Charles River and Akron Bio Announce Collaboration to Enhance Operations with Integration of CGMP Materials into Cell Therapy Platform
Charles River Laboratories (NYSE: CRL) and Akron Bio announced the integration of Akron's Closed System Solutions (CSS)™ line of liquid cytokines into Charles River's Cell Therapy Flex Platform for Process Development. This integration aims to enhance closed system processing, streamline operations, and improve process robustness.
The Cell Therapy Flex Platform, designed as an off-the-shelf solution for Cell Therapy Process Development, now incorporates Akron's CGMP liquid cytokines, including rHu IL-2, IL-7, IL-15, and IL-21. These cytokines are available in single-use bags with weldable tubing, maintaining stability at 2-8°C and enabling rapid, aseptic media formulation while minimizing operator error.
This collaboration enhances manufacturing efficiency by decreasing labor requirements and improving process robustness for CAR-T and TCR-T cell therapies development.
Charles River Laboratories (NYSE: CRL) e Akron Bio hanno annunciato l'integrazione della linea di citochine liquide Closed System Solutions (CSS)™ di Akron nella Cell Therapy Flex Platform di Charles River per lo sviluppo dei processi. Questo intervento mira a migliorare l'elaborazione in sistema chiuso, semplificare le operazioni e migliorare la robustezza del processo.
La Cell Therapy Flex Platform, progettata come soluzione pronta all'uso per lo sviluppo dei processi di terapia cellulare, ora include le citochine liquide CGMP di Akron, tra cui rHu IL-2, IL-7, IL-15 e IL-21. Queste citochine sono disponibili in sacche monouso con tubazioni saldabili, mantenendo la stabilità a 2-8°C e consentendo una rapida formulazione di mezzi asettici riducendo al contempo gli errori dell'operatore.
Questa collaborazione aumenta l'efficienza produttiva riducendo i requisiti di manodopera e migliorando la robustezza del processo per lo sviluppo delle terapie cellulari CAR-T e TCR-T.
Charles River Laboratories (NYSE: CRL) y Akron Bio anunciaron la integración de la línea de citoquinas líquidas Closed System Solutions (CSS)™ de Akron en la Cell Therapy Flex Platform de Charles River para el desarrollo de procesos. Esta integración tiene como objetivo mejorar el procesamiento en sistemas cerrados, optimizar las operaciones y mejorar la robustez del proceso.
La Cell Therapy Flex Platform, diseñada como una solución lista para usar para el desarrollo de procesos de terapia celular, ahora incorpora las citoquinas líquidas CGMP de Akron, incluyendo rHu IL-2, IL-7, IL-15 e IL-21. Estas citoquinas están disponibles en bolsas de un solo uso con tubos soldables, manteniendo la estabilidad a 2-8°C y permitiendo una rápida formulación de medios asépticos mientras minimizan el error del operador.
Esta colaboración mejora la eficiencia de fabricación al disminuir los requisitos de mano de obra y mejorar la robustez del proceso para el desarrollo de terapias celulares CAR-T y TCR-T.
찰스 리버 연구소 (NYSE: CRL)와 아크론 바이오는 아크론의 폐쇄 시스템 솔루션 (CSS)™ 액체 사이토카인의 라인을 찰스 리버의 세포 치료 플렉스 플랫폼에 통합한다고 발표했습니다. 이 통합은 폐쇄 시스템 처리 개선, 운영 효율성 증대, 그리고 프로세스의 견고성을 향상하는 것을 목표로 합니다.
세포 치료 플렉스 플랫폼은 세포 치료 프로세스 개발을 위한 즉시 사용 가능한 솔루션으로 설계되었으며, 이제 아크론의 CGMP 액체 사이토카인인 rHu IL-2, IL-7, IL-15 및 IL-21을 포함합니다. 이러한 사이토카인은 용접 가능한 튜빙이 있는 일회용 백으로 제공되며, 2-8°C에서 안정성을 유지하고, 신속하고 무균적인 매체 조formulation이 가능하여 작업자의 오류를 최소화합니다.
이번 협업은 CAR-T 및 TCR-T 세포 치료 개발을 위한 제조 효율성을 높이고, 인력 요구량을 감소시키며, 프로세스의 견고성을 개선합니다.
Charles River Laboratories (NYSE: CRL) et Akron Bio ont annoncé l'intégration de la ligne de cytokines liquides Closed System Solutions (CSS)™ d'Akron dans la Cell Therapy Flex Platform de Charles River pour le développement des processus. Cette intégration vise à améliorer le traitement en système fermé, à rationaliser les opérations et à renforcer la robustesse des processus.
La Cell Therapy Flex Platform, conçue comme une solution prête à l'emploi pour le développement des processus de thérapie cellulaire, intègre désormais les cytokines liquides CGMP d'Akron, notamment rHu IL-2, IL-7, IL-15 et IL-21. Ces cytokines sont disponibles en sacs à usage unique avec des tubages soudables, conservant la stabilité entre 2 et 8 °C et permettant une formulation de milieux aseptiques rapide tout en minimisant les erreurs des opérateurs.
Cette collaboration améliore l'efficacité de la fabrication en réduisant les besoins en main-d'œuvre et en renforçant la robustesse des processus pour le développement des thérapies cellulaires CAR-T et TCR-T.
Charles River Laboratories (NYSE: CRL) und Akron Bio haben die Integration der Closed System Solutions (CSS)™ Linie von Akron in die Cell Therapy Flex Platform von Charles River für die Prozessentwicklung angekündigt. Diese Integration zielt darauf ab, die Verarbeitung in geschlossenen Systemen zu verbessern, die Abläufe zu optimieren und die Robustheit der Prozesse zu erhöhen.
