Repligen Launches Novel AVIPure® dsRNA Resin in OPUS® Pre-packed Columns
Repligen (NASDAQ:RGEN) has launched AVIPure® dsRNA Clear OPUS® columns, a new solution for purifying mRNA therapeutics and vaccines. The product combines Repligen's dsRNA purification resin with pre-packed OPUS columns, offering superior removal of double-stranded RNA impurities from transcribed RNA.
The technology achieves a 2-3 log reduction of dsRNA impurities in one minute of residence time in flow through mode, without requiring heat or solvents. This launch follows Repligen's recent acquisition of Tantti Laboratory Inc., integrating Tantti's DuloCore® bead technology with AVIPure affinity ligands.
The solution aims to address growing market demands for efficient dsRNA removal in mRNA-based biologics, ensuring drug efficacy while preventing undesirable immune responses.
Repligen (NASDAQ:RGEN) ha lanciato AVIPure® dsRNA Clear OPUS® columns, una nuova soluzione per la purificazione di terapie e vaccini a base di mRNA. Il prodotto combina la resina per purificazione dsRNA di Repligen con colonne OPUS pre-impacchettate, offrendo una superiore rimozione delle impurità di RNA a doppio filamento dall'RNA trascritto.
La tecnologia raggiunge una riduzione di 2-3 log delle impurità di dsRNA in un minuto di soggiorno in modalità flusso continuo, senza richiedere calore o solventi. Questo lancio segue l'acquisizione recente da parte di Repligen di Tantti Laboratory Inc., integrando la tecnologia delle perle DuloCore® di Tantti con i ligandi di affinità AVIPure.
La soluzione mira a rispondere alla crescente domanda del mercato per una rimozione efficiente del dsRNA nei biologici a base di mRNA, garantendo l'efficacia del farmaco prevenendo risposte immunitarie indesiderate.
Repligen (NASDAQ:RGEN) ha lanzado AVIPure® dsRNA Clear OPUS® columns, una nueva solución para purificar terapias y vacunas de mRNA. El producto combina la resina de purificación de dsRNA de Repligen con columnas OPUS preempaquetadas, ofreciendo una eliminación superior de impurezas de ARN de doble cadena del ARN transcrito.
La tecnología logra una reducción de 2-3 log de impurezas de dsRNA en un minuto de tiempo de residencia en modo de flujo continuo, sin requerir calor ni disolventes. Este lanzamiento sigue a la reciente adquisición por parte de Repligen de Tantti Laboratory Inc., integrando la tecnología de perlas DuloCore® de Tantti con los ligandos de afinidad AVIPure.
La solución tiene como objetivo atender la creciente demanda del mercado por una eliminación eficiente de dsRNA en biológicos basados en mRNA, asegurando la eficacia del fármaco y previniendo respuestas inmunitarias no deseadas.
Repligen (NASDAQ:RGEN)는 AVIPure® dsRNA Clear OPUS® columns를 출시했습니다. 이는 mRNA 치료제와 백신을 정제하기 위한 새로운 솔루션입니다. 이 제품은 Repligen의 dsRNA 정제 수지와 사전 포장된 OPUS 컬럼을 결합하여 전사된 RNA에서 이중 가닥 RNA 불순물을 우수하게 제거합니다.
이 기술은 흐름 모드에서 1분의 체류 시간 동안 dsRNA 불순물의 2-3 로그 감소를 달성하며, 열이나 용매를 요구하지 않습니다. 이번 출시는 Repligen의 Tantti Laboratory Inc.의 최근 인수에 이어 진행되었으며, Tantti의 DuloCore® 비드 기술을 AVIPure 친화 리간드와 통합하고 있습니다.
이 솔루션은 mRNA 기반 생물학 제품에서 효율적인 dsRNA 제거에 대한 시장의 증가하는 요구를 충족하는 것을 목적으로 하며, 약물의 효능을 보장하고 원치 않는 면역 반응을 방지합니다.
Repligen (NASDAQ:RGEN) a lancé AVIPure® dsRNA Clear OPUS® columns, une nouvelle solution pour purifier les thérapies et vaccins à base de mRNA. Le produit combine la résine de purification dsRNA de Repligen avec des colonnes OPUS préemballées, offrant une supériorité dans l'élimination des impuretés d'ARN double brin de l'ARN transcrit.
La technologie permet une réduction de 2 à 3 log des impuretés de dsRNA en une minute de temps de séjour en mode d'écoulement, sans nécessiter de chaleur ni de solvants. Ce lancement suit l'acquisition récente par Repligen de Tantti Laboratory Inc., intégrant la technologie de perles DuloCore® de Tantti avec les ligands d'affinité AVIPure.
La solution vise à répondre à la demande croissante du marché pour une élimination efficace du dsRNA dans les biologiques à base de mRNA, garantissant l'efficacité des médicaments tout en prévenant les réponses immunitaires indésirables.
