ScaleReady and Bio-Techne Announce Optimal Closed System Cytokine Packaged for Single Step Use in Closed System G-Rex® Manufacture of CAR-T and TCR Therapies
ScaleReady and Bio-Techne (NASDAQ: TECH) have launched G-Rex optimized ProPak™ GMP Cytokines, designed for efficient closed system cell and gene-modified cell therapy (CGT) manufacturing. The product consists of a weldable bag with liquid formulated GMP-grade cytokines (IL-7 or IL-15) for CAR-T and TCR-T cell production. Each ProPak™ contains enough cytokines to dose a 1-liter G-Rex bioreactor at 10ng/mL concentration.
This innovation aims to reduce operating costs and complexity in CGT manufacturing by simplifying the process of acquiring, storing, preparing, and administering critical reagents. The product eliminates the need for cytokine reconstitution, enabling a hands-off ballroom style G-Rex manufacturing approach.
ScaleReady e Bio-Techne (NASDAQ: TECH) hanno lanciato G-Rex ottimizzato ProPak™ GMP Cytokines, progettato per una produzione efficiente di terapie cellulari e geniche modificate (CGT) in un sistema chiuso. Il prodotto consiste in un sacchetto saldabile contenente citochine GMP di grado liquido (IL-7 o IL-15) per la produzione di cellule CAR-T e TCR-T. Ogni ProPak™ contiene abbastanza citochine per dosare un bioreattore G-Rex da 1 litro a una concentrazione di 10ng/mL.
Questa innovazione mira a ridurre i costi operativi e la complessità nella produzione di CGT semplificando il processo di acquisizione, stoccaggio, preparazione e somministrazione dei reattivi critici. Il prodotto elimina la necessità di reconstituzione delle citochine, consentendo un approccio alla produzione G-Rex in stile ballroom senza intervento diretto.
ScaleReady y Bio-Techne (NASDAQ: TECH) han lanzado G-Rex optimizado ProPak™ GMP Cytokines, diseñado para una producción eficiente de terapia celular y genética modificada (CGT) en un sistema cerrado. El producto consiste en una bolsa sellable con citoquinas de grado GMP formuladas en líquido (IL-7 o IL-15) para la producción de células CAR-T y TCR-T. Cada ProPak™ contiene suficiente citoquina para dosificar un bioreactor G-Rex de 1 litro a una concentración de 10ng/mL.
Esta innovación tiene como objetivo reducir los costos operativos y la complejidad en la fabricación de CGT al simplificar el proceso de adquisición, almacenamiento, preparación y administración de reactivos críticos. El producto elimina la necesidad de reconstitución de citoquinas, permitiendo un enfoque de fabricación de G-Rex estilo ballroom sin intervención directa.
ScaleReady와 Bio-Techne (NASDAQ: TECH)는 G-Rex 최적화 ProPak™ GMP 사이토카인을 출시하였으며, 이는 효율적인 폐쇄형 시스템에서 세포 및 유전자 변형 세포 치료(CGT) 제조를 위해 설계되었습니다. 이 제품은 liquid GMP 등급 사이토카인(IL-7 또는 IL-15)을 포함한 용접 가능한 가방으로, CAR-T 및 TCR-T 세포 생산을 위한 것입니다. 각 ProPak™은 10ng/mL 농도로 1리터 G-Rex 생물반응기를 투여할 수 있는 충분한 사이토카인을 포함하고 있습니다.
이 혁신은 CGT 제조에서 운영 비용과 복잡성을 줄이기 위해, 중요한 시약의 획득, 저장, 준비 및 관리 프로세스를 간소화하는 것을 목표로 합니다. 이 제품은 사이토카인 재구성을 불필요하게 하여, 직접적인 개입 없이 무대 스타일의 G-Rex 제조 접근 방식을 가능하게 합니다.
ScaleReady et Bio-Techne (NASDAQ: TECH) ont lancé G-Rex optimisé ProPak™ GMP Cytokines, conçu pour la fabrication efficace de thérapies cellulaires et géniques modifiées (CGT) dans un système fermé. Le produit se compose d'un sac soudable contenant des cytokines liquides de qualité GMP (IL-7 ou IL-15) pour la production de cellules CAR-T et TCR-T. Chaque ProPak™ contient assez de cytokines pour doser un bioréacteur G-Rex de 1 litre à une concentration de 10ng/mL.
Cette innovation vise à réduire les coûts opérationnels et la complexité de la fabrication CGT en simplifiant le processus d'acquisition, de stockage, de préparation et d'administration des réactifs critiques. Le produit élimine le besoin de reconstitution des cytokines, permettant une approche de fabrication G-Rex en style ballroom sans intervention directe.
ScaleReady und Bio-Techne (NASDAQ: TECH) haben G-Rex optimierte ProPak™ GMP Zytokine eingeführt, die für eine effiziente Herstellung von Zell- und genmodifizierten Zellexperimenten (CGT) in einem geschlossenen System konzipiert sind. Das Produkt besteht aus einem schweißbaren Beutel mit flüssig formulierten GMP-Grad Zytokinen (IL-7 oder IL-15) für die Produktion von CAR-T- und TCR-T-Zellen. Jede ProPak™ enthält genügend Zytokine, um einen 1-Liter-G-Rex-Bioreaktor mit einer Konzentration von 10ng/mL zu dosieren.
