Cytocentric & GMP

Xvivo GMP System as a platform technology…

By definition, platform technology is used to describe a technology that supports development through the creation of products/processes without the continual expenses of new processes or technologies….

Cytocentricity aligns naturally with regulatory compliance!

Challenges are many, but the reliable production of clinical grade cells is easier when you meet the needs of the cells. The essence of GMP is quality. A quality cell product is more assured if you protect from contamination, avoid suboptimal conditions, optimize cell parameters, simulate physiologic cell requirements, keep up with changing culture requirements, and all the other cytocentric criteria. 

Examples of recent industry and regulatory feedback:

"Current cGMP guidelines from the US FDA as well as comments from FDA personnel indicate an increasing regulatory preference for advanced aseptic processing, specifically isolators for future facilities. As a result, standard clean room technology may not be considered viable for new facilities in the near future."  **(Francis, L. Pharmaceutical Engineering, May/ June 2007, Vol.27, No. 3)

"The guidance underscores the advantages that automation and isolation concepts offer in protecting the exposed sterile drug product during its aseptic manufacture." ** (FDA's Guidance for Industry - Sterile Drug Products; Produced by Aseptic Processing cGMP)

"The flexibility in these cGMP regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement." (www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm)

"Systems that promote greater product and process understanding can provide a high assurance of quality on every batch and provide alternative, effective mechanisms to demonstrate validation." ** (FDA's Guidance for Industry:  PAT - A framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; Sept. 2004)

Closed Cytocentric approach delivers the promise of cell therapy faster, at less cost, with less risk, and better outcomes than conventional open methods!

Conventional "People-Centric" approach inhibits progress

Growing and processing cells in open incubators and open hoods is so prone to contamination risk that the regulatory agencies demand cell production be performed in GMP facilities (cleanrooms, isolators, etc) to achieve clinical grade cells. Cleanrooms are costly, take a long time to plan, take a long time to build, take a lot of space, impose many operational and financial risks, and still leave people in the same space as the cells. Handicaps inherent in conventional open people-centric equipment impedes progress. Discover how the Cytocentric approach is a practical, economical, and superior alternative.

  • • save millions of dollars

  • • shave years off the development cycle

  • • reduce risks across the board

  • • produce a better cell product

 

Xvivo GMP System Lays Foundation for Fast-Track Development Cycle

Basic Research Phase

The discovery phase.  Learn not only how the Xvivo System gives you the ability to develop more and better cell candidates in all the obvious ways, but also the non-obvious strategic advantage of how it can lay a foundation for you early that will position you favorably for a fast track through the next and later stages in the development cycle. Develop Better Cell Candidates in Less Time With a Cytocentric Philosophy to Basic Research...

Translational Research Phase

The bench-to-bedside transition phase. In order to get regulatory approval to go into humans you have to prove (1) that you have a good rationale, and (2) that you can reliably produce the cells. A conventional people-centric approach ties you to the big 'bricks-and-mortar' cleanroom issue. The Xvivo System provides a low risk low cost pay-as-you-go approach, manageable even by small labs. Cytocentric-By-Design removes the bottleneck at this stage of the development cycle, and makes it much easier and faster to obtain regulatory approval. Reduce Your Risks in Translational Research With Cytocentricity...

Clinical Trials

First into humans. GMP compliance is required by regulatory agencies to assure quality product with a validated production process using validated equipment in a validated facility. Conventional cleanrooms slows clinical trials and is less likely to lead to a successful therapy. The Xvivo GMP System speeds up clinical trials, easily accommodates the same clinical trial in multiple locations, scales precisely, eliminates tech transfer risks, eliminates financial surprises, provides the only PAT compliant platform for continuous improvement and parametric release of product, and produces a higher quality product than ever possible in open incubators and open hoods in open cleanrooms. Clinical Trials Are More Scalable With a Cytocentric Approach...

Commercial Rollout

Surprisingly most aspiring cell therapists have not thought through to this end stage. What if your clinical trials are a resounding success? What if your new cell therapy is safe and actually cures a dreadful disease or injury? What if you get a license to sell it? How are you going to roll it out to clinics worldwide? The extremely large costs and slow deployment and inflexibilities of cleanrooms make commercialization a challenge, but the cytocentric approach is different. The Xvivo GMP System may be the perfect vehicle for commercial success. It may be the only way to quickly execute roll out, and maintain complete control over the quality of the therapy and the revenue stream. Cytocentrics Can Maintain Consistency and Quality With Your Commercial Rollout...