Assay Development & Consulting
Assay Development
Sometimes new chemical entities require novel approaches to ADME and PK in drug development. To overcome slow development and optimization of new assay systems, we have developed a simulation engine for laboratory test systems that radically cuts down development time by simulating the majority of lab experiments needed for validation. We have collaborated with several major pharmaceutical firms to optimize laboratory approaches. For instance, we have introduced quality control measures in assays that replace manual data quality control by automatic analysis. We have developed entirely novel test systems for optimizing peptide half-life and developed custom test kits for difficult amphoteric structures with strong non-specific binding properties.
Once a viable assay system or kit is developed, we either mass produce it for our clients, or facilitate in-house production at our client’s sites.
Consulting & Scientific Advisory
The ready-to-use TRANSIL assay kits for plasma protein binding, membrane binding and permeability don’t require expert knowledge and can be operated by general lab technicians. Some small pharma and biotech organizations lack the domain knowledge to plan experiments, make the most use of the test kits and relate results to project objectives. Other firms used to outsource those experiments and now have a less expensive means to bring them back. We support our clients in writing internal reports and communicating with regulatory authorities, so they can maintain their flexibility by not increasing the expert level staff headcount.
Our areas of expertise cover:
A) Plasma Protein Binding
- Strong plasma binders
- Binding to individual plasma proteins and PBPK modelling under disease conditions
- Displacement
- Blood-plasma partitioning
- Assay system selection
- Regulatory review and guidance
- Reports and responses to regulatory authorities
B) Membrane Interactions
- Tissue distribution
- Volume of distribution
- Intestinal absorption
- Intestinal absorption
- Brain penetration and brain tissue binding
- Blood vessel binding