What We Offer

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Better Quality

Quality means two things. First it means a highly reproducible and consistent end-product.  Second it means a product free of microbial and particulate contaminants. Complete isolation between the cells in an aseptic environment and the contaminated world outside maximizes quality. The Xvivo System was designed for GMP from the start. 

With features such as real-time monitoring, alarming, and documentation of bio-burden, airborne particulates, vapors, and batch process variables, each culture/process can be routinely documented for quality auditing. Creating an audit trail is easy with full time data logs of conditions from start to finish as well as allowing for validation of process improvement steps instead of re-validating the whole process.

User access with electronic records and signatures in compliance with FDA 21CFR Part 11 can be designed in from the start or added later. 

 

 

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Modular Design

Its flexible design adds to the value as a quality investment. The Xvivo GMP System can accommodate different processes to evolve with your research. It can be moved to different locations and adapted to virtually any existing space

Unlike brick-and-mortar cleanrooms, scale now for just what you know you will need next. Scale up later only if needed. Avoid the risk of scaling too high or too low, which is a common risk with cleanrooms. Add to same Xvivo System used in R&D. 

Develop and validate production process in any lab or unclassified space, there is no big investment required for a new facility. The entire Xvivo GMP System can be redeployed to move from lab to lab, building to building, city to city, country to country as the need arises with no loss of momentum. 

 

 

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Better Cell Product

A tightly controlled and reproducible production process is the formula for consistent high quality cell product. The Xvivo GMP System is the only commercially available incubation system designed for uninterrupted conditions. Cultures are never exposed to ambient room conditions like they are in cleanrooms and other isolators. They experience none of the suboptimal transients that normally occur between the incubator and the hood, or between the incubator and the microscope, or between the hood and the centrifuge, all of which can cause variations in the cells. Unprecedented new features, unachievable in traditional brick-and-mortar clean rooms, produce a superior product.

 

 

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Reduce Risk

The unique ability to produce clinical grade cells anywhere at any stage of the development cycle, allows you to generate your pre-clinical data with the same cells you propose to use in humans. 

With the Xvivo System, GMP compliance is fast and easy. No long waits. No tech transfer risks. No huge investments. No new SOPs. No new process validation procedures. No new facility validation procedures. No loss in continuity of PAT audit trail. No difference in cells.

 

 

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Better Process Control

By enclosing all processes inside the Xvivo GMP System it is much easier to control what enters a small isolation cabinet compared to what can enter into a big walk-in clean room. The better the control over those variables in the manufacturing space, the better the GMP.

Offering high performance dynamic control of multiple variables simultaneously (O2, CO2, NO, CO, and temperature), the Xvivo GMP System can help you develop your conditioning protocols. You can program it to automatically change any variable, or all variables, any time you want. 

With multiple independent incubation chambers, the Xvivo GMP System allows many cultures to be processed simultaneously. Each dedicated and integrated chamber is programmable to control different conditions without affecting any other cultures. This greatly minimizes the chance of cross contamination or culture “mix ups”. Incubators, hoods, and clean benches are integrated into the system with all incubation chambers opening directly into the “closed hood”, eliminating the risk of interruption.

 

 

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Save Money, Time and Space

Small cleanrooms can cost 200-300k to operate each year. By shrinking the aseptic real estate down to “as-small-as-possible”, the Xvivo GMP System operating costs are a lot less, generally 10% of traditional cleanroom costs. This savings quickly adds up and customers say their Xvivo GMP system pays for itself in a very short time. 

Implementation is fast. Prefabricated modules can be assembled and installed quickly. Qualifications and validations are straight forward and assured. GMP compliance can be achieved faster than ever before. Implementation is measured in a couple months, instead of years. 

For our pre-GMP customers, once they are approved to move to clinical trial, there is no big delay. Simply move to or surround the system with a Class 100,000 free standing clean zone in a restricted access room. No new SOPs. No new validation procedures. No long wait to secure a future cleanroom suite or the enormous expense of renting a cleanroom.

 

 

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Better Contamination Control

The number one source of contamination in any lab are humans. The Xvivo GMP System totally isolates the product inside an aseptic “mini-environment”. The product is never exposed to the room, and more importantly, never exposed to the people in the room. A closed system offers better security against contamination than any walk-in cleanroom ever could. It is always going to be considered a better GMP to have cells totally isolated from technicians than to have cells in the same space as technicians.