Asahi Kasei Medical launches Planova™ FG1 next-generation virus removal filter
Asahi Kasei Medical has launched Planova™ FG1, a next-generation virus removal filter for biotherapeutics manufacturing, in October 2024. The new filter offers higher flux, approximately 7 times that of Planova™ BioEX, enabling shorter virus filtration time and less risk of virus breakthrough during process suspension. Planova™ FG1 demonstrated high protein filtration and virus removal performance under various conditions, even without a prefilter. It is compatible with standard cleaning and sterilization processes, allowing use with existing biopharmaceutical manufacturing equipment.
Asahi Kasei Medical plans to expand the Planova™ FG1 lineup with larger surface area filters to support efficient process scale-up. The launch aims to solidify the Planova™ brand's presence among biopharmaceutical manufacturers and contribute to safer, more efficient pharmaceutical production as demand for biopharmaceuticals grows by 5-10% annually.
Asahi Kasei Medical ha lanciato Planova™ FG1, un filtro per la rimozione dei virus di nuova generazione per la produzione di bioterapeutici, nell'ottobre 2024. Il nuovo filtro offre un flusso superiore, circa 7 volte quello del Planova™ BioEX, consentendo tempi di filtrazione dei virus più brevi e meno rischi di attraversamento dei virus durante la sospensione del processo. Planova™ FG1 ha dimostrato prestazioni elevate nella filtrazione delle proteine e nella rimozione dei virus in diverse condizioni, anche senza un prefiltro. È compatibile con i processi standard di pulizia e sterilizzazione, permettendo l'uso con l'attrezzatura esistente per la produzione biopharmaceutica.
Asahi Kasei Medical prevede di espandere la gamma di Planova™ FG1 con filtri a superficie più ampia per supportare una scala di processo efficiente. Il lancio mira a consolidare la presenza del marchio Planova™ tra i produttori di biopharmaceuticals e contribuire a una produzione farmaceutica più sicura ed efficiente, poiché la domanda di biopharmaceuticals cresce del 5-10% annualmente.
Asahi Kasei Medical ha lanzado Planova™ FG1, un filtro para la eliminación de virus de nueva generación para la fabricación de bioterapéuticos, en octubre de 2024. El nuevo filtro ofrece un flujo más alto, aproximadamente 7 veces el de Planova™ BioEX, permitiendo tiempos de filtración de virus más cortos y menos riesgo de ruptura de virus durante la suspensión del proceso. Planova™ FG1 demostró un alto rendimiento en la filtración de proteínas y eliminación de virus bajo diversas condiciones, incluso sin un prefiltro. Es compatible con los procesos estándar de limpieza y esterilización, permitiendo su uso con el equipo existente de fabricación biopharmaceutica.
Asahi Kasei Medical planea ampliar la línea Planova™ FG1 con filtros de mayor área superficial para apoyar la escalabilidad eficiente del proceso. El lanzamiento tiene como objetivo consolidar la presencia de la marca Planova™ entre los fabricantes de biopharmaceuticals y contribuir a una producción farmacéutica más segura y eficiente, ya que la demanda de biopharmaceuticals crece entre un 5 y un 10% anualmente.
아사히 카세이 메디컬은 2024년 10월에 Planova™ FG1을 출시했습니다. 이는 바이오 치료제 제조를 위한 차세대 바이러스 제거 필터입니다. 새로운 필터는 상승한 유량을 제공하여 Planova™ BioEX의 약 7배에 달하며, 바이러스 여과 시간을 단축시키고 과정 중 바이러스 침입의 위험을 줄여줍니다. Planova™ FG1은 다양한 조건에서 높은 단백질 여과 및 바이러스 제거 성능을 보여주었으며, 프리필터 없이도 작동이 가능합니다. 기존의 바이오 의약품 제조 장비와 호환되는 표준 청소 및 멸균 프로세스를 지원합니다.
아사히 카세이 메디컬은 효율적인 공정 확장을 지원하기 위해 더 큰 면적의 필터와 함께 Planova™ FG1 라인업을 확장할 계획입니다. 이번 출시의 목표는 바이오 제약 제조업체들 사이에서 Planova™ 브랜드의 존재감을 강화하고, 바이오 제약에 대한 수요가 연간 5-10% 성장함에 따라 더 안전하고 효율적인 제약 생산에 기여하는 것입니다.
Asahi Kasei Medical a lancé Planova™ FG1 en octobre 2024, un filtre de prochaine génération pour l'élimination des virus destiné à la fabrication de biothérapeutiques. Le nouveau filtre offre un débit supérieur, environ 7 fois celui de Planova™ BioEX, permettant des temps de filtration des virus plus courts et un risque réduit de dépassement de virus lors de la suspension du processus. Planova™ FG1 a démontré des performances élevées en matière de filtration des protéines et d'élimination des virus dans diverses conditions, même sans préfiltre. Il est compatible avec les processus standards de nettoyage et de stérilisation, permettant son utilisation avec les équipements de fabrication biopharmaceutique existants.
