Koki Obara, marketing manager, Asahi Kasei Medical, delves into the current biopharmaceutical environment, the critical role of virus removal filters, and how Planova FG1 stands to impact the development and production of biopharmaceuticals.
Asahi Kasei
In the rapidly evolving landscape of biopharmaceuticals, innovation is paramount. The introduction of Planova FG1 as a new product showcases significant advancements in the field, particularly in enhancing the safety and efficiency of biopharmaceutical manufacturing.
Understanding the current environment
Trends in biopharmaceutical development have been marked by a shift towards targeting more complex diseases. This shift is driven by the need to offer innovative solutions for diseases that have historically had limited treatment options. For example, though cancer remains a primary focus, there is increasing interest in addressing formidable illnesses such as Alzheimer's disease and autoimmune diseases.
In addition, the acceleration of biosimilar development has introduced a new dimension to the market. Biosimilars are emerging as cost-effective alternatives to existing biopharmaceuticals, driving down prices and expanding access. This price reduction is instrumental in the democratisation of biopharmaceuticals, making these advanced treatments more accessible to wider populations than ever before.
To continue growing/expanding this widespread access, biopharmaceuticals must be produced safely and at a lower cost. Additionally, the manufacturing processes must also adhere to environmental conservation efforts. Companies are increasingly utilising existing infrastructures and working to develop sustainable processes to minimise environmental impact, aligning biopharmaceutical production with Sustainable Development Goals (SDGs).
The role of virus removal filters
VF are essential for biopharmaceutical production, serving as the final defense in ensuring product safety. These systems are responsible for removing potential viral contaminants from medications before they reach patients, safeguarding their health.
The recently revised ICH guidelines clearly state the Log Reduction Value (LRV) of effective virus removal and inactivation processes, reflecting the trend towards strengthening global safety standards. Meeting these stringent demands requires improvements in existing VF processes to ensure compliance and maintain patient trust.
VF operations involve multiple steps, from initial setup to filtration, followed by post-use integrity testing. These steps can extend over an entire day, creating bottlenecks in production. Any reduction in time spent in these stages can significantly enhance productivity, allowing manufacturers to bring products to market more quickly and efficiently.
Introducing Planova FG1: Promise of unrivaled performance
Planova FG1 represents an advancement in the realm of virus filtration. It embodies two attributes critical to biopharmaceutical manufacturing: reliable and rapid.
Reliable: Planova FG1 ensures viral safety in various process conditions as highlighted below, confirming its robustness and reliability.
In addition, Planova FG1 is compatible with SIP (Sterilisation-In-Place) and CIP (Clean-In-Place) processes within stainless steel facilities, broadening its applicability across various manufacturing setups.
Rapid: Planova FG1 boasts a significantly higher filtration speed compared to its predecessors and other high flux filters on the market, potentially contributing to reducing filtration time as demonstrated below. This speed not only enhances manufacturing throughput but also allows flexibility in production scheduling, enabling quicker turnaround of the manufacturing floor.
In consideration of the environmental impact mentioned above, Planova FG1 is shipped sterilised and pre-wetted, reducing time and water usually needed when preparing for filtration.
Conclusion
The introduction of Planova FG1 into the biopharmaceutical manufacturing sector offers a beacon of innovation and progress. These filters will ensure that high standards of safety are maintained without compromising the efficiency and cost-effectiveness of production processes.
Planova FG1 stands to become a key component in aligning the goals of patient safety, cost reduction and environmental responsibility. By reliably and rapidly advancing the virus filtration process, Planova FG1 enhances the overall efficiency of biopharmaceutical manufacturing. It thus supports the broader mission of making advanced therapies accessible to everyone, especially those in underserved communities, further propelling the democratisation of healthcare.
In conclusion, Planova FG1's development is a testament to innovation’s potential in addressing both existing and emerging challenges in the biopharmaceutical industry. By prioritising safety, efficiency and environmental sustainability, Planova FG1 not only enhances current manufacturing processes but also sets a new standard for future developments. As such, Planova FG1 is poised to make significant contributions to the evolution of biopharmaceuticals, ultimately improving patient outcomes and expanding global access to life-changing therapies.