More than 20 years of experience
Supporting selection for Clinical and Commercial Success
Data science based liability site identification
Developability assessment is a pivotal process in drug development. This multifaceted evaluation of potential therapeutic candidates’ drug-like properties, manufacturability, and safety profile is crucial during the pre-clinical stage for clinical and commercial success. By identifying the most stable candidate early on, the risks of costly late-stage failures are minimized, benefiting both the industry and patients.
Selecting a drug candidate for clinical and commercial success is a critical step in the drug development process. Early-stage Developability Assessment expedites the process by identifying the best lead candidates, identify potential development challenges, identify risks like aggregation, fragmentation, and suboptimal solubility, and reduce the risk of attrition. It ensures that molecules with suboptimal properties don't progress directly to late-stage development, decreasing failures, lowering costs, and shortening development timelines.
Developability assessment extends the Quality by Design concept, encompassing a thorough investigation into the manufacturing feasibility, ideal administration route, and in vivo compatibility. By evaluating expression, stability, solubility, and purity, among other critical parameters, this assessment ensures a favorable biological drug profile, conserving resources and preventing late-stage setbacks.
Leuukocare’s Developability Assessment Expertise
Leukocare's scientific expertise can help to de-risk your drug development. As it is important to assess the developability of your drug candidates, starting with the design of the developability assessments to the intended commercial use and ending with the selection of the best candidate, Leukocare’s scientific project leaders work with you on the establishment of the developability assessment and its methods. As the Target Product Profile (TPP) often changes between early and late/commercial phases, it is also important to address, the further developability of candidates. Leukocare offers a range of services and analytical methods to assess these CMC properties that may affect the formulability, manufacturability and administrability of the drug candidate. From biophysical methods and the interpretation of their data to the use of data-science and Molecular Modeling, our team is committed to helping you find the best lead candidate for your clinical and commercial success.
Services for Developability Assessment
Characterization
In-silico Characterization – Molecular Modeling
Biophysical Characterization
Molecular Purity and Integrity Analysis
Formulability
TPP fit
Osmolality, pH, and viscosity analysis
Concentration Studies
Molecular Purity and Integrity Analysis
Manufacturability
Adsorption Studies
Spiking Studies
pH Jump Studies
Manufacturing Stress Studies
Administrability
pH Jump Studies
In-use Stability
