Gen2 G‑Rex®100M-CS:
The gold standard, refined.
A bioreactor with a validated closed and sterile fluid path, engineered for the simplicity complex CGT manufacturing requires.
Gen2 G‑Rex®100M-CS (REF: G281100-CS) is a single-use bioreactor engineered with a highly gas-permeable membrane to automatically provide oxygenation to the cells in a standard incubator common to all cell culture labs and GMP manufacturing suites. A large reservoir of media, titrated to the golden ratio (10mL/cm2) provides a properly sized nutrient pool and waste sink to enable robust expansion without the need to exchange culture media. This simple and elegant approach reduces reliance on manual operator intervention as well as eliminating the unnecessary complexity of mechanized bioreactors that rely on perfusion of culture media and agitation of the culture environment.
Technical Architecture
The myriad of customer driven refinements are bucketed into categories intended to afford G‑Rex® users with a suite of features aimed at providing additional device security.
The closure that can’t be undone.
Although Gen1 G‑Rex®100M-CS has a validated closed and sterile fluid path, its removable, threaded cap with PVC tubing pulled over barbs is a potential source of "open-ness" in the manufacturing process.
The multi-port cap on Gen2 G‑Rex®100M-CS features an injection-molded polycarbonate material (consistent with Gen2 G‑Rex®500M-CS), a snap-fit design, and bonded PVC tubing. In short, this is a secure seal that cannot be removed easily.
Unless your process intentionally requires the removal of the Gen1 threaded cap (against the manufacturer's recommendations), this upgrade will not affect manufacturing operations. From a QC perspective, numerous failure modes have been eliminated, bolstering the integrity of the device's closed and sterile fluid path.
Managed tubing. Not loose lines.
Although Gen1 G‑Rex®100M-CS arrives in packaging with the tubing set neatly wrapped around the shell and secured with fittings, user feedback uncovered that technicians and manufacturers often don't re-wrap with the same precision. This leads to loosely wrapped tubing sets each time.
An external, dual-ring, tubing management system elegantly secures the tubing set into a curated, vertical column. Internal cell concentration and harvest tubes are secured in place.
The external tubing management system provides a neat and ergonomic solution for clinical and commercial manufacturing. The fixed internal tubing lines promote greater consistency and reproducibility in cell concentration and harvest. All improvements are designed to structurally and systematically reduce quality risk.
On the Floor: What Changes When You Run Gen2 G‑Rex®100M-CS
Optimized for operational excellence, simplicity and control.
Fewer luers. Fewer ports. A simplified tubing architecture. Each of these changes removes a handling step, a decision point, or a place where variability can enter the process. For technicians, that means less to manage during repetitive tasks. For MSAT and Process Development, it means a device that fits cleanly into a standardized, repeatable workflow. All built to reduce operator variability, not just operator effort.
Simplified
The Gen2 G‑Rex®100M-CS is simplified through the sterile fluid path and the elimination of parts once relevant (e.g. luer connections) as well as the addition of new quality-of-life improvements such as a high-contrast jet black base for visualization of your cells and color-coded clamps when controlling the fluid flow.
Standardized
The G‑Rex®2 G‑Rex®100M-CS is standardized through a fluid management system that ensures a consistent consumables tubing set configuration and reconfiguration process for both human and robotic operators.
Sealed
The closed system and sterile integrity of the Gen2 G‑Rex®100M-CS is immutably sealed through the snap-fit design of the multi-port cap.
Technical specifications
Gen1 vs. Gen2: The Full Feature List
A list of changes, organized into a suite of new features, aimed at simplifying, standardizing, and securing the Gen2 G‑Rex®100M-CS's validated closed and sterile fluid path.
