Repligen Launches the CTech™ SoloVPE® PLUS System
Repligen (NASDAQ:RGEN) has launched the CTech™ SoloVPE® PLUS System, an advanced UV-based Variable Pathlength Technology system for biopharmaceutical manufacturers. This next-generation system delivers precise concentration measurements in under 30 seconds without requiring dilution or background correction.
The system addresses the bioprocess industry's shift toward higher drug concentration formulations, offering key advantages including: 70% reduction in process steps, doubled data collection speed, measurement capability for mAbs from 0.01 mg/mL to 320 mg/mL with R²≥ 0.999, and elimination of dilution requirements. Applications include protein concentration measurement, nucleic acids quantitation, and mRNA measurement in therapeutics.
The system integrates with CTech™ ViPER® ANLYTX Software, featuring SQL data storage and OPC-UA communication for real-time access and scalable operations. This launch marks the first of several planned product releases for 2025.
Repligen (NASDAQ:RGEN) ha lanciato il CTech™ SoloVPE® PLUS System, un sistema avanzato di tecnologia a lunghezza d'onda variabile basato su UV per i produttori biopharmaceutici. Questo sistema di nuova generazione fornisce misurazioni di concentrazione precise in meno di 30 secondi senza necessità di diluizione o correzione di sfondo.
Il sistema affronta il cambiamento dell'industria dei bioprocessi verso formulazioni con concentrazioni di farmaci più elevate, offrendo vantaggi chiave che includono: una riduzione del 70% nei passaggi di processo, una velocità di raccolta dati doppia, capacità di misurazione per mAbs da 0,01 mg/mL a 320 mg/mL con R²≥ 0,999, e l'eliminazione dei requisiti di diluizione. Le applicazioni includono la misurazione della concentrazione proteica, la quantificazione degli acidi nucleici e la misurazione dell'mRNA nelle terapie.
Il sistema si integra con il software CTech™ ViPER® ANLYTX, che presenta uno storage dei dati SQL e comunicazione OPC-UA per accesso in tempo reale e operazioni scalabili. Questo lancio segna il primo di diversi rilasci pianificati per il 2025.
Repligen (NASDAQ:RGEN) ha lanzado el CTech™ SoloVPE® PLUS System, un sistema avanzado de tecnología de longitud de camino variable basado en UV para fabricantes biofarmacéuticos. Este sistema de nueva generación ofrece mediciones de concentración precisas en menos de 30 segundos sin necesidad de dilución o corrección de fondo.
El sistema aborda el cambio de la industria de bioprocesos hacia formulaciones de fármacos con mayor concentración, ofreciendo ventajas clave que incluyen: una reducción del 70% en los pasos del proceso, el doble de velocidad en la recolección de datos, capacidad de medición para mAbs de 0,01 mg/mL a 320 mg/mL con R²≥ 0,999 y eliminación de los requisitos de dilución. Las aplicaciones incluyen la medición de concentración de proteínas, cuantificación de ácidos nucleicos y medición de mRNA en terapias.
El sistema se integra con el software CTech™ ViPER® ANLYTX, que cuenta con almacenamiento de datos SQL y comunicación OPC-UA para acceso en tiempo real y operaciones escalables. Este lanzamiento marca el primero de varios lanzamientos de productos planeados para 2025.
Repligen (NASDAQ:RGEN)은 생물 의약품 제조업체를 위한 UV 기반의 가변 경로 길이 기술 시스템인 CTech™ SoloVPE® PLUS System을 출시했습니다. 이 차세대 시스템은 희석이나 배경 보정 없이 30초 이내에 정확한 농도 측정을 제공합니다.
이 시스템은 생물 공정 산업이 더 높은 약물 농도 제형으로 전환함에 따라 몇 가지 주요 이점을 제공합니다. 이점에는: 공정 단계 70% 감소, 데이터 수집 속도 두 배, R²≥ 0.999에서 0.01 mg/mL에서 320 mg/mL까지의 mAb 측정 능력, 그리고 희석 요건의 제거가 포함됩니다. 응용 분야로는 단백질 농도 측정, 핵산 정량 및 치료제에서의 mRNA 측정이 포함됩니다.
