Evotec has a breadth of experience in regulated bioanalysis for small molecules and bio-therapeutics of any size: peptides, recombinant proteins, monoclonal antibodies, oligonucleotides, as well as anti-drug antibodies, vaccines, cell therapies and gene therapies, for non-clinical and clinical sample analysis.
The Bioanalytical group includes also clinical pathology laboratory activities in order to support pre-clinical studies.
Bioanalytical validations are performed according to EMA/FDA guidelines and the analyses are performed in compliance with GLP or GCP regulations.
Our bioanalytical laboratories in Verona are GLP accredited by the Italian Ministry of Health and are authorized by AIFA (Italian Drug Agency) to perform analysis supporting clinical trials, including Phase I studies in healthy volunteers and patients.
The scientific experience, integrated services, capacity and application of the state-of-the-art bioanalytical equipment provide fast turnaround that will help to arrive at “go/no-go” decisions faster.
The bioanalytical capabilities can serve also as part of an INDiGO programme, Evotec’s solution designed to de-risk and accelerate IND-enabling programmes.
The bioanalytical facility offers the capability to store up to 280,000 biological samples in dedicated -20 and -80ºC freezers connected with a validated temperature monitoring system.
