Vela offers GMP-compliant protein characterization applying a state-of- the-art analytical portfolio. Analysis is performed by highly qualified and trained staff based on a sound scientific rationale and in accordance with the relevant guidelines (ICH, EMEA).
By offering a structured, clearly laid out ‘method flow’ approach that reflects the various stages of drug development, each customer can be served exactly to their needs. Based on our experience with regulatory agencies and customers, we recommend the following ‘method status’:
> Preclinical testing: developed
> Toxicity Study / Clinical Phase I: qualified
> Clinical Phase II and III: validated