이 시스템은 SQL 데이터 저장 및 실시간 접근성과 확장 가능한 작업을 위해 OPC-UA 통신 기능을 갖춘 CTech™ ViPER® ANLYTX 소프트웨어와 통합됩니다. 이번 출시로 인해 2025년을 위한 여러 제품 출시 계획 중 첫 번째가 이루어졌습니다.
Repligen (NASDAQ:RGEN) a lancé le CTech™ SoloVPE® PLUS System, un système avancé de technologie à longueur de chemin variable à base d'UV pour les fabricants biopharmaceutiques. Ce système de nouvelle génération fournit des mesures de concentration précises en moins de 30 secondes sans nécessiter de dilution ni de correction de fond.
Le système répond à l'évolution de l'industrie des bioprocédés vers des formulations à concentration médicamenteuse plus élevée, offrant des avantages clés tels qu'une réduction de 70% des étapes du processus, un doublement de la vitesse de collecte des données, une capacité de mesure pour les mAbs de 0,01 mg/mL à 320 mg/mL avec R²≥ 0,999, et l'élimination des exigences de dilution. Les applications incluent la mesure de la concentration des protéines, la quantification des acides nucléiques et la mesure de l'ARNm dans les traitements.
Le système s'intègre avec le logiciel CTech™ ViPER® ANLYTX, qui présente un stockage de données SQL et une communication OPC-UA pour un accès en temps réel et des opérations évolutives. Ce lancement marque le premier d'une série de lancements de produits planifiés pour 2025.
Repligen (NASDAQ:RGEN) hat das CTech™ SoloVPE® PLUS System eingeführt, ein fortschrittliches UV-basiertes System mit variabler Pfadlängen-Technologie für biopharmazeutische Hersteller. Dieses System der nächsten Generation liefert präzise Konzentrationsmessungen in unter 30 Sekunden, ohne dass eine Verdünnung oder Hintergrundkorrektur erforderlich ist.
Das System reagiert auf den Wandel der Bioprozessindustrie hin zu Formulierungen mit höheren Arzneimittelkonzentrationen und bietet wichtige Vorteile, darunter: 70% Reduktion der Prozessschritte, doppelte Datenerfassungsrate, Messfähigkeit für mAbs von 0,01 mg/mL bis 320 mg/mL mit R²≥ 0,999 und die Beseitigung von Verdünnungsanforderungen. Anwendungen umfassen die Messung von Proteinkonzentrationen, die Quantifizierung von Nukleinsäuren und die Messung von mRNA in Therapeutika.
Das System integriert sich mit der CTech™ ViPER® ANLYTX-Software, die SQL-Datenspeicherung und OPC-UA-Kommunikation für den Echtzeitzugriff und skalierbare Operationen bietet. Diese Markteinführung ist die erste von mehreren geplanten Produkteinführungen für 2025.
- Launch of new advanced bioprocessing measurement system
- 70% reduction in process steps (from 7 to 2 steps)
- 50% faster data collection compared to legacy system
- Enhanced measurement range (0.01-320 mg/mL) with high accuracy (R²≥ 0.999)
- None.
Insights
The launch of the CTech™ SoloVPE® PLUS System represents a strategic advancement in bioprocess analytics. The system's ability to measure concentrations up to 320 mg/mL without dilution and deliver results in under 30 seconds directly addresses critical bottlenecks in biopharmaceutical manufacturing. This positions Repligen to capture significant market share in the growing high-concentration biologics segment.
The 70% reduction in process steps and elimination of dilution requirements will translate to substantial operational cost savings for manufacturers. Integration with SQL databases and OPC-UA compatibility indicates strong potential for adoption in Industry 4.0 initiatives, particularly valuable for companies transitioning to automated manufacturing.
