Clinical Trials and Development Services
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Germany

BioAssay – Pharmaceutical Specialists

Pharmaceutical Specialists

BioAssay – Pharmaceutical Specialists

Bioassay is a bioanalytical contract laboratory located in Heidelberg (Germany) with focus on the development, validation and routine analysis of in-vivo and in-vitro bioassays. Bioassay offers the execution and assessment of potency assays within quality control of active pharmaceutical ingredients and drug products as well as in the phase of drug discovery and development. We aim to be one of the number one Pharmaceutical Specialists.

We have extended experience in the development and validation of new assays accordingly to ICH-Guidelines as well as in optimization of existing assay formats and transference into routine applications. Our lab is GLP and GMP certified and successfully inspected by the FDA and standard assays are established for various hormones, therapeutic antibodies and growth factors.

Bioassay offers also a panel of assays for safety and functional assessment of monoclonal antibodies to any kind of recombinant proteins to characterize biotherapeutics in this respect.

Key global players as well as start-up companies in the pharmaceutical and chemical industries trust in the experience and dedication of our bioanalytical experts – this is why we are one of the top Pharmaceutical Specialists.

GMP Potency Assays

Bioassay GmbH offers the execution and assessment of potency assays within quality control of active pharmaceutical ingredients and drug products. Further we have extended experience in the development and validation of new assays accordingly to ICH-Guidelines as well as in optimization of existing assay formats and transference into routine applications.

Established potency assays of therapeutic antibodies and antibody-drug conjugates (ADC) are running under GMP at Bioassay GmbH. Further, the development of assays regarding Antibody Dependent Cell mediated Cytotoxicity (ADCC) attributed to the mode of action of therapeutic antibodies, in particular tumor cell targeting, is one our focus areas. Bioassay GmbH is offering ADCC assays for development and quality control for the biopharmaceutical industry.

Hormones and growth factors are widely used within the biopharmaceutical industry. Our portfolio include most of them and potency assays based on monographs of EP and USP are running under GMP in a daily quality control routine for stability testing and batch release of active pharmaceutical ingredients and drug products. Our portfolio includes Erythropoietin, Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), Human Chorionic Gonadotropin (HCG), Parathyroid Hormone (PTH), Filgrastim (G-CSF), Human Growth Hormone (hGH) & Interleukins.

Functional Bioassays – Pharmaceutical Specialists

Bioassay GmbH has established efficacy models to address the demand of characterization of new drugs, especially in the field of biopharmaceuticals like monoclonal Antibodies, Hormones or Cytokines, including FACS-Based Receptor Binding Assays or Bio-Layer Interferometry (BLI) and specific cell line development or neutralizing antibodies assays. All of these developments help us become Pharmaceutical Specialists. Bioassay GmbH has extended experience in the field of characterization of Biosimilars or modified Biologics (e.g. pegylated products).

Peptide Specific Services

Bioassay GmbH and its partner Peptide Specialty Laboratories GmbH (P.S.L.) offering customized services regarding the production, modification, labelling and characterization of peptides.

Further, Bioassay and PSL offer a customized peptide specific antisera service. We have achieved a high success rate in the generation of specific antisera through using high quality for the preparation of our antisera.

In-Vivo Pharmacokinetic & Disease Models

Bioassay offers basic pharmacokinetic & metabolic studies in different species. Further, specific nephrology & diabetic models have been established and can be combined with our analytical services for extended and customized range of biomarkers. In detail these models are established at Bioassay:

  • Acute Kidney Injury (AKI) / Ischemia-Reperfusion-Injury (IRI)
  • Kidney transplantation model
  • 5/6 Nephrectomy (Chronic Kidney Disease)
  • Hypertension Model (e.g. renal artery stenosis)
  • Unilateral Ureteral Obstruction (UUO)
  • Diabetic nephropathy
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