The highest quality standards in cell and gene therapy—with the certifications to prove it.
Questionable quality and supply should never slow progress toward cell therapy commercialization. The ScaleReady platform is committed to maintaining a high level of quality, compliance, and supply in the industry, minimizing unexpected product availability gaps that can result in expensive manufacturing delays.
ScaleReady offers unmatched quality standards within the industry. Our industry-leading partnerships ensure our customers access to quality-driven cell expansion technologies, cell processing instruments, and GMP ancillary material. Read more about the quality standards and certifications across our portfolio below.
ScaleReady has the only platform where cells maintain the same phenotype regardless of scale. This dramatically improves the success and speed for translating your research into an impactful cell therapy. How does the ScaleReady platform accomplish such seamless translation? Through intuitive product design and constant raw material quality.
The intuitive design of G-Rex bioreactors is a game-changer for scaling cell therapies. Expanding cells in a research-grade G-Rex multi-well plate or a G-Rex bioreactor follows the same principle: 10 mL of media/cm2 and on demand oxygen provide a natural environment for maximum cell growth. As a result, expansion protocols can be optimized in a research setting and the same protocol can scale linearly into a closed system.
Consistent quality of GMP ancillary materials is critical for reproducibly manufacturing a high quality cell therapy. That’s why our GMP and research-grade products use the same raw materials, clones, and manufacturing processes. Both follow diligent quality control processes to ensure that you can move seamlessly into regulatory agency submissions without disrupting your process.
Recombinant cytokines, cell culture media, and cell activating reagents are manufactured by Bio-Techne following quality and regulatory guidelines.
• R&D Systems ISO 13485 Certificate
• R&D Systems ISO 9001 Certificate
• R&D Systems ISO 14001 Certificate
• R&D Systems MDSAP Certificate
R&D Systems is a registered Medical Device Establishment under the U.S. Food, Drug, and Cosmetic Act, registration number 2182501, and is routinely inspected by the FDA.
Regulatory Guidelines Followed and Applicable Standards Followed
- Quality System Regulations for Medical Devices
- Code of Federal Regulations (21 CFR 820)
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Applicable sections of the World Health Organization Good Manufacturing Practices for Biological Products: TRS, No 822, 1992 Annex 1
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
- The In Vitro Diagnostic Directive 98/79/EC
- The Canadian Medical Device Regulation
Instrument quality: cell processing instruments manufactured in a facility that follows FDA quality management systems regulations
Lovo® and Cue cell processing instruments and consumables are manufactured by Fresenius Kabi following strict quality requirements in their ISO 13485 certified facility.
- Fresenius Kabi ISO 13485 Certificate (manufacturing sites)
- Fresenius Kabi (USA) ISO 9001 Certificate
- Fresenius Kabi (AG) MDSAP Certificate
- Haina, Dominican Republic registration number: 9612051
- Warrendale, PA USA registration number: 3005778453
G-Rex closed-system bioreactor: designed to meet quality certifications and medical device guidelines
G-Rex bioreactors are manufactured by Wilson Wolf Manufacturing following quality and regulatory guidelines required for medical devices.
- Wilson Wolf ISO 13485:2016
- Wilson Wolf’s GatheRex Cell Harvesting Instrument is ETL certified,
conforming to UL STD 61010-1 and certified to CSA STD C22.2 #61010-1.
Wilson Wolf’s manufacturing site in New Brighton, MN, USA is a registered Medical Device Establishment under the U.S. Food, Drug, and Cosmetic Act.
- Registration Number: 3004982543
- G-Rex bioreactors are registered as medical devices by the FDA. View listing here.
Supply agreements and workflow customization that will future-proof your manufacturing process.
We know that supply chain is equally as important as quality. That is why our technical team works closely with you to build GMP reagent forecasting and supply agreements into your scale up and scale out strategy.
Customization by Request
Raw material customization and protocol optimization can greatly improve process efficiency and streamline cell therapy scale up.
Employing dedicated technical teams and stringent product quality, we help companies identify the lowest risk, most cost-effective way to introduce GMP reagents into their process, while maintaining the highest reagent quality.
We offer customized vialing, construct design, formulation, and quality control analysis. Our expert cell processing field application scientists are a dedicated resource for you to adapt Lovo and Cue systems for your process.