Transcenta – a global biotherapeutics company dedicated to antibody-based biotherapeutics discovery, development and manufacturing – is implementing fully continuous bioprocessing in CMP manufacturing in China. Merck’s BioContinuum Platform and know-how in continuous processing is helping to achieve this vision: advancing Transcenta's Integrated Continuous Bioprocessing (ICB) platform for the manufacture of any protein biologics.
In turn, this collaboration is expected to accelerate affordable access to therapeutics for patients in China and worldwide.
87% reduction in buffer usage
The Merck-Transcenta model will bring teams together in real time to converge single-use, continuous and digital bioprocessing technologies to develop Transcenta’s ICB platform. As part of the initiative, Merck and Transcenta will co-develop a first-of-its-kind, single-use, flow-through polishing system for the ICB platform.
The first phase of the multi-year partnership will focus on developing and designing the process technologies, single-use system and automation. The second will look at expanding the scope of process and digital technologies to optimize the continuous manufacturing process.
The BioContinuum Platform combines intensified, connected and continuous processing with software, automation and analytical technologies (drawing on the Bio4C Software Suite) to help drive a move towards ‘Bioprocessing 4.0’ – an era of increased digitilization and interconnected products and supply chains.
The promise of continuous processing is greater efficiency, productivity and product quality, which will save biomanufacturers valuable time and money while reducing risks, says Darren Verlenden, head of bioprocessing at Merck.
“In the evolution towards continuous processing, flow through polishing provides a logical first step,” he told BioPharma-Reporter. “In our evaluation, we have found significant capacity improvements across ion exchange resins and virus filtration in continuous operation.
"Furthermore, the replacement of a bind and elute cation exchange step with a flow through step results in a significant reduction in the amount of buffer required. These advancements are borne out in cost modelling studies, where we have observed a 43% and 87% reduction in cost of goods and buffer usage, respectively, when comparing traditional with flow through polishing.”
While continuous bioprocessing may bring many advantages, moving from intensified to continuous processing is not without its challenges, noted Verlenden.
“One significant challenge is the increased interplay between unit operations and development with a holistic mindset to meet impurity clearance targets. This approach often requires new technologies in a developer’s toolbox. For example, in flow through polishing, resins such as our Eshmuno CP-FT, designed for flow through cation exchange, are necessary for efficient impurity removal.”
What next for Bioprocessing 4.0?
Bioprocessing 4.0 – like its counterpart Industry 4.0 – is driving a move towards increased digitalization and interconnection of across production. It is defined as a totally end-to-end connected bioprocess, in which all systems and equipment in the process are digitally connected. This can incorporate artificial intelligence and machine learning and further integrated components across workflows, modelling, automation, and cloud and edge-based computing for the data involved.
For Verlenden, the bottom line when it comes to continuous bioprocessing is that it can make new therapies available to patients faster and cheaper. And that will drive continued uptake across the industry.
“Adoption of continuous processing will continue to increase and expand across upstream, downstream and unify the process to deliver new therapies to patients faster and more cost-effectively,” he said. “As biomanufacturers think holistically about their processes, the convergence of process technologies, software, automation and analytics will be required to meet their objectives.
