Select the optimal lead molecule
The aim of formulatability studies is to identify molecular liabilities, in conjunction with in silico modeling, that can negatively affect drug product stability or quality during the drug product’s lifetime, from manufacturing to administration to the patient. This information can be extremely valuable for selecting the optimal lead molecule from among a panel of potential molecule candidates or variants. It is also essential for selecting the appropriate drug product development strategy, including tailoring formulation development studies to address the molecule’s specific shortcomings, thus ensuring its clinical and commercial success. Our experts have extensive experience in identifying potential development risks, and provide means to mitigate those risks.
Assessment of chemical liabilities
We support the evaluation of chemical-degradation endpoints, including oxidation, deamidation, clipping, and glycation. We perform forced degradation and stress studies, including thermal, pH, light and other stress conditions, to assess the impact of degradation on the mode of action such as binding. This enables us to evaluate the criticality of a degradation route (CQA assessment).
Biophysical characterization, colloidal and conformational stability
We measure conformational stability using a panel of relevant endpoints, including melting temperature fluorescence and/or evaluation of higher order structure, e.g. by circular dichroism (CD) and/or fourier-transform infrared spectroscopy (FTIR).
Viscosity and rheological properties
Viscosity and rheological properties can impact manufacturability and injectability (administration), especially when administration volumes are somewhat limited, such as for subcutaneous or intravitreal use.
Our locations
Location where this service is provided
Basel, Stücki Technology Park, Switzerland
The Drug Product Services (DPS) group is located in Basel, Switzerland with state-of-the-art analytical, formulation and drug product processing equipment, and unparalleled expertise in parenteral drug product development, manufacturing and testing.
The DPS team is highly experienced in the development, manufacture and analysis of parenteral formulations and finished drug products for injection, infusion or implant of a variety of product types and molecules. The drug product analytical development and quality control group has industry-leading technical, scientific and regulatory expertise in method development, product characterization and testing of biopharmaceuticals and parenteral small molecule formulations.