Bioassay bioanalytical validation and analytical testing services

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

The Bioassay laboratory teams at Heidelberg have long lasting experience in conducting regulated bioanalytical assays to test and validate biopharmaceuticals, biosimilars, and vaccines.

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 seeks to deliver consistently accurate and reliable data that comply with Good Laboratory and Manufacturing Practice (GLP & GMP) 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:

Pharmacokinetic (PK) Analysis

Bioavailability and bioequivalence Studies

Method development & method validation

Lead Optimization Studies (Mode of Action studies and potency assays)

Testing capabilities

Bioassay can bring a spectrum of technologies to bear including liquid chromatography (HPLC), mass spectrometry (MS), Flow Cytometry and Bio-Layer Interferometry  Bioanalytical validation

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.