Therapeutic Developability Assessment

As the increasing challenges including lower approval rates, escalating costs of novel therapeutic products, screening of potential candidates in early discovery stages can help reduce costs, potential risks and overall R&D time. To help our clients achieve this goal, Creative Biolabs is dedicated to therapeutic developability assessment to help you survive in the drug discovery and development, and de-risk your pipeline.

To evaluate the manufacturability, physicochemical properties, and safety profiles of the promising drug-like candidates, developability assessment is established which is important for the success of a viable drug. During developability assessment, the candidate should have consistent manufacturability, low product heterogeneity, and stability to ensure high yields and quality. Developability assessment is becoming an increasingly critical criterion to mitigate the potential risk (see Fig.1).

At Creative Biolabs, we have established developability assessment in the discovery and engineering phases to screen antibody, and accelerate the candidate selection process. The analysis results we provided can significantly reduce the cost and time of downstream manufacturing.

Fig.1 The importance of developability assays in early stages.

Creative Biolabs has established a comprehensive platform for a series of fast and small-scale tests, and also in silico predictive tools which can be employed to serve as another criteria. We aim to select the better and safer therapeutic leads for you. Here is a quick check for our services.

• CE-SDS (reducing and non-reducing), SE-HPLC, cIEF
• DSF/DLS, PTM analysis
• Octet (FcRn and Fc-gamma R binding profile)
• Sequence liability analysis
• Poly-specificity analysis
• Hydrophobicity assessment, forced degradation study

We are capable of analyzing chemical degradation pathways, post translational modifications and potential stability issues such as protein aggregation. For various protein types derived from mammalian or microbial expression system, this kind of service is available.

• Potential hot spots for degradation and post-translational modification analysis;
• Conformational, thermal stability and colloidal study via high-throughput methods including micro-DSC, DLS, and CD etc.;
• Stability test in different conditions;
• High concentration protein developability assessment.

We developed a wide range of physicochemical property assessments to help select the best candidate with the most stable characteristics including, but not limited to:

In addition, we also provide other assessments including chemical modification assessment, and in vivo properties assessment.

• Chemical modification assessment: we offer various evaluations including isomerization, oxidation, deamidation, as well as succinimide formation etc. To assess in vivo and in vitro binding behaviors.
• In vivo properties assessment: we offer in vivo half-life characterization studies via serum stability/PK studies in rodent and cynomolgus monkeys.

After program is completed, the final assessment report will be delivered to customers with full data highlighting the predictions and analyses. If potential high-risk issues are identified in the final report, our experts are committed to improve the structure, biological activity and the manufacturing properties of your candidate products. Extensive range of protein engineering capabilities will enable us to achieve this goal.

• Reduce development costs and time
• Accelerate the lead candidate optimization process
• Increase the chance of a successful candidate
• De-risk your pipeline before problems arise in development process
• Improve the chance of successful manufacturing scale-up

Creative Biolabs is always dedicated to be your best trusted partner in therapeutic protein product discovery and engineering. Please contact us for more details and quotes.

For Research Use Only | Not For Clinical Use