| G-REX®100M-CS | Gen1 | Gen2 | Same or Improved? |
|---|---|---|---|
| Product REF Number | 81100-CS | G281100-CS | – |
| Availability | Current | August 2026 | – |
| Device Specifications | |||
| Height | 7.51 in (19.1cm) | 7.31 in (18.6cm) | – |
| Diameter | 5.26 in (13.4cm) | 5.26 in (13.4cm) | – |
| Approximate Dry Weight | 0.63 lbs (286g) | 0.708 lbs (321g) | – |
| Devices Per Package | 1 device | 1 device | Same |
| Minimum Shipping Quantity | 3-pack (case) | 3-pack (case) | Same |
| Case Dimensions (Length x Width x Height) |
L 20.5in (52.1cm) W 10.63in (27.0cm) H 5.88in (14.9cm) |
L 22.13in (56.2cm) W 12.13in (30.8cm) H 5.88in (14.9cm) |
Same |
| Shelf Life | 3 years | 3 years | Same |
| Body (shell) Material | Polycarbonate (Injection molded) | Same | |
| Membrane Specifications | |||
| Gas Permeable Membrane Surface Area | 100cm2 | Same | |
| Gas Permeable Membrane Material | Silicone Elastomer (USP Class VI, ISO 10993) |
Same | |
| Nominal Working Volume | 1000mL | Same | |
| Maximum Fluid Volume | 1100mL | Same | |
| Sterility & Biocompatibility | |||
| Viral Penetration Testing (Membrane Material Only) |
ASTM F1671 | Same | |
| Microbial Ingress Tested (Closed System Only) |
ASTM E3251 | Same | |
| No Chemical Additives Statement | G‑Rex® Products Do Not Use Latex, BPA, Phthalates, Nitrosamines, Residual Solvents, or Mold Release Agents in their Component Manufacturing or Final Device Assembly | Same | |
| Electronic Instructions for Use (eIFU) | www.wilsonwolf.com | Same | |
| Multi-Port Cap | |||
| The Multi-Port Cap represents a sophisticated evolution of our primary fluidic interface interface, replacing the original threaded design with a sleek, polycarbonate, snap-fit cap with bonded PVC tubing. This refined, snap-fit architecture creates an immutable closed & sterile seal between the cap, the tubing set, and the body (shell) of G-Rex®, removing the risk of a sterile fluid path breach. It is an elegant engineering solution that provides structural security, inherent to the device itself. | |||
| Shell Tubing Spud (Multi-Port Cap) Material | Polypropylene | Polycarbonate (Injection Molded) | Improved |
| Shell Tubing Spud (Multi-Port Cap) Design | Threaded Cap; can be removed from Body (shell); | Snap Fit; cannot be removed from Body (Shell); | Improved |
| Shell Tubing Spud (Multi-Port Cap) Tubing connections to ports | Silicone tubing pulled through ports in cap; connected to external PVC lines via barbed luer fittings | PVC tubing bonded directly to ports in the Shell Tubing Spud | Improved |
| Vent Filter | 0.2 μm Pall Versapor® Vent Filter | Sartopore Air Midisart, PES (0.2µm), 25mm | – |
| Fluid Management System | |||
| The Fluid Management System introduces a sophisticated dual-ring architecture that elegantly 'flosses' the tubing set into a curated, vertical column. By replacing loose, wrapped lines with this structured alignment, we’ve created a neater and more ergonomical solution for clinical and commercial manufacturing. This streamlined design simplifies and systematizes device set up and operation, bringing another layer of discpline to G-Rex® based CGT production. | |||
| Exterior Tubing Management System Design | Tubing is loose and wrapped inside packaging secured with a channel clip | Dual Ring Tubing Management System; tubing is tight and secured and available for use by operators | Improved |
| Exterior Tubing Management System Material | Polypropylene | Polycarbonate (Injection Molded) | Improved |
| Exterior Tubing Fitments | Polypropylene fittings bonded to PVC | No fittings. Tubing is sealed with no tubing fitments; Sample port is a luer | Improved |
| Exterior Tubing | PVC (red-stripe and clear); thermal weld compatible | Same | |
| Sample Port | MicroClave® Connector | Needleless Injection Site | Improved |
| Luer Connections | 4 connections | 1 connection (0 connections in sterile fluid path) |
Improved |
| Dead-End Luer Cap/Plug | Dual fitting; can be overlooked by end user | Removed, PVC tubing ends in seal. | Improved |
| Interior Tubing | Silicone Elastomer (USP Class VI, ISO 10993) |
Same | |
| Internal Cell Harvest Line Internal Reduction Line |
Not secured; possible to move out of position | Secured to sidewall of Body (shell) for consistent cell harvest | Improved |
| Membrane Support Base | Clear; poor contrast when observing cell growth | Black; good contrast when observing cell growth | Improved |
Approved. Adopted. Deployed at Scale.
From six commercially approved T-Cell therapies, including 2 leading FDA-approved CAR-T and TIL therapies, to deployment across 800+ organizations, G-Rex® bioreactor has an established manufacturing record.
G‑Rex® has been incorporated into the commercial manufacturing process for AMTAGVI® (lifileucel), an FDA-approved tumor-infiltrating lymphocyte (TIL) therapy and the first TIL therapy to receive U.S. FDA approval. This inclusion in a Biologics License Application (BLA)-approved manufacturing process reflects use of G‑Rex® within a process reviewed and approved by the agency. Source: Iovance Biotherapeutics SITC 2019
Academics
Stanford University
"Stanford's LCGM anticipates a need to support a greater number of clinical trials and the G-Rex Grant will be used to help meet that need," said Dr. Feldman.
Memorial Sloan Kettering Cancer Center
"The G-Rex Grant will expedite development and accelerate our entrance into human clinical trials," - Dr. Klebanoff.
Seattle Children's Hospital
"This technology has been a core component of our CAR-T platform for many years...using G-Rex bioreactors." - Christopher Brown (Seattle Children's Therapeutics)
Children’s Hospital LOS ANGELES
After extensive evaluation, we've identified the G-Rex system as the platform of choice for establishing an efficient, scalable, and cost-effective CAR-T manufacturing process that supports both my lab and our clients within the GMP facility." - Mohamed Abou-el-Enein M.D., Ph.D.
Children's National Hospital
"This effort reflects the importance of working together to move promising cell and gene therapies from the lab to the patients who need them most." - Dr. Hanley.
