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Bioassay laboratory services
Bioassay GmbH possesses the expertise and facilities required to provide a wide range of bioanalytical laboratory services, including assays, testing, validation and analysis.
This Heidelberg-based independent contract analytics laboratory specializes in the development, validation and routine performance of bioanalytical assays in the area of Pharmacology and Toxicology.
It carries out qualified analytics lab services soundly based on GMP & GLP certification, providing a reliable framework for successful projects and routine bioanalysis.
Bioanalytical laboratory services
Key global players as well as start-up companies in the pharmaceutical and chemical industries trust in the experience and dedication of Bioassay’s team of bioanalytical experts, who are specialists developing, validating and executing biological assays within the framework of Development & Quality Control of pharmaceutical and chemical products.
Bioanalytical services are based on Bioassay’s four focus areas of core competency:
- BioPharma Potency: Execution and assessment of potency assays within quality control of active pharmaceutical ingredients and drug products, along with development and validation of new assays conforming to ICH-Guidelines as well as optimization of existing assay formats and transference into routine applications. Bioassay lists a wide range of established potency assays for antibodies, hormones, growth factors and cytokines.
- BioPharma Efficacy: Established efficacy models addressing demand for characterization of new drugs, especially in fields such as monoclonal antibodies, hormones or cytokines. Bioassay can characterize efficacy of biosimilars or modified biologics, such as pegylated products, and can also provide specialized characterization models for drug candidates in the fields of nephrology and diabetes. Efficacy assays can be executed as Cell-based Analysis (e.g., FACS-based Receptor Binding Assays or specific cell line development) or Pharmacokinetic & Disease Models (e.g., pharmacokinetic & metabolic studies, specific Nephrology & Diabetic models, etc.).
- BioPharma Safety: Bioassay offers a panel of assays for assessment of monoclonal antibodies to any kind of recombinant proteins to characterize biotherapeutic interactions with many different molecules in the human body to check for unwanted effects that might result in an unacceptable safety profile or compromise therapeutic efficacy of a compound. Safety assays cover biologics such as Antibody-dependent cellular cytotoxicity (ADCC), neutralizing antibodies, Multi-Cytokine Analysis, Immunotoxicology, Skin Sensitization assays and Toxicokinetics.
- Chemicals / Cosmetics Safety: Acute toxicity and skin sensitization studies under GLP for the chemical and cosmetic industry, providing standardized assay methods for chemical and cosmetic products safety in respect of a wide range of Organisation for Economic Co-operation and Development (OECD) guidelines covering conditions such as dermal toxicity, dermal Irritation, eye Irritation and oral toxicity. Bioassay 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 sensitization testing to be used by chemical and cosmetic industries for the safety assessment of products.
Analytic laboratory facilities
Bioassay’s analytics laboratory is located at the Heidelberg Technology Park in southern Germany. The laboratory has more than 1,500 m2 of floor space, accommodating state of the art in-vivo and in-vitro facilities and leading-edge equipment.
Regular upgrading of staff qualifications and testing systems are both for the validity of processes. For this reason, Bioassay places particular emphasis on in-house and external training of its employees.
Quality must be verifiable and therefore Bioassay bioanalytical laboratories undergo regular inspections by regulatory authorities and customer audits, in addition to the company’s own QA audits.
The standard and qualification of Bioassay bioanalytical lab capabilities and facilities are further confirmed by the company’s successful participation in various international collaboration studies.