The timing aligns perfectly with the industry's shift toward higher drug concentration formulations, especially in the expanding antibody-drug conjugate (ADC) and mRNA therapeutic markets. The system's versatility across multiple applications (proteins, nucleic acids, mRNA) broadens its market potential significantly.
This product launch strengthens Repligen's competitive position in the $8.2B market cap bioprocessing technology sector. The enhanced capabilities of the PLUS system create potential for both new customer acquisition and upgrade sales to existing SoloVPE users. The timing of this launch as the first of multiple planned product releases in 2025 suggests a robust product pipeline that could drive revenue growth.
The system's focus on efficiency and cost reduction aligns with current market demands for process optimization in biomanufacturing. The expanded concentration measurement range (0.01-320 mg/mL) and improved accuracy (R²≥0.999) position this as a premium offering, likely commanding higher margins than previous generations.
Integration capabilities with modern data management systems address the growing demand for connected manufacturing solutions, potentially leading to longer-term customer relationships through ecosystem lock-in effects.
Next-Generation At-Line Concentration Measurement for Bioprocessing
WALTHAM, Mass., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of its CTech™ SoloVPE® PLUS System, the most advanced UV-based Variable Pathlength Technology system now available to biopharmaceutical manufacturers. The SoloVPE PLUS System is engineered to offer unparalleled accuracy, speed, and ease-of-use for at-line ultraviolet-visible (UV-Vis) concentration measurement in complex biological production workflows, from process development scale through cGMP manufacturing.
As the bioprocess industry shifts toward higher drug concentration formulations to improve efficiency and reduce production costs, there has been a growing need for faster, more reliable and more accurate analytical tools. The SoloVPE PLUS System addresses this need, utilizing variable pathlength spectroscopy to deliver precise concentration measurements in under 30 seconds, without the need for dilution or background correction.
This innovative technology is a significant addition to Repligen’s process analytics portfolio, advancing the company’s at-line capabilities and complementing both its in-line, real-time FlowVPX® System and fully integrated RPM™ (Real-time Process Management) TFF Systems. Applications for the SoloVPE PLUS System include measurement of protein concentration (such as for antibody-based drugs, including ADC drug-to-antibody ratio), quantitation of nucleic acids (DNA/RNA) and measurement of mRNA in mRNA-based therapeutics.
Olivier Loeillot, President and Chief Executive Officer at Repligen said, “The next-generation SoloVPE PLUS System is a success for our development team, delivering on the goal to achieve a new level of speed, precision and reproducibility. It’s an exciting advance for Repligen - and just the first of many new product launches we have planned for 2025.”
Kola Otitoju, Senior Vice President and Global Head of Process Analytics, said, “Repligen is at the forefront of PAT innovation, and the new SoloVPE PLUS System showcases our ability to evolve our bioprocessing technologies to meet our customers’ needs. The SoloVPE PLUS System delivers on the key performance factors required to support faster decision-making and greater efficiency, helping our customers improve both their productivity and bottom line."
The SoloVPE PLUS System offers several key advantages over current UV-Vis spectroscopy offerings in the market:
- Streamlined Workflow. Reduces process steps by
70% , from a seven-step process to just two - measure and report. - Accelerated Acquisition Speed. Doubles the speed of data collection, delivering results in half the time compared to the legacy SoloVPE System.
- Enhanced Sensitivity and Reproducibility. Measures the widest range of concentrations without dilution—mAbs from 0.01 mg/mL to 320 mg/mL, with an R²≥ 0.999.
- Minimized Error-Prone Steps. Direct measurement of samples eliminates the need for dilution or additional sample preparation.
- Optimized Data Management. The CTech™ ViPER® ANLYTX Software integrates SQL for data storage and retrieval, and OPC-UA for standardized communication, enabling a streamlined, agile, and connected system that supports real-time access and scalable bioprocessing operations.
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 SoloVPE PLUS systems on Repligen’s future financial performance, customer adoption of the SoloVPE PLUS, 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
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ef007654-8d91-436b-80aa-1223559a5a0f
FAQ
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