Therapeutic Protein Production & Engineering

Protein production and engineering are key tools for designing, optimizing, and producing effective protein therapeutics with improved affinity, pharmacokinetics, and productivity. As protein experts, CD Formulation focuses on providing a full range of protein production and engineering services. Our team of scientists has deep expertise in protein production and engineering and can provide solutions for the most challenging projects.

About Protein Production & Engineering

Protein production and engineering is a multidisciplinary field that combines the principles of biochemistry, molecular biology, genetics, and bioinformatics to design, produce, and analyze proteins for a variety of applications in different research fields. This technology provides strong support for the development of new therapeutic proteins and has been widely used in the development and production of a variety of therapeutic proteins, such as monoclonal antibodies, enzyme replacement therapy, and vaccines.

Fig. 1 Engineering the protein secretory pathway for programmable secretion of pre-translated therapeutic proteins. (Wang T, et al., 2024)

Explore Our Therapeutic Protein Production & Engineering Services

Therapeutic protein production and engineering is a key component of biopharmaceutical development, including monoclonal antibodies, enzymes, vaccines, and other biologics, involving all stages from protein design to large-scale production, purification, and characterization.

At CD Formulation, we use advanced technologies and methods such as recombinant DNA technology, site-directed mutagenesis, protein expression system optimization, and purification processes to ensure that the produced proteins have optimal functional properties and production efficiency. Our team of scientists has many years of experience in providing protein development and production services, from proof-of-concept studies to pilot production to batch production.

Therapeutic Protein Production

We provide one-stop services from gene synthesis to protein purification, covering all steps from DNA synthesis to vector construction to protein production and stable line construction. You can choose to use the following expression systems to produce your own protein.

• Yeast Expression System
• Baculovirus-Insect Cell Expression System
• Escherichia Coli (E. coli) Expression System
• Mammalian Cell Expression System
• Glyco-Engineering
• Eukaryotic Algae Engineering

Therapeutic Protein Engineering

When natural proteins are used in pharmaceutical products, they often need to be engineered to obtain improved functional and/or structural properties. We can customize and optimize your biotherapeutic lead drug candidate by using protein engineering technologies to potentially improve the structure, activity, and manufacturing properties of the drug candidate. Our protein engineering technologies include:

• Protein Mutagenesis
• Protein Modification and Labeling
• Protein Mutation Library Construction

Downstream Support Services for Therapeutic Protein Production

Therapeutic protein downstream processing involves the recovery, purification, and preparation of the final therapeutic protein from cell culture. Our broad portfolio of downstream processing services is designed to provide versatile and reliable support for custom protein production and development.

Our therapeutic protein downstream processing services include:

Protein Isolation and Purification

• Chromatography: Isolate target proteins from complex mixtures using various chromatography techniques such as affinity, ion exchange, size exclusion, etc.
• Filtration: Concentrate and diafilter proteins using tangential flow filtration (TFF) and ultrafiltration.
• Precipitation: Initial protein concentration and purification using ammonium sulfate or other precipitants.

Formulation Development

• 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.

Quality Control and Characterization

• Analytical Techniques: Implement techniques such as HPLC, SDS-PAGE, and MS for protein characterization.
• Bioassays: Perform functional assays to evaluate the efficacy of protein products.
• Stability Studies: Perform stability tests under various conditions to evaluate shelf life and storage requirements.

Scale-up and Process Development

• Process Optimization: Improve purification and formulation processes based on small-scale results to enable larger-scale production.
• Automation: Utilize automation platforms for high-throughput purification and analysis.

Why Choose Our Therapeutic Protein Production & Engineering Services?

• Our team consists of skilled scientists and engineers with extensive experience in therapeutic protein production and engineering, mastering the most advanced protein science and biotechnology.
• We have best-in-class technologies and methods, including recombinant DNA technology, high-throughput screening, and state-of-the-art production systems, to develop and produce proteins with high purity, high yield and high stability.
• Our services are customizable, allowing us to create targeted solutions that meet specific therapeutic goals and accelerate product development.
• We provide scalable solutions, from small-scale production for research to large-scale manufacturing for clinical and commercial applications. This flexibility supports your growth and adapts to your needs.
• Our rigorous quality assurance protocols ensure that each protein product meets industry standards and regulatory requirements. We implement comprehensive testing at every stage of production to guarantee efficacy and safety.
• Fast Turnaround Time: With streamlined processes and efficient project management, we provide a fast timeline for protein production, allowing you to quickly move from research to clinical trials.

Publication

CD Formulation is an industry leader in protein production and engineering services. Our goal is to meet your specific needs by providing highly customizable services. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.