Quality by design approach
Fit for purpose
Guarantee of validation
Are you cost, quality and time sensitive? You will certainly recognize this scenario: you spend more than a month varying all parameters of a method. During transfer to another lab, you discover that the method was not robust and system suitability parameters can not be met.
Anabiotec is specialist in the development of analytical methods for the determination and identification of all compounds related to drug substances or drug products:
- assay determination and identification of the main compound
- purity determination of related substances
- genotoxic quantification
- chiral purity determination
- water content detection
- dissolution methods
- particle size determination
- residual solvent determination
Let’s take a look at a typical flow for liquid chromatographic (LC) method development.
We develop liquid chromatographic methods using a quality by design software package, taking your requirements into account: for example high resolution, short analytical runtime, number of separated impurities. All methods are fit for purpose and meet minimal criteria to avoid costs and delays in later phases.
We optimize the analytical methods when the drug product moves into later phases. This optimization is performed according to the purposes defined at each respective stage.
Don’t you dream of one analytical method, suitable for your drug substance and all drug product formulations? We develop them using quality by design!
Furthermore, we guarantee that we can validate these methods, as appropriate, at each stage of the drug development process.