Our Proven Process.
How we ensure your success through process optimization and expertise for cell therapy programs, globally.
The Proven Client Experience with ScaleReady
This is our proven process illustrating how ScaleReady works in a true partnership with your T and NK cell therapy program to enable the successful commercialization of your drug. This is a linear left-to-right, as well as a holistic view, of how we look to simplify, streamline, and scale at every stage by offering expertise and support for your cell therapy program. In an incredibly complex field, there are no shortcuts. Our proven process delivers practical and viable solutions by providing the most simple, scalable, and versatile manufacturing products. And our process is proven, as our products are represented in approved CAR-T drugs around the globe.
Jump to Steps within the Proven Process
Discovery | Proof of Concept | Process Optimization | Protocols | Data Review | Scalable Results | Process Scaling | Commercialization
Discovery
Our Technical Account Managers and Field Application Specialists discover more about your company and program, goals, definitions of success, pain points, and challenges.
Proof of Concept
We supply our gold-standard products risk-free with minimal investment in funds and time. Your dedicated team of experts at ScaleReady arranges for samples or in-person demonstrations to set the stage for process development through custom protocols, testing, and data reviews.
Process Optimization
ScaleReady enables you to develop an optimized process that fits/is tailored to your cell therapy program. We do this by beginning with the end in mind, working through minimal-scale processes optimized for maximum scale. This allows your manufacturing process to scale up, out, and most importantly (and uniquely!), back down as you move into successful process scaling.
There are no shortcuts to cell therapy drug success. We don’t shy away from the hard work that must take place to overcome obstacles to simplifying and streamlining. That’s why it’s crucial to refine and perfect this stage through custom protocols, repeated testing, and data review to hone in on an optimized and scalable process that delivers success.
Protocols
Your custom protocols are created in full collaboration with your ScaleReady optimization expert and are designed for execution in test at minimum scale but planned for maximum scale for a fully streamlined and standardized process. We understand what the goal is, with a continued focus on commercialization, excellence, and success, focusing on simplification and elimination of complexities before automating what’s left.
Product Testing
The testing completed at this stage has 100% translational capabilities, and we prove to you the confidence in the repeatability, consistency, and predictability of outcomes while never sacrificing quality or costs. Your program tests at a minimum scale are fully translational for maximum scale for a completely streamlined and scaled process.
Data Review
Together, your ScaleReady process optimization expert and team members join to review data for optimal results. We work with you to ensure the highest yield in quality and desired results. We commit to sending samples and completing additional testing until we have achieved scaleable results and the process is streamlined and simplified.
Scalable Results
Scalable results are achieved once the results at minimal effort and minimum scale are perfected, and this will produce applicability at a full-scale level. Results from the optimization process wheel must be refined so that minimal scale results can translate to maximum scale and commercialization.
Process Scaling
Successful process scaling is achieved with testing at minimum
scale to optimize, then proving results are repeatable, consistent,
and predictable at large scale. We prove the ability to scale your program and process up, scale it out and critically have the ability to linearly scale down without sacrificing the quality of results or those three tenants. Your process has been simplified, standardized and streamlined, eliminating all unnecessary complexities. No further learning or adaptation is required to move into commercialization, you’ve proved the quality of cells, and now we move to quantity of cells.
Commercialization
Your cell therapy manufacturing process and product are ready for market. Full scale-out is achieved, and drug approvals have been processed. ScaleReady deploys commercialization-level expertise and support to ensure that your supply chain is secure. As new innovations are brought to production, we work with you to continue to look for ways to simplify further and standardize, to optimize and employ cost-reduction efficiencies while never losing our hallmark quality in materials and service. ScaleReady partnership continues in support and service for lifetime success.
Our Proven Process. Your Success.
Review the entire ScaleReady Proven Process in downloadable, printable PDF format. Get to know what separates us from others in the space as we simplify, streamline, standardize, and scale your cell therapy processes more effectively on cost, time, and consistency than any other.
Let us prove to you our process
Testimonials
Lab Operations Manager
Large Biologics Group
Additional ScaleReady Resources
ScaleReady Portfolio Overview
- Portfolio introduction
- G-Rex Bioreactors and raw materials
- Cell processing instruments
G-Rex Closed-system Bioreactors
- G-Rex Bioreactor mechanism of action
- Benefits for cell therapy manufacturing
- GatheRex Cell Harvest Pump
- User testimonials
Cue Cell Processing System Brochure
- Instrument Features
- Applications supported
- Customizable protocol design