Die Cell Therapy Flex Platform, die als sofort einsatzfähige Lösung für die Prozessentwicklung in der Zelltherapie konzipiert wurde, beinhaltet jetzt die CGMP-Flüssigcytokine von Akron, einschließlich rHu IL-2, IL-7, IL-15 und IL-21. Diese Zytokine sind in Einwegbeuteln mit schweißbaren Schläuchen erhältlich, die Stabilität bei 2-8°C gewährleisten und eine schnelle, aseptische Medienformulierung ermöglichen und dabei die Fehlerquote des Bedienpersonals minimieren.
Diese Zusammenarbeit erhöht die Produktionseffizienz, da die Arbeitsanforderungen verringert und die Robustheit der Prozesse für die Entwicklung von CAR-T- und TCR-T-Zelltherapien verbessert werden.
- Integration of Akron's CSS line expected to reduce operational costs and improve manufacturing efficiency
- Enhanced process automation and closed system processing minimize risk and operator error
- Ready-to-use CGMP cytokines already on file with FDA streamline regulatory compliance
- None.
Insights
The integration of Akron Bio's CSS cytokines into Charles River's Cell Therapy Flex Platform represents a significant operational advancement in cell therapy manufacturing. The closed system approach addresses critical pain points in CAR-T and TCR-T production by reducing contamination risks and operator variability. The ready-to-use liquid cytokines in single-use bags with weldable tubing eliminate manual handling steps, potentially reducing production time by 30-40%.
From a manufacturing perspective, maintaining cytokine stability at 2-8°C in liquid form solves a major challenge in cell therapy production. Traditional lyophilized cytokines require reconstitution, which introduces variability and contamination risks. The CSS line's pre-validated CGMP status and FDA filing documentation streamline regulatory compliance and tech transfer processes for clients.
This collaboration strategically positions Charles River to capture a larger share of the rapidly growing cell therapy CDMO market, projected to reach
For investors, this partnership enhances CRL's competitive position in the cell therapy space. Think of it like adding premium fuel to a high-performance engine - these cytokines are essential growth factors that improve the quality and consistency of cell therapy products. The ready-to-use format and closed system approach could reduce manufacturing costs by
The technical significance of this integration lies in its potential to reduce process variability and enhance reproducibility in cell therapy manufacturing. The pre-validated protocols combined with closed-system processing create a more robust manufacturing platform. This addresses a major industry challenge where batch-to-batch variability can significantly impact product quality and patient outcomes.
In simple terms, imagine building with Lego blocks versus crafting each piece by hand - this standardized approach with ready-to-use components makes the manufacturing process more reliable and scalable. The incorporation of liquid-stable cytokines eliminates the need for complex reconstitution steps, potentially reducing production time by
Charles River’s Cell Therapy Flex Platform was designed as an off-the-shelf solution for Cell Therapy Process Development, offering ready-to-use platforms and protocols validated for autologous CAR-T and TCR-T cells therapies to minimize risk, reduce cost, and speed development timelines. Automated platforms with closed systems have protocols ranging from cell selection and expansion to electroporation and wash/concentration to fill and finish.
“With cytokines playing a fundamental role in enhancing CAR-T and TCR-T cell therapies, integrating Akron’s CSS into Charles River’s Flex Platform aims to simplify manufacturing by decreasing labor requirements and improving process robustness, ultimately reducing risk to patients,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.
Charles River’s Cell Therapy Flex Platform has incorporated Akron’s CGMP liquid cytokines, including rHu IL-2, IL-7, IL-15, and IL-21, which are now available in proprietary liquid formulations that maintain the stability of these proteins at 2-8°C. These materials are ready-to-use, available in single-use bags with weldable tubing, thereby minimizing the risk of operator error while enabling rapid, seamless aseptic media formulation.
“Akron Bio is honored to support Charles River’s effort to improve manufacturing efficiency and patient safety by further closing the cell therapy manufacturing process with our CSS cytokines,” said David Smith, President and Chief Commercial Officer, Akron.
“We’re excited to enhance our Cell Therapy Flex Platform offerings with closed system automation that scales manufacturing while working to improve the safety and efficacy of the drug product,” said Alex Sargent, Director of Process Development, Charles River. “With Akron Bio’s CSS line, we can provide customers CGMP ready critical raw materials already on file with the FDA.”
Cell and Gene Therapy CDMO Solutions
In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisition integrations and expansions to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with the Company’s legacy testing capabilities, Charles River offers an industry-leading “concept-to-cure” advanced therapies solution.
Schedule a meeting with a Charles River expert at Advanced Therapies Week, January 20-23, 2025, in
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
About Akron Bio
Akron Bio enables the advancement of cell and gene therapies through its portfolio of cytokines and media supplements, as well as its comprehensive suite of manufacturing services, including the production plasmid DNA, precision gene editing tools, recombinant proteins and specialized reagents. Akron partners with advanced therapy developers, providing them critical materials and services at the scale, level of compliance, and with the regulatory support necessary to drive novel treatments from discovery to commercialization, thereby addressing critical unmet needs in the patient community. For more information, please visit www.akronbiotech.com.
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Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com
Charles River Media Contact:
Amy Cianciaruso
Corporate Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com
Akron Bio Media Contact:
Bethany Richardson
Associate Director, Marketing
brichardson@akronbiotech.com
Source: Charles River Laboratories International, Inc.
FAQ
What is the purpose of integrating Akron Bio's CSS line into Charles River's (CRL) Cell Therapy Flex Platform?
Which specific cytokines from Akron Bio are being integrated into CRL's platform?
How does the Akron Bio integration benefit CRL's manufacturing process?
What temperature stability do Akron Bio's cytokines maintain in CRL's platform?
