Mirion to Elevate Radiopharmaceutical Production Quality with Advanced Apex-Guard Software
Mirion Technologies (NYSE: MIR) has launched version 1.2 of its Apex-Guard gamma spectroscopy software, enhancing quality control in radiopharmaceutical production. The updated software introduces a patent-pending algorithm for Radionuclidic purity measurements, supporting compliance with FDA regulations.
The release comes amid rapid expansion in the radiopharmaceutical sector, with over 100 drugs in Phase I or further clinical development. The software builds upon Mirion's Genie™ and Apex-Gamma™ platforms, offering advanced controls, security, and audit features. It integrates with BioTrax QMS®, an electronic quality management system from ec2 Software, a Mirion Medical Company.
This enhancement aims to streamline quality management processes and ensure compliance in radioisotope production, particularly important for cancer care applications.
Mirion Technologies (NYSE: MIR) ha lanciato la versione 1.2 del suo software di spettroscopia gamma Apex-Guard, migliorando il controllo qualità nella produzione di radiofarmaci. Il software aggiornato introduce un algoritmo in attesa di brevetto per le misurazioni di purezza radionuclidica, supportando la conformità alle normative della FDA.
Il rilascio avviene in un contesto di rapida espansione nel settore dei radiofarmaci, con oltre 100 farmaci in fase I o in ulteriore sviluppo clinico. Il software si basa sulle piattaforme Genie™ e Apex-Gamma™ di Mirion, offrendo controlli avanzati, sicurezza e funzionalità di audit. Si integra con BioTrax QMS®, un sistema elettronico di gestione della qualità di ec2 Software, una società di Mirion Medical.
Questo miglioramento mira a semplificare i processi di gestione della qualità e garantire la conformità nella produzione di radioisotopi, particolarmente importante per le applicazioni nella cura del cancro.
Mirion Technologies (NYSE: MIR) ha lanzado la versión 1.2 de su software de espectroscopia gamma Apex-Guard, mejorando el control de calidad en la producción de radiofármacos. El software actualizado introduce un algoritmo pendiente de patente para las mediciones de pureza radionuclidica, apoyando el cumplimiento de las regulaciones de la FDA.
El lanzamiento se produce en medio de una rápida expansión en el sector de los radiofármacos, con más de 100 medicamentos en la Fase I o en desarrollo clínico adicional. El software se basa en las plataformas Genie™ y Apex-Gamma™ de Mirion, ofreciendo controles avanzados, seguridad y características de auditoría. Se integra con BioTrax QMS®, un sistema electrónico de gestión de la calidad de ec2 Software, una empresa de Mirion Medical.
Esta mejora tiene como objetivo simplificar los procesos de gestión de calidad y garantizar el cumplimiento en la producción de radioisótopos, lo cual es especialmente importante para aplicaciones en el cuidado del cáncer.
미리온 테크놀로지스 (NYSE: MIR)는 방사성 의약품 생산의 품질 관리를 향상시키기 위해 Apex-Guard 감마 분광 소프트웨어의 1.2 버전을 출시했습니다. 업데이트된 소프트웨어는 방사성 동위원소 순도 측정을 위한 특허 출원 중인 알고리즘을 도입하여 FDA 규정 준수를 지원합니다.
이번 출시 는 방사성 의약품 분야의 빠른 확장 속에서 이루어지며, 현재 100개 이상의 약물이 1상 또는 추가 임상 개발 중에 있습니다. 이 소프트웨어는 미리온의 Genie™ 및 Apex-Gamma™ 플랫폼을 기반으로 하여 고급 제어, 보안 및 감사 기능을 제공합니다. 또한 미리온 메디컬의 ec2 소프트웨어에서 제공하는 전자 품질 관리 시스템인 BioTrax QMS®와 통합됩니다.
이 개선은 품질 관리 프로세스를 간소화하고 방사성 동위원소 생산에서의 규정 준수를 보장하는 것을 목표로 하며, 이는 특히 암 치료 응용 프로그램에 중요합니다.
Mirion Technologies (NYSE: MIR) a lancé la version 1.2 de son logiciel de spectroscopie gamma Apex-Guard, améliorant le contrôle de la qualité dans la production de radio-pharmaceutiques. Le logiciel mis à jour introduit un algorithme en instance de brevet pour les mesures de pureté radionuclidique, soutenant la conformité aux réglementations de la FDA.
Cette sortie intervient dans un contexte d'expansion rapide du secteur des radio-pharmaceutiques, avec plus de 100 médicaments en phase I ou en développement clinique avancé. Le logiciel s'appuie sur les plateformes Genie™ et Apex-Gamma™ de Mirion, offrant des contrôles avancés, de la sécurité et des fonctionnalités d'audit. Il s'intègre avec BioTrax QMS®, un système électronique de gestion de la qualité d'ec2 Software, une entreprise de Mirion Medical.
Cette amélioration vise à rationaliser les processus de gestion de la qualité et à garantir la conformité dans la production de radio-isotopes, ce qui est particulièrement important pour les applications dans les soins du cancer.
