Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

Complex characterization projects for innovative biologics and comparison of biosimilars.

Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.

Determination of active enzymes and enzymatic biomarkers in biological and formulation samples according to GLP.

Testing lab for biosimilar products – GMP inspected by U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Full ICH studies and on-going stability programmes at different storage conditions.

GMP-certified characterization and definition of quality attributes of Adeno-associated virus (AAV), Adenovirus (AV), and Lentivirus (LT).

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vaccines and other biologics.

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

Biomarker analysis services across various therapeutic areas aided by our state-of-the-art equipment and multiplexing techniques.

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.

GMP-certified OINDPs testing for a broad range of delivery services including inhalers, nebulizers and nasal.

GLP-certified histopathology evaluation and consultancy services through our strategic partner Patconsult in order to complement our preclinical bioanalytical offer.