protein, including selecting a suitable expression system, optimizing vectors, gene optimization, fusion systems, co-expression, mutagenesis, and isotope labeling.

Protein Purification Service

• Protein purification is the separation of proteins from samples such as cell lysates or culture media, involving protein refolding and fusion partial cleavage. We provide the following protein purification strategies to support your protein production projects.
• Chromatographic Technology: Achieve high purity levels using affinity chromatography, ion exchange and size exclusion chromatography.
• Filtration Methods: Microfiltration and ultrafiltration for concentration and diafiltration processes.

Protein Production Service

• Scale-up: From small-scale laboratory production to large-scale bioreactor settings.
• Process Optimization: Fine-tune conditions (temperature, pH, and culture medium) to obtain optimal protein yields.

Formulation Development Service

• Buffer Optimization: Develop optimal buffer conditions to maintain protein stability and activity.
• Additives and Stabilizers: Evaluate excipients such as surfactants, stabilizers, and cryoprotectants to enhance protein formulations.
• Lyophilization: Develop freeze-drying processes to produce stable protein formulations.

Characterization and Analytical Services

• Quality Control Testing: Ensure proteins meet regulatory standards through activity, purity, and safety analysis.
• Biophysical Characterization: Analyze protein structure and interactions using techniques such as NMR, mass spectrometry, and circular dichroism.

General Steps for Therapeutic Protein Production

Fig. 2 General steps for therapeutic protein production. (CD Formulation)

• Gene Cloning: First, the gene encoding the target protein needs to be isolated from the natural organism. This can be done by methods such as polymerase chain reaction (PCR).
• Vector Construction: The cloned gene is inserted into a suitable expression vector, commonly used vectors include plasmids. These vectors usually contain promoters, resistance genes, etc., to ensure its effective expression in the host cell.
• Transformation or Transfection: The recombinant vector is introduced into the host cell, which can be bacteria, such as E. coli, yeast, insect cells or mammalian cells. The specific choice depends on the nature of the target protein and the required post-processing.
• Protein Identification and Characterization: Once the vector is successfully introduced into the host cell, the cell will begin to synthesize the target protein using its own transcription and translation machinery. During this process, the protein yield and activity can be optimized by adjusting the culture conditions (temperature, culture medium, inducer, etc.), and it can be identified and characterized.
• Protein Separation and Purification: After large-scale fermentation, the protein needs to be extracted, usually through steps such as cell lysis and centrifugation. The extracted proteins usually need to go through a series of purification steps to remove impurities, including affinity chromatography, ion exchange chromatography, and gel filtration chromatography.
• Protein Folding and Modification (Optional): Some proteins need to be folded and post-modified, such as glycosylation and phosphorylation, in vitro to obtain their native activity.

Our Technology Platforms

Why Choose Our Therapeutic Protein Production Services?

• Our team consists of highly skilled scientists and technicians with many years of experience in protein production, allowing for a tailored approach to your specific goals, timeline, and budget.
• We have cutting-edge technologies and advanced platforms for protein expression and purification, including E. coli, yeast, insect, and mammalian cell systems.
• Our services are highly customizable to meet your specific goals, whether you are developing therapeutic proteins, antibodies, or other biologics.
• We have a high-yield cell line culture and continuous perfusion culture cell culture platform that is recognized and validated by global regulatory agencies to meet the production of proteins with different properties.
• We adhere to strict quality control measures throughout the production process. Our commitment to quality ensures that the proteins we produce meet or exceed regulatory requirements.
• We provide scalable solutions, whether you need small-scale production for research purposes or large-scale production for clinical trials.
• Our optimized protocols reduce production time, speed up the development process, and bring your product to market faster.

Publication

With CD Formulation, you can continuously produce your custom proteins as part of larger-scale biotherapeutic drug discovery campaigns. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.