Cygnus Technologies and TriLink BioTechnologies® Collaborate to Launch AccuRes™ Host Cell DNA Quantification Kits
Cygnus Technologies and TriLink BioTechnologies, both part of Maravai LifeSciences (NASDAQ: MRVI), have collaborated to launch Cygnus' AccuRes™ Host Cell DNA Quantification Kits. These kits are designed to recover, amplify, and quantify remaining host cell DNA during biologic drug manufacturing, helping to produce safer and more stable vaccines and therapies.
The AccuRes kits use probe-based quantification for specificity and are compatible with any qPCR instrument that detects FAM signal. They offer unparalleled sensitivity with a limit of detection of 0.6 fg/µL. The all-in-one kit includes reagents for DNA extraction, AccuRes PCR master mix, primer/probe mix, and DNA standard.
This collaboration combines Cygnus' proprietary extraction procedure with TriLink's patented CleanAmp® dNTPs and a Hot Start Taq DNA Polymerase, aiming to surpass regulatory standards for host cell DNA levels in biotherapeutics.
Cygnus Technologies e TriLink BioTechnologies, entrambi parte di Maravai LifeSciences (NASDAQ: MRVI), hanno collaborato per lanciare i kit di quantificazione del DNA cellulare ospite AccuRes™ di Cygnus. Questi kit sono progettati per recuperare, amplificare e quantificare il DNA residuo delle cellule ospiti durante la produzione di farmaci biologici, contribuendo a produrre vaccini e terapie più sicuri e stabili.
I kit AccuRes utilizzano quantificazione basata su sonde per garantire specificità e sono compatibili con qualsiasi strumento qPCR che rileva il segnale FAM. Offrono un'eccezionale sensibilità con un limite di rilevamento di 0,6 fg/µL. Il kit tutto-in-uno include reagenti per l'estrazione del DNA, master mix PCR AccuRes, mix di primer/probe e standard di DNA.
Questa collaborazione combina la procedura di estrazione proprietaria di Cygnus con i dNTP CleanAmp® brevettati di TriLink e una Taq DNA Polimerasi Hot Start, mirando a superare gli standard normativi per i livelli di DNA cellulare ospite nei bioterapeutici.
Cygnus Technologies y TriLink BioTechnologies, ambos parte de Maravai LifeSciences (NASDAQ: MRVI), han colaborado para lanzar los Kits de Cuantificación de ADN de Células Host AccuRes™ de Cygnus. Estos kits están diseñados para recuperar, amplificar y cuantificar el ADN restante de las células host durante la fabricación de fármacos biológicos, ayudando a producir vacunas y terapias más seguras y estables.
Los kits AccuRes utilizan cuantificación basada en sondas para la especificidad y son compatibles con cualquier instrumento de qPCR que detecte la señal FAM. Ofrecen una sensibilidad inigualable con un límite de detección de 0.6 fg/µL. El kit todo-en-uno incluye reactivos para la extracción de ADN, mezcla maestra de PCR AccuRes, mezcla de primers/probes y estándar de ADN.
Esta colaboración combina el procedimiento de extracción patentado de Cygnus con los dNTPs CleanAmp® patentados de TriLink y una Taq DNA Polimerasa de inicio en caliente, con el objetivo de superar los estándares regulatorios para los niveles de ADN de células host en bioterapéuticos.
Cygnus Technologies와 TriLink BioTechnologies는 Maravai LifeSciences(NASDAQ: MRVI)의 일부로, Cygnus의 AccuRes™ 숙주 세포 DNA 정량화 키트를 출시하기 위해 협력했습니다. 이 키트는 생물학적 의약품 제조 중 잔여 숙주 세포 DNA를 회수, 증폭 및 정량화하도록 설계되어 더 안전하고 안정적인 백신과 치료제를 생산하는 데 도움을 줍니다.
AccuRes 키트는 프로브 기반 정량화를 사용하여 특이성을 보장하며 FAM 신호를 감지하는 모든 qPCR 장치와 호환됩니다. 이 키트는 감지 한계가 0.6 fg/µL로 비할 데 없는 감도를 제공합니다. 올인원 키트에는 DNA 추출을 위한 시약, AccuRes PCR 마스터 믹스, 프라이머/프로브 믹스 및 DNA 표준이 포함되어 있습니다.
