Process analytical technology (PAT) integrates analytical technologies into the biomanufacturing process to achieve timely measurement of process parameters and product quality attributes to ensure product quality. For new and emerging complex biologics – such as cell, gene, and RNA therapies (CGTs) designed for patients with high medical needs and typically manufactured in small batch sizes with short shelf lives – there is a need for speed and deeper process understanding. CGTs stand to benefit greatly from employing PAT.
However, with unique critical quality attributes, complex mechanisms of actions and heterogenicity issues, developing PAT approaches for CGTs will likely present additional challenges than those encountered with PAT for more established biologics (e.g., monoclonal antibodies). These may be best addressed by industry working together collaboratively.
BioPhorum Cell and Gene Therapy gathered industry experts together for a two-day virtual event to focus on understanding the challenges and opportunities for PAT in the CGT space, performing industry benchmarking activities, and sharing case studies and suggestions that may ultimately accelerate the implementation of PAT.
This BioPhorum commentary summarizes the CGT industry views on PAT articulated during the virtual event and highlights key takeaways on the benefits and barriers to PAT, unique considerations for PAT in the context of CGTs, and highlights some near-term options to help accelerate these important therapies to patients before implementing PAT.