Repligen (NASDAQ:RGEN) hat AVIPure® dsRNA Clear OPUS® columns eingeführt, eine neue Lösung zur Reinigung von mRNA-Therapeutika und Impfstoffen. Das Produkt kombiniert das dsRNA-Reinigungsharz von Repligen mit vorverpackten OPUS-Säulen und bietet überlegene Entfernung von doppelsträngigen RNA-Verunreinigungen aus transkribierter RNA.
Die Technologie erzielt in einem Durchflussmodus eine Reduktion der dsRNA-Verunreinigungen um 2-3 Log-Stufen in einer Minute Verweildauer, ohne Heiz- oder Lösemittel zu benötigen. Diese Einführung folgt auf die kürzliche Übernahme von Tantti Laboratory Inc. durch Repligen, bei der die DuloCore®-Perlen-Technologie von Tantti mit den AVIPure-Affinitätsliganden integriert wurde.
Die Lösung zielt darauf ab, dem wachsenden Marktbedarf nach einer effizienten dsRNA-Entfernung in mRNA-basierten Biologika gerecht zu werden und die Wirksamkeit von Arzneimitteln zu gewährleisten, während unerwünschte Immunantworten verhindert werden.
- Innovative product launch combining proprietary technologies
- Achieves 2-3 log reduction of impurities in just one minute
- Eliminates need for heat or solvents, reducing production costs
- First of several planned resin launches for 2025
- Strategic integration of recently acquired Tantti Laboratory technology
- None.
Insights
Breakthrough Innovation for the Purification of mRNA Therapeutics and Vaccines
WALTHAM, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the launch of AVIPure® dsRNA Clear OPUS® columns, a groundbreaking solution designed to simplify and enhance the production of mRNA therapeutics and vaccines. This novel affinity chromatography offering marries Repligen’s breakthrough dsRNA purification resin with its flagship OPUS pre-packed columns. The AVIPure dsRNA Clear resin offers unmatched performance in the removal of double-stranded RNA (dsRNA) impurities from transcribed RNA. As the market for mRNA-based biologics has expanded, so has the critical need for better dsRNA removal, to enable the highest levels of drug efficacy in patients, while reducing or preventing any undesirable immune responses. The AVIPure dsRNA Clear OPUS columns directly address this need, with a convenient, closed system for mRNA manufacturers.
The AVIPure dsRNA Clear resin launch follows last week’s formal completion by Repligen of its acquisition of Tantti Laboratory Inc., announced on July 29, 2024.
Olivier Loeillot, President and Chief Executive Officer for Repligen said, “We are thrilled to be introducing this innovative technology to market. The AVIPure dsRNA Clear resin offering represents the initial of several planned Repligen-owned resin launches in 2025, that combine Tantti’s innovative DuloCore® bead technology with our AVIPure affinity ligands. Add on OPUS, and we believe this is just our first step toward building a portfolio of gold standard products for new modality purification.”
The AVIPure dsRNA Clear resin product combines our proprietary affinity ligands with Tantti’s DuloCore® base bead technology. The result is a 2-3 log reduction of dsRNA impurities in just one minute of residence time in flow through mode. Unlike traditional methods, this advanced solution eliminates the need for heat or solvents, providing an easy-to-use, scalable option for manufacturers, and enabling a highly efficient, cost-effective process that ensures the production of high-purity mRNA therapeutics and vaccines. Designed for flexibility and performance, the resins come pre-packed in OPUS chromatography columns, ensuring seamless integration into biomanufacturing workflows.
Umay Saplakoglu, Vice President of Product Management at Repligen said, “Our AVIPure dsRNA Clear OPUS columns will address one of the critical challenges in the production of mRNA therapeutics by providing a technology that combines speed, scalability and exceptional impurity removal while simplifying the workflow. This launch reaffirms our commitment to enabling our customers to deliver safe, high-quality biotherapeutics while reducing costs.”
For more information about AVIPure dsRNA Clear OPUS Columns, please visit Repligen's website.
About Repligen Corporation
Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. We are “inspiring advances in bioprocessing” for the customers we serve; primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide. Our focus areas are Filtration and Fluid Management, Chromatography, Process Analytics and Proteins. Our corporate headquarters are in Waltham, Massachusetts, and the majority of our manufacturing sites are in the U.S., with additional key sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden. For more information about the company see our website at www.repligen.com, and follow us on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws. Investors are cautioned that statements in this press release which are not strictly historical statements including, without limitation, express or implied statements or guidance regarding the impact of the AVIPure dsRNA Clear OPUS columns on Repligen’s future financial performance, customer adoption of the AVIPure dsRNA Clear OPUS columns, the expected expansion of Repligen’s product lines, and other statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” or “could” and similar expressions, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, as detailed in Repligen’s most recent Annual Report on Form 10-K, subsequently filed Quarterly Reports on Form 10-Q and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. These forward-looking statements reflect management’s current views and are based only on information currently available to us. Repligen does not undertake to update, whether written or oral, any of these forward-looking statements to reflect a change in its views or events or circumstances, whether as a result of new information or otherwise, that occur after the date hereof except as required by law.
Repligen Contact:
Sondra S. Newman
VP, Global Head of Investor Relations
(781) 419-1881
investors@repligen.com
FAQ
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