Technology transfer is a key milestone in the journey from discovery to full-scale good manufacturing practice (GMP)- compliant manufacturing. Navigating this step while preventing unforeseen issues that can create costly delays is supported best by combining knowledge of a given process with understanding of the technological capabilities.
Different applications have different needs. Some challenges and goals are common to bioreactor processes for suspension and adherent cell culture for production of viral vectors, monoclonal antibodies (MAbs), other recombinant proteins, and vaccines. All those applications need improvements in productivity, yields, and efficiency while maintaining critical quality attributes (CQAs) established at small scale. Such goals can be met only through optimizing the right technology and using it in a way that delivers required performance. Here we discuss how specialist teams at Pall Biotech approach technology transfer and work with end users to ensure a successful outcome. Then we focus on development and technology transfer for a new application of our Allegro STR single-use bioreactor system as a case study.