Therapeutic Developability Analysis
As the early evaluation of the monoclonal antibody lead candidate antibody can avoid delays in the later development process, the development evaluation has received more and more attention. The concept of developability is based on the knowledge gained from the successful development of approximately 80 marketed antibody and Fc fusion protein drug products, as well as the lessons learned from many failed development programs in the past 30 years. Without extensive characterization to understand the biochemical and biophysical properties of selected candidates, unexpected modifications, stability, or poor PK and PD may cause the project to delay or even terminate. The development risk is often related to the intrinsic properties of the candidate drug. Therefore, it is very important to conduct a developability assessment before entering the process development. Developability evaluation is a process used to systematically evaluate candidate drugs, including structure evaluation and safety, PK and PD, and manufacturability, etc.
Early evaluation of the developability of candidate therapeutic drugs can help avoid potential problems in later development. These evaluations include the evaluation of the biophysical and chemical properties of the candidate drug. At CD BioSciences, we provide you with the following therapeutic developability analysis services according to your specific needs:
- N-glycosylation site and cysteine in Fv domain
Fv glycosylation may affect target binding and may have an impact on biodistribution or pharmacokinetics. The additional N-glycosylation sites in the Fv domain can also lead to product heterogeneity, which may pose a considerable challenge to the production of therapeutic antibodies with a consistent glycoform profile.
- Degradation of asparagine and aspartic acid in Fv domain
The deamidation of asparagine, the isomerization of aspartic acid residues, and the formation of common cyclic succinimide intermediates are the most common degradation reactions in the body after production, storage or administration of therapeutic proteins. Therefore, CD BioSciences provides degradation analysis services of asparagine and aspartic acid in the Fv domain.
- Lysine glycosylation
The glycosylation of lysine residues, that is, the non-enzymatic reaction between the amine group of lysine and reducing sugars such as glucose or fructose, is another source of product heterogeneity. Therefore, CD BioSciences provides lysine glycosylation analysis services.
- Apparent hydrophobicity
Hydrophobicity affects the aggregation, solubility and viscosity of monoclonal antibodies. Therefore, CD BioSciences provides apparent hydrophobicity analysis services.
Solubility is an important development parameter for antibodies, especially considering the need for higher concentration formulations (above 100 mg/mL). CD BioSciences provides solubility analysis services.
- Thermal stability
Adequate thermal stability is believed to be important for long-term reduction of aggregation. Therapeutic antibodies often need to have high thermal stability.
Immunogenicity is still a worrying issue, even for monoclonal antibodies with full human sequences. CD BioSciences uses a variety of tools, including electronic calculations, in vitro analysis or in vivo animal models, to identify amino acid sequences that cause immunogenicity.
✓ The CD BioSciences team has extensive knowledge and experience in antibodies. We work with many scientists from many pharmaceutical and biotechnology companies and organizations.
✓ CD BioSciences will complete your project efficiently and on time, and meet your requirements.
✓ CD BioSciences has professional after-sales service: a professional after-sales service team has been established to provide customers with efficient, fast, practical and feasible solutions.
Our Service Items
|Project name||Therapeutic developability analysis|
CD BioSciences offers therapeutic developability analysis services to meet the specific needs of different customers.
Antibody heavy and light chain sequences.
|Product delivery mode||
We will complete the project on time according to the agreed time.
1 to 2 weeks
Why choose us?
The developability evaluation has been identified as a critical step and should be evaluated in the early stages of selecting drug candidates for development. Because it can reduce the time and development cost required to deal with the challenges caused by antibody drug candidates with poor physical and chemical properties. Establishing a developability evaluation and conducting experimental design on this basis is an indispensable step in the process of screening the best and ideal drug candidates from a large number of drug candidates. CD BioSciences provides professional therapeutic developability analysis to meet the needs of regular customers to determine hits on time and on budget. Please feel free to contact us for more detailed information, our scientists will tailor the most reasonable plan for your project.