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Tailor-made bioassays for pharmaceuticals

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Method development, validation, release and stability tests


Bioassays for biopharmaceuticals


In vitro bioassays are of particular importance for the development of biopharmaceutical drugs. Bioassays, "Mode of action Assays", are used, for example, to test the efficacy of a therapeutic antibody.

Eurofins BioPharma Product Testing Munich has many years of scientific and experimental know-how in developing and validating tailor-made cell-based bioassays and binding assays. Furthermore, in close cooperation with our preferred partner laboratory BSL BIOSERVICE Munich in vivo bioassays can be performed.

 

Substance Class

Type of Assay

Assay Readouts

Therapeutic Antibodies

 

Cell Proliferation, Cell Survival, Cell Apoptosis, Reporter Gene Assay, Binding Assay, Cellular Binding Assay, Cell Migration Assay, ADCC

Absorbance, Luminescence, FACS, ELISA, SPR 

Bispecific Therapeutic Antibodies Cell Proliferation, Reporter Gene Assay, ADCC Luminescence, TRF
Antibody Drug Conjugates/Immunoconjugates Cell Survival, Binding Assay Luminescence, ELISA 
Hormones/Cytokines Cell Proliferation, Viral CPE Assay, in vivo Assay Absorbance, Luminescence, FACS, ³H Thymidine Incorporation
Peptides Reporter Gene Assay Luminescence
Viral Particles / Viral Like Particles in vivo Assay  ELISA
Soluble Receptors Cellular Binding Assay, Binding Assay FACS, ELISA

 

Our team of experts carries out GMP testing of around 1,200 batches per year for the EU and US markets.

 

Applied methods and guidelines

In addition to various customer-specific assays, the methods required in the pharmacopoeias for erythropoietin (EPO), (PEG) - filgrastim / filgrastim (G-CSF), urofollitropin (FSH), interferon-alpha, interferon beta and insulin are currently offered.

The development, optimization (Design of Experiments, DOE), validation and execution of the bioassays are carried out according to GMP guidelines and have been inspected several times by the FDA. Our validation strategies are based on the requirements of the respective sponsor and are based on international regulatory guidelines and recommendations such as ICH, US-FDA, ISO, EMA, USP / EP.

In addition to various validated and customized assays, we have developed and implemented different methods for biosimilar characterization:

  • Golimumab, Etanercept, Adalimumab, Bevacizumab, Rituximab, Trastuzumab
  • Interferon, Erythropoietin, (Peg-)Filgrastim, Somatropin


Through our close cooperation with Eurofins Lancaster in the USA, we provide our customers with worldwide capacity and full expertise.