Asahi Kasei Medical prévoit d'élargir la gamme de Planova™ FG1 avec des filtres de plus grande surface afin de soutenir l'échelle efficace des processus. Le lancement vise à consolider la présence de la marque Planova™ parmi les fabricants de biopharmaceutiques et à contribuer à une production pharmaceutique plus sûre et plus efficace alors que la demande pour les biopharmaceutiques augmente de 5 à 10% chaque année.
Asahi Kasei Medical hat im Oktober 2024 Planova™ FG1 eingeführt, einen Virusentfernungsfilter der nächsten Generation für die Herstellung von Biotherapeutika. Der neue Filter bietet einen höheren Durchfluss, etwa das 7-Fache des Planova™ BioEX, was kürzereVirusfilterzeiten und ein geringeres Risiko eines Virusdurchbruchs während des Prozessstillstands ermöglicht. Planova™ FG1 zeigte hohe Leistung bei der Proteinfiltration und Virusentfernung unter verschiedenen Bedingungen, auch ohne Vorfilter. Er ist mit den gängigen Reinigungs- und Sterilisationsprozessen kompatibel und kann mit vorhandenen biopharmazeutischen Produktionsanlagen verwendet werden.
Asahi Kasei Medical plant, die Produktpalette von Planova™ FG1 mit größeren Filtern zu erweitern, um eine effiziente Prozessskalierung zu unterstützen. Der Launch zielt darauf ab, die Präsenz der Marke Planova™ unter den Herstellern von Biopharmazeutika zu festigen und zu einer sichereren und effizienteren pharmazeutischen Produktion beizutragen, da die Nachfrage nach Biopharmazeutika jährlich um 5-10% wächst.
- Launch of Planova™ FG1 next-generation virus removal filter with higher flux
- Approximately 7 times higher flux compared to Planova™ BioEX
- Shorter virus filtration time and reduced risk of virus breakthrough
- High protein filtration and virus removal performance without prefilter
- Compatible with standard cleaning and sterilization processes
- Planned expansion of product lineup with larger surface area filters
- None.
Planova™ FG1 (filter with effective surface area of 0.0003 m2 at left, 0.3 m2 at right) (Photo: Business Wire)
The bioprocess business of Asahi Kasei Medical comprises Planova™ virus removal filters and equipment used in the manufacturing process of biotherapeutic products such as biopharmaceuticals and plasma derivatives, biosafety testing services, and biopharmaceutical CDMO operations. It is one of the Asahi Kasei Group’s businesses to drive future growth.
Sold since 1989, Planova™ had its product lineup expanded in 2009 with the launch of Planova™ BioEX hydrophilic PVDF hollow-fiber membrane filters, and in 2022 with the launch of Planova™ S20N next-generation cellulose hollow-fiber membrane filters, meeting heightened standards for the viral safety of biotherapeutics around the world. The new Planova™ FG1 is expected to further contribute to improved productivity as demand for monoclonal antibodies and other biopharmaceuticals steadily grows by 5–
Developed to maximize productivity in the process of manufacturing biopharmaceuticals, Planova™ FG1 provides high performance in terms of the filtration speed and robustness in virus removal capability. Its high flux is approximately 7 times that of Planova™ BioEX, enabling virus filtration time to be shortened, and it features less risk of virus breakthrough when the filtration process is suspended. Customer evaluation in the development stage of Planova™ FG1 confirmed high protein filtration and virus removal performance under various conditions using several solutions, even without a prefilter to remove aggregates. Planova™ FG1 is also compatible with standard cleaning in place (CIP) and sterilization in place (SIP) processes, allowing it to be used with many types of existing equipment for biopharmaceutical manufacturing.
Following the October 2024 start of mass production and shipment of smaller filters of Planova™ FG1, Asahi Kasei Medical will successively extend the product lineup with new filters having larger surface areas to support its customers in efficiently scaling up their process. By adding Planova™ FG1 to its broad lineup of products, Asahi Kasei Medical will further solidify the presence of the Planova™ brand among biopharmaceutical manufacturers and contribute to the safer and more efficient production of pharmaceuticals.
“Asahi Kasei Medical is thrilled to launch the Planova™ FG1 next-generation virus removal filter,” said Ken Shinomiya, President of Asahi Kasei Medical. “We look forward to continuing to support biopharmaceutical manufacturers with our broad and growing lineup of products that help them to safely and efficiently manufacture pharmaceuticals that patients can trust.”
For more information, visit https://planova.ak-bio.com/products_services/planova-FG1/.
For product inquiries, visit https://planova.ak-bio.com/campaign/fg1/
About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. For more information, visit www.asahi-kasei.com.
Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241021084085/en/
North America Contact:
Asahi Kasei America Inc.
Christian OKeefe
christian.okeefe@ak-america.com
Europe Contact:
Asahi Kasei Europe GmbH
Sebastian Schmidt
sebastian.schmidt@asahi-kasei.eu
Source: Asahi Kasei Medical
FAQ
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