Method development

  • 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:

Let’s take a look at a typical flow for liquid chromatographic (LC) method development.

Method Screening

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.

Method Optimization

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.