이번 협력은 Cygnus의 독점 추출 절차와 TriLink의 특허를 받은 CleanAmp® dNTP 및 핫 스타트 Taq DNA 중합효소를 결합하여 생물 치료제에서의 숙주 세포 DNA 수준에 대한 규제 기준을 초과하는 것을 목표로 합니다.
Cygnus Technologies et TriLink BioTechnologies, tous deux membres de Maravai LifeSciences (NASDAQ: MRVI), ont collaboré pour lancer les kits de quantification de l'ADN des cellules hôtes AccuRes™ de Cygnus. Ces kits sont conçus pour récupérer, amplifier et quantifier l'ADN restant des cellules hôtes lors de la fabrication de médicaments biologiques, contribuant à produire des vaccins et des thérapies plus sûrs et plus stables.
Les kits AccuRes utilisent la quantification par sondes pour la spécificité et sont compatibles avec tout instrument qPCR détectant le signal FAM. Ils offrent une sensibilité sans précédent avec une limite de détection de 0,6 fg/µL. Le kit tout-en-un comprend des réactifs pour l'extraction de l'ADN, un mélange maître PCR AccuRes, un mélange de primers/probes et un standard d'ADN.
Cette collaboration combine le procédé d'extraction propriétaire de Cygnus avec les dNTPs CleanAmp® brevetés de TriLink et une Taq ADN polymérase à démarrage à chaud, visant à dépasser les normes réglementaires pour les niveaux d'ADN des cellules hôtes dans les biothérapeutiques.
Cygnus Technologies und TriLink BioTechnologies, beide Teil von Maravai LifeSciences (NASDAQ: MRVI), haben zusammengearbeitet, um die AccuRes™ kits zur Quantifizierung von Wirtszell-DNA von Cygnus auf den Markt zu bringen. Diese Kits sind darauf ausgelegt, verbleibende Wirtszell-DNA während der Herstellung biologischer Medikamente zu gewinnen, zu amplifizieren und zu quantifizieren, um sicherere und stabilere Impfstoffe und Therapien herzustellen.
Die AccuRes-Kits verwenden sondenbasierte Quantifizierung für spezifische Ergebnisse und sind mit jedem qPCR-Gerät kompatibel, das das FAM-Signal erkennt. Sie bieten unübertroffene Sensitivität mit einer Nachweisgrenze von 0,6 fg/µL. Das All-in-One-Kit enthält Reagenzien für die DNA-Extraktion, AccuRes PCR-Mastermix, Primer/Probe-Mix und DNA-Standard.
Diese Zusammenarbeit kombiniert das proprietäre Extraktionsverfahren von Cygnus mit TriLinks patentierten CleanAmp® dNTPs und einer Hot Start Taq DNA-Polymerase, mit dem Ziel, die regulatorischen Standards für Wirtszell-DNA-Niveaus in biotherapeutischen Produkten zu übertreffen.
- Launch of AccuRes™ Host Cell DNA Quantification Kits with high sensitivity (0.6 fg/µL limit of detection)
- Collaboration between Cygnus Technologies and TriLink BioTechnologies, leveraging combined expertise
- All-in-one kit design, potentially reducing costs and improving efficiency for customers
- Compatibility with various qPCR instruments, offering flexibility to users
- None.
Insights
The collaboration between Cygnus and TriLink to launch AccuRes™ Host Cell DNA Quantification Kits is a significant development in biotherapeutic manufacturing. This innovative product addresses a critical need in the industry by offering enhanced sensitivity and specificity in detecting residual host cell DNA, a important safety concern in biologics production.
The kit's ability to detect DNA levels as low as 0.6 fg/µL surpasses current regulatory standards, which typically require levels below 10-100 pg/dose. This improved sensitivity could potentially allow manufacturers to produce safer biotherapeutics and streamline the regulatory approval process.