Diese Innovation zielt darauf ab, Betriebskosten und Komplexität in der CGT-Herstellung zu senken, indem der Prozess der Beschaffung, Lagerung, Vorbereitung und Verabreichung kritischer Reagenzien vereinfacht wird. Das Produkt beseitigt die Notwendigkeit der Rekonstitution von Zytokinen und ermöglicht einen unkomplizierten G-Rex-Herstellungsansatz ohne direkte Eingriffe.
- Launch of G-Rex optimized ProPak™ GMP Cytokines for efficient closed system CGT manufacturing
- Product simplifies cytokine handling, potentially reducing operating costs and complexity
- Eliminates need for cytokine reconstitution, enabling hands-off manufacturing approach
- Designed to work with the leading G-Rex platform for CAR-T and TCR-T cell expansion
- None.
The launch of G-Rex optimized ProPakTM GMP Cytokines represents a significant advancement in closed-system cell therapy manufacturing. This innovation addresses key challenges in CAR-T and TCR-T production:
- Simplifies the cytokine preparation process, reducing operational complexity
- Potentially lowers manufacturing costs through streamlined workflows
- Enhances consistency and reproducibility in cell therapy production
The product's integration with the widely-used G-Rex platform could accelerate its adoption in the industry. While this development is promising for Bio-Techne's position in the cell therapy supply chain, its immediate financial impact may be The long-term potential depends on the rate of adoption and the growth of the CAR-T/TCR-T market, which is projected to expand significantly in the coming years.
This product launch aligns with Bio-Techne's strategy to strengthen its position in the high-growth cell and gene therapy market. Key financial implications include:
- Potential for increased recurring revenue from CGT manufacturers
- Enhanced competitive positioning in the specialized reagents market
- Possible margin improvements due to the product's value-added nature
However, the immediate revenue impact may be modest, as adoption and scaling of new manufacturing processes take time. Investors should monitor uptake rates and any subsequent expansions of the ProPakTM line. The partnership with ScaleReady could also lead to further collaborations, potentially opening new revenue streams in the burgeoning cell therapy space.
The ProPakTM GMP Cytokine product consists of a weldable bag filled with liquid formulated GMP-grade cytokines, specifically interleukin-7 (IL-7) or interleukin-15 (IL-15), commonly used in the ex vivo manufacturing of CAR-T and TCR-T cells. The quantity of IL-7 and IL-15 contained in each ProPakTM is sufficient to dose a one (1) liter G-Rex bioreactor at the recommended 10ng/mL concentration. The use of ProPak GMP cytokines will enable manufacturers of CAR-T and TCR-T cell therapies to reduce operating costs and complexity by dramatically simplifying the process of acquiring, storing, preparing, and administering these critical reagents for use in cGMP manufacturing.
"Bio-Techne is deeply committed to highly efficient manufacture of lifesaving cell and gene-modified cell therapies," said Will Geist, President (Protein Sciences) at Bio-Techne Corporation. "ProPakTM GMP Cytokines were optimized for use with the leading G-Rex platform by providing the precise quantity of cytokines needed for highly simplified closed system expansion of CAR-T and TCR-T cell drug products with excellent cell characteristics."
"The G-Rex optimized ProPakTM GMP Cytokine is a differentiated product as it is uniquely designed to enable users of G-Rex to manufacture CAR-T and TCR-T drug products with far more simplicity than is possible with any other cytokine vendor," said Josh Ludwig, Global Commercial Director at ScaleReady. "It eliminates the need for cytokine reconstitution and all of the related headaches in favor of a hands-off ballroom style G-Rex manufacturing approach.
"With the incredible response to our G-Rex Grant Program moving G-Rex into the majority of CGT clinical trials, the G-Rex optimized ProPak is the perfect next step in G-Rex manufacturing simplicity. Grant applicant or not, we will help every G-Rex user cost effectively perform comparability studies to integrate the ProPak GMP Cytokines," concluded Josh Ludwig.
Parties interested in learning more and/or evaluating the ProPakTM GMP Cytokines can reach out to info@scaleready.com .
About ScaleReady
ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing.
CGT entities that rely on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization.
The G-Rex manufacturing platform is now used in
For more information about the ScaleReady G-Rex® Grant Program, please contact info@scaleready.com.
About Bio-Techne Corporation
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit https://www.bio-techne.com or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube.
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
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SOURCE Bio-Techne Corporation
FAQ
What is the new product launched by ScaleReady and Bio-Techne (TECH)?
How does the ProPak™ GMP Cytokine product simplify CGT manufacturing?
What cytokines are included in the ProPak™ GMP Cytokine product?
How much cytokine does each ProPak™ contain for use with G-Rex bioreactors?
