Comparability Studies
Avacta can provide a suite of comparability analysis to enable batch to batch characterisation for the confirmation of batch consistency or indeed the early identification of key attributes and the selection of initial process and/or product specifications.
Formulation Studies
Avacta can perform accelerated stability studies in line with the recommendations of the ICH guidelines Q1A(R2) or tailored to a customer’s specific needs for APIs, Drug Substance and Drug Product.
Protein Characterisation
Avacta can provide a suite of analysis designed to present characterisation data from early pre-clinical through to support for Phase III and marketing.
Stability Testing
Avacta can provide a suite of stability analysis to enable early selection of candidates, identify key degradation routes and support for selection of downstream purification in manufacture.
