When natural proteins are used in pharmaceutical products, they often need to be engineered to obtain improved functional and/or structural properties. Protein engineering helps develop effective protein therapeutics with improved affinity, pharmacokinetics, pharmacodynamics, immunogenicity, and productivity. As a one-stop protein engineering solution provider, CD Formulation can help customize and optimize your biotherapeutic lead candidates. Our protein engineers will provide you with the best combination of computer tools and expertise to potentially improve the structure, activity, and manufacturing properties of your drug candidates.

What is Protein Engineering?

Protein engineering is the process of designing, modifying, and optimizing proteins to achieve specific functions or improve their performance. It combines principles from disciplines such as biochemistry, molecular biology, computational biology, and physics to manipulate proteins at the molecular level. The main goal of protein engineering is to identify specific changes in amino acid sequences and alter such sequences to obtain desired functional properties. Typically, this is achieved by using directed evolution techniques to generate a large number of random mutations in proteins and using appropriate screening systems to select improved variants.

Fig. 1 Protein engineering approach. (Sarah Oluwatobia O, et al., 2023)

Explore Our Therapeutic Protein Engineering Services

As a high-quality service provider focusing on therapeutic protein production and engineering, CD Formulation is committed to providing advanced protein engineering services to assist you in the modification and optimization of your biotherapeutic lead drug candidates. Our team of experienced scientists and engineers can support the entire process from protein design to expression and purification.

We combine decades of experience in protein engineering with the latest technologies and methodologies to tailor solutions for your project. In addition, we provide protein analysis services for your specific project. We perform a range of routine protein analyses at all project stages to ensure protein identity, purity, structural and conformational integrity, and activity.

Our therapeutic protein engineering services include but are not limited to:

Therapeutic Protein Mutagenesis Services

Our team uses the most advanced DNA synthesis technology to provide efficient polymerase chain reaction (PCR) protein mutagenesis services, as well as comprehensive upstream and downstream services, including template DNA sequencing, gene synthesis, expression vector construction, and protein expression and purification.

Therapeutic Protein Modification and Labeling Services

Protein modification and labeling have been important tools for creating therapeutic proteins and generating novel protein structures, involving adding or changing chemical groups after protein synthesis, or covalently attaching molecules such as biotin, fluorophores, enzymes, and radioisotopes to specific sites of target proteins. We offer a wide range of protein modification and labeling services to meet the research needs of different customers.

Therapeutic Protein Mutation Library Construction Services

Constructing a protein mutation library is a key step to increase protein production, improve function, or study structure-function relationships, which can generate mutant proteins with improved or new properties. With strong expertise in high-throughput gene synthesis and site-directed mutagenesis, we are able to provide a variety of strategies, including gene synthesis, error-prone PCR, degenerate codon utilization, and DNA shuffling, to create your diverse protein mutation library to accelerate your project.

Our Expertise

At CD Formulation, we specialize in custom protein engineering and advanced protein production. With our advanced protein development and production technology platforms, we are able to meet your specific needs. Our protein engineering expertise creates a variety of protein types, including but not limited to:

• Soluble multimeric proteins.
• Targeted proteins for higher target signal and minimal background.
• Recombinant or subunit vaccines.
• Antimicrobial peptides or interferons.
• Recombinant proteins.

Our Downstream Support Services for Therapeutic Protein Engineering

Downstream support services for therapeutic protein engineering include a range of processes and methods designed to refine, purify and characterize proteins with therapeutic applications. These services are critical to ensuring that therapeutic proteins meet the necessary quality, safety and efficacy standards before use in clinical settings or large-scale production.

We offer customizable downstream support services to help you through the entire project lifecycle, ensuring that the protein product is suitable for your downstream application.

Our downstream support 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 Engineering Services?

• We have a team of experienced scientists and engineers with strong biotechnology and protein engineering backgrounds to provide high-quality services to our clients.
• We have successful cases in various therapeutic areas such as antibody therapy, vaccine development, and enzyme replacement therapy, and can provide valuable industry experience and insights.
• We have extensive knowledge to address any complex challenges in therapeutic protein design, optimization, and production.
• We use cutting-edge technologies and tools such as recombinant DNA technology, directed evolution, and computational modeling to create proteins with desired properties.
• We have a complete production process and facilities to efficiently produce large-scale therapeutic proteins to ensure that they meet market needs.
• Our services are highly customizable.

Publication

At CD Formulation, our comprehensive approach encompasses every stage of protein production and engineering, ensuring that your lead drug candidates are optimized for maximum efficacy and safety. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.