TIDES (Oligo & Peptides)

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

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

Complex characterization projects for innovative biologics and comparison of biosimilars.

Development and validation of analytical methods for analysis of biological samples delivered mainly from pre-clinical and clinical studies.

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

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

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

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

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

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

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

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

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

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