By Peter Levison – Executive Director Business Development
In the market trends driving the need for continuous processing, I proposed that one approach to improving patient access to medicines could be through implementation of continuous processing in the manufacture of these therapeutics. Within the biotech sector productivity, which can be measured in terms of numbers of therapeutic doses produced per year per m2 of facility footprint, can be improved without compromising product quality by implementing continuous processing operations.
Today multiple suppliers offer commercial process solutions for continuous cell culture, continuous clarification, continuous chromatography, continuous virus inactivation and continuous filtration and their effectiveness is documented in the technical literature1-4. A benefit associated with continuous manufacture is improved product quality due to the very nature of a continuous process where consistency and robust operation is built in. Notwithstanding the process economic benefits that continuous operations may bring5 there is still a concern that the transition from batch operations to continuous or hybrid processes will bring regulatory challenges that need to be addressed. We do hear supportive presentations given by associates from the regulatory agencies around the world at international bioprocessing conferences that have a continuous thread and regulatory publications are available6. Earlier in 2019, BiosanaPharma got approval to start a phase I clinical trial for a biosimilar version of omalizumab, the first monoclonal antibody produced with a fully continuous biomanufacturing process7. This was pivotal moment in the acceptance of continuous manufacturing in the Biopharmaceutical sector and hopefully will be the beginning of a new era in commercial bioprocessing.
So, what’s next? We have the tools; the technology is proven and early adopters are active.