you wouldn't build a house on un-tested foundations, so why embark on a drug development process before understanding the properties of your lead compound?
At Kuecept, we are highly experienced in physico-chemical and biopharmaceutical profiling of new Active Pharmaceutical Ingredients (APIs); we routinely assist early-stage companies to evaluate the solution and solid-state properties of their lead candidates and use this information to make informed decisions to optimize further preclinical product development.
In addition, these studies aim to highlight potential physical / chemical stability and processing issues that may occur downstream and used at the correct time, can help de-risk development candidates and choose the correct path for formulation development activities.
- Solid-state profiling and determination of critical material attributes (crystallinity, polymorphic form, melting-point / recrystallisation temperature, residual solvent / moisture)
- Hygroscopicity determination and hydrate formation / conversion / stability
- Particle characterisation (size, shape, morphology, surface area, porosity, surface tomography)
- pKa and dissociation equilibrium (experimental and in silico prediction from structure)
- Partition and distribution coefficient as a function of pH (LogP/D)
- pH-solubility profiling
- Solubility determination in biorelevant media (FaSSGF/FeSSGF, FaSSIF/FeSSIF, FaSSCoF, SLF, blood plasma)
- Polymorphic screening and salt selection
- Crystal structure elucidation
|Through our internal capabilities and partner network, Kuecept offers an extensive suite of in silico and in vitro absorption, distribution, metabolism, excretion and toxicity/pharmacokinetic (ADMET) assay solutions:
- CYP450 Inhibition Assay
- Microsomal Metabolic Stability Assay
- Hepatocyte Metabolic Stability Assay
- S9 Metabolic Stability Assay
- Plasma Stability Assay
- Blood Stability Assay
- Plasma Protein Binding Assay
- Blood Partitioning Assay
- MDR1-MDCK Permeability Assay
- Caco-2 Permeability Assay
- Haemolysis (Osmotic Fragility) Assay