It Is Great to Be First!

Being first to realize a goal is normally hailed as a great achievement, who ran the first four-minute mile? Not that difficult a trivia question, but who was next to run a four-minute mile? Well that is going to take some time with Google to find the answer. The same can be said for conquering Everest, or flying across the Atlantic and so on. I am sure you can add to the list where the pioneers are remembered, but those who are second are not. But, once the initial achievement is made there are often a series of followers; more than 1400 athletes have subsequently completed sub 4 minute miles.

In bioprocessing, perhaps the tables are turned. When addressed with continuous bioprocessing I often hear, “we do not want to be the first!” Overcoming technical and regulatory challenges has not outweighed the risk of impacting approval timeline of the drug. However, recently BiosanaPharma announced that they have approval to start a phase I clinical trial for a biosimilar version of omalizumab. This is the first monoclonal antibody produced with a fully continuous biomanufacturing process to go into the clinic! Looking for details, BiosanaPharma claim their “3C process offers a 90% reduction in the cost of developing and manufacturing EMA/FDA quality mAbs. The 3C process is a fully-continuous, small footprint platform...”¹.

Full details of the manufacturing method are not disclosed, but it is known that the process embraces perfusion for high cell density combined with countercurrent centrifugation for clarification and continuous countercurrent chromatography. BiosanaPharma reveal that they are “operating under GMP conditions on 50 liter scale (development, clinical and commercial scale). In this set-up a production yield of 1 kg mAb per week can be obtained in continuous mode for months in a row”¹. This a significant step forward for the bioprocessing industry and one that may be considered overdue.

In 2011, Janet Woodcock, Director of Center for Drug Evaluation and Research, famously remarked that “…manufacturing experts from the 1950s would easily recognize the pharma manufacturing processes of today”². It is perhaps no surprise that a biosimilar is first biopharmaceutical to be produced continuously. Time to market is less important and development can begin with the timeline of patent expiration in mind. With so many biosimilars in development BiosanaPharma believe that continuous processing will give them a competitive edge and help them lower the price of future mAbs. This is good for current users of the drug and will open biopharmaceuticals to new markets to which they have been prohibitively expensive.

With this pioneering step, how long will it be before other companies adopt continuous bioprocessing? I expect a further surge in continuous processing. Not only will other companies not want to be left behind, but solving technical and regulatory challenges will lower the barrier of adoption, making the promise of continuous biomanufacturing a reality.

Learn more about continuous bioprocessing in the next blog: Bioburden Control: Concerns in Continuous Bioprocessing.

References:

1. https://www.biosanapharma.com
2. https://www.fda.gov/media/85366/download