Mirion Technologies (NYSE: MIR) hat die Version 1.2 seiner Apex-Guard-Gamma-Spektroskopie-Software veröffentlicht, die die Qualitätskontrolle in der Produktion von Radiopharmazeutika verbessert. Die aktualisierte Software führt einen patentanmeldeten Algorithmus zur Messung der Radionuclidischen Reinheit ein, der die Einhaltung der FDA-Vorschriften unterstützt.
Die Veröffentlichung erfolgt inmitten einer raschen Expansion im Bereich der Radiopharmazeutika, mit über 100 Arzneimitteln in Phase I oder weiterführender klinischer Entwicklung. Die Software baut auf den Plattformen Genie™ und Apex-Gamma™ von Mirion auf und bietet fortschrittliche Steuerungen, Sicherheit und Audit-Funktionen. Sie integriert sich mit BioTrax QMS®, einem elektronischen Qualitätsmanagementsystem von ec2 Software, einem Unternehmen von Mirion Medical.
Diese Verbesserung zielt darauf ab, die Qualitätsmanagementprozesse zu optimieren und die Einhaltung in der Produktion von radioisotopen zu gewährleisten, was insbesondere für Anwendungen in der Krebsbehandlung wichtig ist.
- Launch of enhanced quality control software for growing radiopharmaceutical market
- Integration with existing quality management systems streamlines operations
- Patent-pending algorithm adds competitive advantage in radiopharmaceutical quality control
- None.
Insights
Mirion's release of Apex-Guard software V1.2 represents a strategic advancement in the company's radiopharmaceutical market positioning. This update introduces patent-pending algorithms for radionuclidic purity measurements, addressing critical quality control needs in an industry experiencing rapid expansion with over 100 drugs in Phase I or later clinical development.
The timing is particularly advantageous as radiopharmaceuticals gain momentum in precision oncology. By focusing on FDA 21 CFR Part 11 compliance and quality management integration, Mirion is targeting a significant pain point for radioisotope producers facing increasing regulatory scrutiny.
What's most notable is how this software connects to Mirion's broader ecosystem. The interoperability with BioTrax QMS from ec2 Software (a Mirion Medical Company) creates valuable synergies across their portfolio. This indicates effective integration of previous acquisitions and thoughtful product development strategy.
While this single software update won't dramatically shift Mirion's
Apex-Guard™ Software Version 1.2 Introduces Robust Impurity Analysis for Enhanced Radioisotope Quality
The radiopharmaceutical field is experiencing rapid expansion, with over 100 drugs currently in Phase I or further clinical development stages1 poised to revolutionize patient-centric diagnosis and treatment in cancer care and other medical specialties. To manage the growth, radioisotope producers require robust quality management and impurity analysis to ensure compliance and patient safety.
Building on the established Mirion Technologies Genie™ and Apex-Gamma™ gamma spectroscopy software platforms, Apex-Guard software offers advanced controls, security, audit features, and data integrity. These features support compliance with regulations such as
Apex-Guard software further enhances the radiopharmaceutical lifecycle through streamlined workflows via interoperability with industry-leader BioTrax QMS®, an electronic quality management tool encompassing inventory management, document management, and production batch records from ec2 Software, a Mirion Medical Company.
“Mirion is deeply committed to providing the most advanced and reliable technologies for the radiopharmaceutical field, which plays a critical role in modern cancer care,” said Tom Logan, Mirion CEO. “The rapid growth in the radiopharmaceutical sector has increased demand for radioisotopes used in cancer care. This new Apex-Guard release demonstrates our investment in aiding the acceleration of these life-changing advancements in precision medicine by ensuring the highest quality and safety standards.”
Mirion’s Role in Radiopharmaceuticals
The Mirion mission is to harness its unrivaled knowledge of ionizing radiation for the greater good of humanity. The mission is embodied by focused innovation across the Mirion Technologies and Mirion Medical groups as evidenced in support of the radiopharmaceutical supply chain. From research and production to practitioner protection and patient care, Mirion provides a comprehensive portfolio of proven solutions from its Mirion Technologies, Capintec, and ec2 Software brands.
For more information about Apex-Guard software, implementation support services, and how it can benefit commercial radioisotope producers, visit mirion.com.
About Mirion
Mirion (NYSE: MIR) is a global leader in radiation safety, science and medicine, empowering innovations that deliver vital protection while harnessing the transformative potential of ionizing radiation across a diversity of end markets. Focused on nuclear and safety, the Mirion Technologies group is committed to powering advancements in nuclear energy through proven radiation safety technologies and expertise. Dedicated to driving better patient outcomes, the Mirion Medical group is focused on improving quality in cancer care through its broad range of solutions that enhance the delivery and ensure safety across the medical landscape. Headquartered in
1ClinicalTrials.gov; An official website of the
221 CFR Part 11 is the United States Food and Drug Administration (FDA) regulation that sets forth the requirements for electronic records and electronic signatures in the pharmaceutical industry.
Mirion, the Mirion logo, Apex-Guard, Genie, Apex-Gamma, and BioTrax QMS are trademarks of Mirion Technologies, Inc. and/or its affiliates in
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Source: Mirion Technologies
FAQ
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