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PharmaGMP Testing – GBA Pharma LabsProteincharakterisierung

Protein characterization

GBA Pharma Labs Protein characterization Exemplary comparison of different glycan structures analyzed by fluorescence detection

Analytic of proteinogenic drugs

Characterization of proteinogenic drugs is an essential aspect of quality control of new biopharmaceuticals, starting from development up to production of approved drugs. The pharmacopoeias allow a wide range of methods for this purpose, primarily using HPLC/UPLC-based methods with different detectors such as UV/Vis, fluorescence or mass spectrometric detectors.

GBA Pharma Labs offers a wide range of methods based on the latest HPLC/UPLC systems with various detection systems, as well as capillary electrophoresis. For mass spectrometric characterizations, the Orbitrap Exploris system from ThermoFisher Scientific is available qualified under GMP conditions.

The following parameters can be analyzed at our laboratories:

  • Peptide mapping
  • Amino acid sequence determination
  • High-resolution mass determination of proteins and peptides
  • Qualitative and quantitative determination of posttranslational modifications such as oxidation methionine
  • Qualitative and quantitative analysis of glycans
  • Determination of aggregates
  • Determination of charge variants

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs – GMP Testing

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GMP Quality Control

Method Development & Validation

Stability Studies

Dissolution

Extractables & Leachables

Packaging Material Testing

Particle Determination

Elemental Impurities Testing

Microbiology

Regulatory Services

Amino Acid Analysis

Instrumentation

GBA Pharma Labs Trace-level analytic for N-nitrosamines

N-nitrosamines

GBA Pharma Labs qPCR

qPCR

GBA Pharma Labs iCEF

cIEF

GBA Pharma Labs Protein characterization

Protein Characterization

GMP Testing

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