From an investor's perspective, this collaboration leverages the strengths of both Cygnus and TriLink, potentially increasing Maravai LifeSciences' market share in the rapidly growing biotherapeutics sector. The all-in-one nature of the kit and its compatibility with existing qPCR instruments could drive adoption among biopharmaceutical companies, potentially leading to increased revenue for Maravai in the coming quarters.
This product launch represents a strategic move for Maravai LifeSciences (NASDAQ: MRVI) to strengthen its position in the bioprocessing market. The global bioprocess validation market, which includes DNA quantification, is projected to grow at a CAGR of
By offering a comprehensive solution that addresses regulatory requirements and improves manufacturing efficiency, Maravai could capture a larger share of this growing market. The collaboration between its subsidiaries, Cygnus and TriLink, demonstrates effective synergy within the company, potentially leading to cost efficiencies and improved profit margins.
Investors should monitor Maravai's upcoming quarterly reports for indications of revenue growth in its bioprocessing segment, which could be positively impacted by the AccuRes™ kit launch. However, it's important to note that the full financial impact may take several quarters to materialize as adoption rates among biopharmaceutical companies become clearer.
Cygnus’ AccuRes Kits to recover, amplify, & quantify remaining host cell DNA during biologic drug manufacturing to produce safer, more stable vaccines, therapies, and more
AccuRes Host Cell DNA kits use probe-based quantification to ensure specificity for the target host cell line as opposed to off-target DNA. The FAM-labeled nucleic acid probe is quenched by BHQ-1™ until PCR extension. The kits are compatible with any qPCR instrument that detects FAM signal, eliminating the added cost of purchasing additional equipment or reagents. The all-in-one kit includes all reagents for DNA extraction in a plate or microfuge tube format, AccuRes PCR master mix, primer/probe mix, and DNA standard – all with demonstrated sensitivity (a limit of detection of 0.6 fg/µL).
The all-in-one kit combines Cygnus’ proprietary extraction procedure with a probe-based master mix containing TriLink’s patented CleanAmp® dNTPs and a Hot Start Taq DNA Polymerase.
“This collaboration between Cygnus and TriLink has allowed us to bring decades of experience and advanced technology to the development of AccuRes,” said Alla Zilberman, VP of Technical Marketing and Business Development at Cygnus. “With these novel host cell DNA quantification kits, our customers will be able to utilize Cygnus for all their host cell protein and host cell DNA analysis needs.”
Residual host cell DNA may remain during biotherapeutic manufacturing and needs to be monitored and removed to ensure drug safety and stability. Regulatory standards mandate host cell DNA levels do not exceed 10-100 pg/dose, requiring a sensitive and accurate assay to monitor in-process samples and final drug substances for lot release. AccuRes kits are sensitive and specific for the host cell species, and compatible with various real-time PCR instruments, offering flexibility and cost savings without compromising sensitivity.
“As the industry continues to innovate and develop more complex biotherapeutics, it’s critical we have the capabilities to ensure these drug substances are safe and stable,” shared Justin Barbosa, VP and General Manager of TriLink Discovery. “Our CleanAmp dNTPs improve sensitivity, specificity, and prevent mis-priming -- it’s a great addition to any assay. We’re grateful for the collaboration with Cygnus and look forward to future opportunities.”
To learn more about AccuRes, visit cygnustechnologies.com
About Cygnus Technologies, LLC
Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics as well as in innovative viral clearance solutions. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release.
For more information on Cygnus Technologies, please visit cygnustechnologies.com
About TriLink BioTechnologies
TriLink BioTechnologies, a Maravai LifeSciences company, is a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its patented CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors, and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans.
For more information, visit trilinkbiotech.com
About Maravai LifeSciences
Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.
For more information about Maravai LifeSciences, visit maravai.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20240828957776/en/
Liz Robinson, CG Life
lrobinson@cglife.com
Source: TriLink BioTechnologies
FAQ
What is the purpose of Cygnus Technologies' AccuRes™ Host Cell DNA Quantification Kits?
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How does the collaboration between Cygnus Technologies and TriLink BioTechnologies benefit the AccuRes™ Kits?
What are the regulatory standards for host cell DNA levels in biotherapeutics that AccuRes™ Kits help address?
