Peptide mapping using reversed-phase high performance liquid chromatography (RP-HPLC): Peptide mapping is a technique for identifying and analyzing the structure of proteins. A protein in the sample is enzymatically digested and the resulting peptides are separated and analyzed using reversed-phase chromatography (RP-HPLC). The separation of the peptides produces a peak profile that is characteristic of the sample, a so called “fingerprint profile”. This “fingerprint profile” is then compared with the corresponding reference material, which has been treated in the same way as the sample to be tested.

Cation exchange HPLC using photometric detection (CEX-UV) enables the separation of samples into different isoforms as well as degradation products and impurities. The separation of the molecule is based on electrostatic interactions between the molecule and the ion exchange material of the column.

Capillary electrophoresis (CE) is a technique in which molecules are separated in an electric filed based on differences in their charge and size. An electric field is applied to a capillary where both ends of the capillary are immersed in a suitable buffer. The buffer allows negatively charged molecules to migrate to the anode at different velocities depending on their molecular weight. As the molecules pass through the capillary, they are detected by measuring the UV absorption at a specific wavelength.

Non-ionic surfactants such as polysorbate 20 and polysorbate 80 are often used as stabilizing excipients in biopharmaceuticals. We use high-pressure liquid chromatography (HPLC) in combination with the Charged Aerosol Detector (CAD) to quantify polysorbates.

Visual and functional tests on primary packaging materials and application systems.

Force measurements to determine the ejection forces of prefilled syringes, cartridges, needle shield applicators and autoinjectors as well as measurements of the force required to bridge the locking of the needle shield (breakout or break loose force, glide force, needle shield protection force).

Enzyme-linked immunosorbent assay (ELISA) is a plate-based assay that detects certain molecules (antigens or antibodies) with an enzymatic color reaction. Various ELISA test types can be used: Direct ELISA, sandwich ELISA, or competitive ELISA.

We are also happy to support you in testing oral drug products in biorelevant media. This simple in vitro method helps you to evaluate the formulation-dependent release of active ingredients over time, especially for poorly soluble drugs.

We offer innovative approaches, experienced teams, and suitable analytical methods for all requirements.