Bioassay GmbH is specialized in the development , validation and execution of biological assays within the framework of Development & Quality Control of pharmaceutical and chemical products.
Our portfolio contains 4 focus areas:
- BioPharma Potency
- BioPharma Efficacy
- BioPharma Safety
- Chemicals / Cosmetics Safety
In our in-vivo and in-vitro facilities with more than 1000 m2 we are running state-of-the-art-equipment and our analytical experts will welcome you to visit us in our laboratories located directly in the Heidelberg Technology Park (Germany).
Please click into the indicated service areas of the graph to get detailed information.
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 running under GMP at Bioassay GmbH are listed as follows:
- Antibody Dependent Cellular Cytotoxicity (ADCC)
- Complement Dependent Cytotoxicity (CDC)
- FACS-Based Binding Assays
- Follicle Stimulating Hormone (FSH)
- Luteinising Hormone (LH)
- Human Chorionic Gonadotropin (HCG)
- Parathyroid Hormone (PTH)
Growth Factors & Cytokines
- Filgrastim (G-CSF)
- Human Growth Hormone (hGH)
Further assay formats already exist or can be developed at short notice
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. Bioassay GmbH has extended experience in the field of characterization of Biosimilars or modified Biologics (e.g. pegylated products).
Further we provide specialized models for characterization of drug candidates in the field of nephrology and diabetes.
Cell based Analysis
FACS-Based Receptor Binding Assays
Specific Cell Line Development
Pharmacokinetic & Disease Models
Pharmacokinetic & Metabolic studies
Specific Nephrology & Diabetic Models
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)
Complex biotherapeutics interact with many different molecules in the human body to develop their mode of action. This increases the possibility of unwanted effects which might result in an unacceptable safety profile or compromise therapeutic efficacy of a compound. Bioassay offers a panel of assays for assessment of monoclonal antibodies to any kind of recombinant proteins to characterize biotherapeutics in this respect.
Antibody-dependent cellular cytotoxicity (ADCC)
Skin Sensitization assays (LLNA, h-Clat & MUSST)
Testing acc. to Pharm.Eur. 2.6.14
Turbidimetric & chromogenic
Chemicals / Cosmetics Safety
Bioassay GmbH is running acute toxicity and skin sensitization studies under GLP for the chemical and cosmetic industry.
Bioassay GmbH was recently chosen by the European Commission Joint Research Centre to participate in a project whose aim is to deliver validated alternative methods/strategies for skin sensitisation testing to be used by chemical and cosmetic industries for the safety assessment of products. We worked in close contact with multinational companies as well as the European Commission Joint Research Centre for the initial assessment of two of those tests involving flow-cytometry methods.
Standardized assay methods for chemical and cosmetic products safety are provided for
OECD 402 (Dermal toxicity)
OECD 404 (Dermal Irritation)
OECD 405 (Eye Irritation)
OECD 423 (Oral toxicity)
Toxicity-Prediction (BALB/c 3T3 Neutral Red Uptake Cytotoxicity Test)
OECD 442B (Chemicals)
H-Clat Assay (Cosmetics)
MUSST Assay (Cosmetics)
OECD 406 (Chemicals)