Therapeutic Developability Analysis
Assessing the developability of a therapeutic candidate helps to select the candidate with the most stable profile and to avoid potential problems in later development. In general, therapeutic developability assessment refers to the evaluation of the drug-like properties, manufacturability, and safety of a potential pharmaceutical candidate, and it often includes the assessment of the biophysical and chemical properties of the drug candidate. Establishing a reliable therapeutic developability assessment is important for the success of a viable drug, and therefore the therapeutic developability assessment is becoming an increasingly critical criterion. BOC Sciences has introduced a range of in silico predictive tools and rapid, small-scale assessments as additional criteria for the selection of better and safer therapeutic leads. Our scientists are committed to providing the final drug candidates with consistent manufacturability, low product heterogeneity and stability, ensuring high yield and quality.
Application of Therapeutic Developability Analysis
- Minimize the risk of late-stage failure
- Provide safer drugs for patients
- Improve the chance of successful manufacturing scale-up
- Increase the chance of a successful candidate
- Accelerate the lead candidate optimization process
Figure 1. Developability assessments.(Schmidt, S. R. 2017)
Our Services
To make it easier and better for researchers, BOC Sciences provides therapeutic developability analysis service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
Therapeutic developability assessment solutions
- CE-SDS (reductive and non-reductive), SE-HPLC, cIEF
- DSF/DLS, PTM analysis
- Octet
- Sequence responsibility analysis
- Multi-specificity analysis
- Hydrophobicity assessment, forced degradation studies
Manufacturability assessment
Our team analyzes chemical degradation pathways, post-translational modifications and potential stability issues, such as protein aggregation
- Potential hotspots for degradation and post-translational modification analysis
- Conformational, thermal stability and colloidal studies via high throughput methods
- Stability testing under different conditions
- High concentration protein exploitability assessment
Figure 2. Potential sources of failures during development. (Schmidt, S. R. 2017)
Property assessment
- Chemical modification assessment: isomerization, oxidation, deamidation, and succinimide formation, etc
- In vivo characterization: We offer in vivo half-life characterization studies
- In vitro potency testing
In silico analysis
- Heavy and light chain variable region liability analysis
- VH and VL analysis to identify core residues with potential affinity to MHC class II
Integrity assessment and formulation studies of drug candidates
- Multi-specificity and integrity assessment
- Formulation studies under accelerated stress conditions
Robust bioanalytical assays and formulation studies
- Various bioanalytical assays and characterization tools
- A small amount of materials are needed for the bioanalytical assays and formulation studies
Figure 3. Ranking matrix for developability assessment. (Schmidt, S. R. 2017)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of therapeutic developability analysis at competitive prices for global customers. Personalized and customized services of therapeutic developability Analysis can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Schmidt, S. R. Strategies to Predict the Developability of Biopharmaceuticals. American Pharmaceutical Review. 2017. 20(6): 122-125.
