BioPhorum’s Continuous downstream processing for biomanufacturing: an industry review published in 2019 outlined the technology and regulatory barriers in the continuous downstream processing of therapeutic proteins.
The roadmap received great acclaim, especially because it identified several gaps in the process, including a lack of a control plan for continuous bioprocessing.
To fill this gap, BioPhorum has published a technical white paper called A risk-based blueprint for process control of continuous bioprocessing: Phase1: Generic risk assessment and process control parameters, which gives an overview of an accompanying risk assessment template.
As well as supporting the 2019 continuous bioprocessing roadmap, the new paper acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.
Direction of travel
The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done. Being able to reference BioPhorum’s blueprint will demonstrate to regulators that a manufacturer has followed an industry-agreed route, even if it has adapted this to suit its molecule and production process.
The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach. Ultimately, it will reduce the time to market for medicines, improve quality and lower costs – all of which will help patients.
The Covid-19 pandemic has propelled the blueprint’s publication as it will potentially be useful for manufacturers of any complex protein, such as a viral vaccine.
It’s not a race
At an industry level, there is a real drive for everyone to reach the same goal, but achieving this aim is not seen as a race. “It’s not a competition between biomanufacturers about who gets there first,” said Jonathan Haigh, Vice President Process Development at FUJIFILM Diosynth Biotechnologies, one of the leaders in the continuous bioprocessing space. “It’s actually a journey for the whole industry, from technology suppliers, biomanufacturers, service suppliers and regulators, to get to the point where we’re all doing it, for the benefit of our patients.”
The template provides a baseline for individual continuous bioprocess risk assessments, identifying process parameters and attributes that may significantly impact a continuous process. It is a significant step forward on industry’s journey towards harmonizing operational and regulatory alignment to realize routine continuous bioprocessing. Future steps in the continuous bioprocessing journey include defining a validation plan for a specified control strategy, including scale-down models.