CIRM
"We applaud the CIRM awardees for securing G-Rex grants to further advance the development of cost-effective cell therapy manufacturing platforms for patients," - Dr. Shyam Patel, Associate Vice President of Preclinical Development at CIRM.
Start-Ups
BrainChild Bio
"G-Rex has been an essential element of our clinical CAR-T manufacturing program at Seattle Children's dating back to 2012." - Dr. Michael Jensen
March Biosciences
"...a robust cGMP process with the G-Rex bioreactor to further reduce complexity, time, and costs...with manufacturing autologous CAR-T products." - Dr. Maksim Mamonkin
Moonlight Bio
"We are grateful to receive a G-Rex Grant to support the advancement of our lead CAR T asset into the clinic in a platform that is cost effective and scalable." - Dr. Jordan Jarjour, Chief Scientific Officer at Moonlight Bio.
A2 Biotherapeutics
"We are very impressed by the simplicity and scalability of the G-Rex platform and look forward to exploring its applications in our clinical development programs." - Dr. Agi Hamburger
Verismo Therapeutics
"...transitioning our active and future pipeline to G-Rex®, ensuring we can deliver life-saving treatments...more efficiently and cost-effectively." - Raymonde Luke
Luminary Therapeutics
"The G-Rex Grant Program... will directly impact our ability to generate the clinically significant data we need to attract the investment required to advance the state of our γδ T cell pipeline," - Mr. Jeff Liter, CEO of Luminary Therapeutics.
Technical Questions Answered
MSAT • QC • PD
These are the most common questions we receive about the G‑Rex® bioreactor. Please contact a specialist to learn more.
Why were luer fittings removed from Gen2?
After gathering extensive feedback from hundreds of customers who have purchased thousands of G‑Rex® devices, the vast majority are not using leur connections in the process to add or remove fluid from the G‑Rex®. PVC tube welding has emerged as the standard sterile connection and the removal of leurs reflects this standardization. Removing leurs removes unnecessary parts, complexity, and risk from the device and from the process for a more operationally mature G‑Rex® user base.
How does the multiport cap on the Gen2 G‑Rex®100M-CS provide a more secure seal?
The multi-port cap represents a sophisticated evolution of our primary fluidic interface, replacing the original threaded design with a sleek, polycarbonate, snap-fit cap with bonded PVC tubing. This refined, snap-fit architecture creates an immutable closed & sterile seal between the cap, the tubing set, and the body (shell) of G-Rex®, removing the risk of a sterile fluid path breach. It is an elegant engineering solution that provides structural security, inherent to the device itself.
How does the Gen2 G‑Rex®100M-CS secure the pathway of the tubing set?
The Gen2 G‑Rex®100M-CS has improvements to both the exterior and interior tubing sets that secure the consumable's pathway for a more ergonomical, consistent, and repeatable experience.
The tubing management system introduces a sophisticated dual-ring architecture that elegantly 'flosses' the tubing set into a curated, vertical column. By replacing loose, wrapped lines with this structured alignment, we've created a neater and more ergonomical solution for clinical and commercial manufacturing. This streamlined design simplifies and systematizes device set up and operation, bringing another layer of discipline to G‑Rex® based CGT production.
Will Gen2 perform comparably to Gen1 in my process?
Because the Gen2 G‑Rex®100M-CS is built with the same core materials & device geometry and operators with the same core mechanics, the Gen2 G‑Rex®100M-CS will function comparability in your current process.
A comparability study from CellReady, our G‑Rex® centric CDMO, is available here and demonstrates consistent expansion across multiple donors when using both the Gen1 and Gen2 G‑Rex®100M-CS.
What documentation is available to support the transition from Gen1 G‑Rex®100M-CS to Gen2 G‑Rex®100M-CS?
Click here to download your Gen2 Transition Documentation Package that includes:
1) Instructions for Use
2) Technical Data Sheet
3) Certificate of Conformance
4) Validation Package
5) Comparability Study
6) Gen2 Features List
7) Risk Assessment
8) Impact Assessment
Is the Gen2 G‑Rex®100M-CS a fully closed system?
Yes, the Gen2 G‑Rex®100M-CS is validated to have a fully closed and sterile fluid path.
How does Wilson Wolf validate the closed and sterile nature of the G‑Rex®100M-CS sterile fluid path?
Sophisticated pressure decay testing is done on 100% of all fully assembled G‑Rex® bioreactors. After passing an extremely sensitive pressure decay testing, the device is gamma irradiated in its final packaging.
How does Gen2 reduce operator handling variability during manufacturing?
Gen2 G‑Rex®100M-CS reduces operator handling variability during manufacturing through improvements to the tubing set, namely through the dual-architecture Tubing Management System and the stabilization of the internal volume reduction and cell harvest tubes.
Have a different question? Contact a G-Rex® Specialist.
Documentation
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ScaleReady specialists are trained specifically to support teams through migration, change control and upgrades with G‑Rex®. Connect with a ScaleReady specialist to talk through the specifics of your situation and learn how Gen2 G‑Rex®100M-CS can optimize your process.