Spectrum of Methods

Pick Your Method from Our Large Portfolio

All methods can be applied for development or GMP-compliant testing, depending on your needs.

Method and Application

According to Ph. Eur./USP

Reducing, non-reducing, or native Coomassie, silver, or fluorescence staining or immunodetection for identity or purity testing

Various staining protocols for identity or purity testing, gel-based or capillary based (cIEF)

Determination of purity by CE-SDS for proteins or laser-induced fluorescence detection for pDNA. Determination of residual TFA

Microtiter plate and cuvette based assays such as BCA™, Bradford, and NanoOrange®

Measurement at A280 and A260 for content determination or scanning for characterization

Application with UV, DAD, IR, or light-scattering detection:

Determination of intact mass for proteins (Identification)
Peptid Mapping for verification primary structure
Peptide Mapping for identification modifications (e.g. oxidation, deamidation)

Protein digestion with HPLC separation and UV detection

Application for protein concentration or impurity testing (e.g. process related impurities)

With ethidium bromide or fluorescence staining for DNA and RNA

Enzymatic digestion and agarose gel electrophoresis for identity verification

Fluorescence-based microtiter assays (e.g. PicoGreen®, RiboGreen®)

Phenotypic by API and genotypic by RAPD

For determination of plasmid-retaining cells

Cell-based or ELISA-based assays for determining potency, including statistical evaluation (e.g. proliferation or antiviral assays)

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Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, ANVISA and other regulatory bodies

Analytical development at Richter-Helm BioLogics is set up to establish state-of-the-art, fully compliant solutions for your molecule.

If you have any questions or suggestions, we will be happy to advise you