Introducing Pionic: Bridging the Gap in Downstream Process Intensification
Process intensification is widely recognized as an important strategy for enhancing efficiency in biomanufacturing. While upstream processes have seen significant advancements with strategies like intensified seed trains and dynamic perfusion, downstream adoption has faced challenges due to:
- Risk aversion and resistance to change
- Resource-intensive modification of existing infrastructures
- Product quality concerns
Enter Pionic: A New Versatile Downstream Process Intensification Platform
While Pionic is still in development, it promises to address these challenges as a versatile platform capable of performing chromatography, filtration, viral inactivation, and ultrafiltration | diafiltration on a modular platform.
Each unit operation can be intensified and connected individually, offering a flexible solution for connected and continuous downstream processes. Pionic will integrate seamlessly into both new and existing facilities, minimizing disruption to current operations.
Industry Collaborations Reduce Risk
Resistance to change is a common obstacle in the bioprocessing industry, often rooted in the need to ensure stability and reliability. However, embracing innovation is crucial for staying competitive.
Pionic is being developed in collaboration with leading CDMOs and biomanufacturers, ensuring it meets industry standards. Our collaborators, now early adopters, provide an evidence-backed solution that reduces the risk of the unknown.
Adapting Existing Infrastructures
Traditional process platforms are often large, fixed, and inflexible, making them challenging to adapt to connected | continuous downstream process modes. The perception could be that the effort, cost, and time required to change existing infrastructures and the disruption to operations may outweigh the benefits.
Once completed, Pionic aims to be a ready-for-use, modular platform that can seamlessly adapt to both new and existing facilities, accommodating diverse intensification strategies. This will biomanufacturers to take a gradual approach to intensification by identifying unit operations, while paving the way for a connected, continuous downstream process.
Maintaining Product Quality
Establishing a high-performing, reproducible process that adheres to the latest regulations is time-consuming and expensive. Any moves towards increasing productivity must do so without impacting product quality.
Our goal with Pionic is to create a fully automated platform backed by robust analytical tools to ensure tight process control. As such, manufacturers can ensure their process remains reproducible and compliant while leveraging the benefits of process intensification.
We're excited to share a sneak peek into one of the cornerstones of Pionic: continuous viral inactivation.
At a Glance: Continuous Viral Inactivation
Viral inactivation is vital for patient safety in protein-based therapies. However, continuous processing creates some technical challenges for this step, for which incubation time is critical. Ensuring sufficient time for robust viral inactivation is critical, especially because of non-uniform residence times.
Pionic enables low pH virus inactivation under aseptic conditions, with a flow path capable of 28-day operation. It manages all required process steps to inactivate viruses: homogenization, acidification, incubation, and neutralization in continuous mode, handling 1-22 L eluates from clinical to commercial scales.
How Does it Work?
At the heart of the Pionic virus inactivation system is a unique plug flow reactor design, enabling continuous low pH virus inactivation with a narrow residence time distribution. Its modular design accommodates different volumes while maintaining consistent residence times across all flow rates, meeting quality and regulatory standards while achieving process intensification.
Watch This Space
Stay tuned for more on Pionic as we continue to develop this end-to-end solution with end-users, supporting our mission to enable the creation of new and better therapies and more affordable medicine.
Learn more about our process intensification solutions.
