Quality By Design
AET BioTech considers quality, efficiacy and safety as the most important characteristics of a biosimilar product.
Consequently, AET BioTech incorporates requirements of current and anticipated guidelines from the WHO, EMA and FDA as well as national regulatory agencies into the development of its biosimilar products, and works with partners offering cutting edge technology within highly regulated quality systems.
AET BioTech will carry out all of its activities according to the highest standards of ethics, especially in the development and testing of its biosimilar projects, and in its interactions with third parties. In close consultation with regulatory authorities, AET BioTech will avoid or at least minimise in vivo studies during clinical and testing wherever possible.
A longtime strength of AET (Alfred E. Tiefenbacher GmbH & Co. KG) has been its close and collaborative relationships with regulatory authorities, based on obtaining thousands of marketing authorisations for complex generics on behalf of marketing companies.
AET BioTech will continue in this vein, communicating and engaging with regulatory authorities around the world from the conception of the project plan with regular scientific advice sessions, through to the subsequent submission of marketing authorisation applications, which it will manage and support on behalf of and with marketing partners globally, gaining marketing authorisations and assisting with their maintenance thereafter.
AET BioTech has access to a network of CROs worldwide with an excellent track record and experience of effectively recruiting for and executing complex efficacy trials in various indications. These CROs have experience of working to simultaneously match diverse regulatory requirements of worldwide markets.
During the entire product development and also in the later commercial phase of the projects, AET BioTech will implement transparent and controllable production processes. For the period after product launch by marketing partners, AET BioTech will closely collaborate with them to ensure that they can meet pharmacovigilance guidelines for their markets.
Based on market expectations and forecasts, AET BioTech will select the most suitable manufacturing partners under consideration of overall experience, experience with biosimilars, commitment and both short and long term supply costs.