Bioassay method development and validation

Bioassay GmbH offers a portfolio of expert GxP bioanalytical validation and testing services focusing on pharmaceutical potency, efficacy and safety. These services can be used to support all phases of drug development.

The Bioassay laboratory teams at Heidelberg have hundreds of years combined experience in conducting regulated bioanalytical assays to test and validate biopharmaceuticals, biosimilars, and vaccines.

Bioassay GmbH is now part of Reaction Biology Corporation, an industry-leading provider of drug discovery and development services.

Laboratory testing and validation services

Bioassay capabilities include proprietary method development, regulatory compliant analytical validation, method transfer, high throughput sample analysis and pharmacokinetic and toxicokinetic assays, combined with automated data capture and reporting systems.

Recognizing the crucial role of bioanalytics in drug development, Bioassay delivers consistently accurate and reliable data that comply with Good Clinical Practice (GCP) guidelines and  can withstand rigorous scientific and regulatory review as the pathway to successful discovery, preclinical and clinical programs.

Bioanalytical testing and validation services cover large and small molecules and include:

• Method development & method validation
• Lead Optimization Studies (efficacy)
• Dose Formulation Analysis (potency)
• Pharmacokinetic (PK) Analysis
• Bioavailability and bioequivalence Studies

Testing capabilities

Bioassay can bring a spectrum of technologies to bear including liquid chromatography (LC), mass spectrometry (MS), capillary electrophoresis and Nuclear Magnetic Resonance (NMR) Spectroscopy. These allow it to carry out:

• Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
• Metals And Elemental Bioanalysis
• Small Molecule Bioanalytical Services
• Rapid Discovery Phase Bioanalysis
• In-vivo and in-vitro bioanalytical assays

Bioanalytical validation and method development standards

All of Bioassay’s bioanalytical studies are conducted  in conformity with Good Laboratory Practice (GLP)  and Good Manufacturing Practice (GMP) guidelines, including rigorous documentation of all biopharma assays, guaranteeing acceptability of validated data generated for product acceptance and licensing.

GMP and GLP guidelines also form the basis for Bioassay’s own quality and reliability standards that serve to encourage continuous improvement and reinforce transparency backed up by regular customer audits and periodic inspection by leading regulatory authorities.