For ideal process understanding and control we provide development of HPLC based analytical methods.
To deliver best results for our customers, we start with thorough sample characterization. In cases purified target molecule (standard) is already available; the analytical method development is facilitated, leading to shorter delivery times.
Analytical Method Development comprises the following services:
1. Sample characterization:
- Determination of protein and DNA concentrations;
- Impurity profile on SDS-PAGE or SEC column;
- Agarose gel electrophoresis.
2. Method development:
- Screening of available CIMac™ chemistries;
- Optimization of analytical method, including the testing of different chromatographic modes and optimization of buffers for achieving optimal resolution and selectivity (as defined by the customer);
- Comparison with existing chromatographic method (if available);
- Determination of LOQ, LOD and linearity of the developed analytical method;
- Validation of the developed analytical method.
3. Laboratory Services for biomolecules and small molecules/ pharmaceutical samples:
- Analytical method development, validation and verification, transfer and routine testing