Cells that save lives are valuable! Cells that alleviate pain and suffering in millions of people are valuable!
Closed Cytocentric approach delivers the promise of cell therapy faster, at less cost, with less risk, and better outcomes than conventional open methods!
Cell Therapy has Potential to Cure Diseases that Affect Millions Worldwide
|Cancer: 7.4 million Deaths/Yr.
Diabetes: 220 Million Worldwide
Epilepsy: 50 Million Worldwide
Parkinson’s: 4+ Million
Heart Attack & Stroke: 16 Million Deaths/Yr.
Sickle Cell Anemia: 2+ Million
Blindness: 45 Million Worldwide
Deafness: 70 Million
Cystic Fibrosis: 70 Thousand
Multiple Sclerosis: 2.1 Million
Alzheimer’s: 18 Million
|World Health Organization|
For the first time in the history of medicine, there is now hope for millions of people with intractable disease and injury. New therapies based on the natural developmental ability of cells to regenerate and heal and fight disease are on the horizon. Amazing stories of success in pre-clinical animal models are reported almost every day. We all know it’s only a matter of time before these get refined and move into the clinic. If these are your cells, you will positively impact the lives of a lot of people!
Not only will these new cell therapies save lives and alleviate pain and suffering in huge patient populations, but they are also expected to save the taxpayer trillions of dollars. That’s why national and state governments worldwide are pouring billions of dollars into the research to develop these new cell therapies. The California $3 Billion Stem Cell initiative may be the most famous, but it’s only one of many. Private investments are also rising rapidly. Now even big pharma is jumping in. The promise is too big to ignore!
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 clean rooms 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.
|Culture and process clinical grade cells in the lab|
Challenges are many in the development and delivery of new cell therapies, but the Cytocentric approach offers huge advantages, in all stages of development, to all parties involved. Meeting the needs of the cells seems simple, but it’s the key. Compared to the conventional open People-Centric approach, the closed Cytocentric approach will:
– save millions of dollars
– shave years off the development cycle
– reduce risks across the board
– produce a better cell product
If you are working with cells in the cell therapy arena, even upgrading conventional people-centric equipment with cytocentric features is not enough. The practical and strategic advantages of the full cytocentric-by-design Xvivo GMP System® are too compelling… in all phases of development.
The Xvivo GMP System® is the subset of our Cytocentric Platform designed for GMP compliant cell processing and production. It is not addressed in detail on this website, only in a general overview of its’ significant role in cell therapy on this page. For more information on the GMP compliant Xvivo System® model X2 go to the BioSpherix Medical website.
Complete isolation of the cells from contamination
Closed system for uninteruptible optimal conditions throughout your entire system
Cell Therapy Development Cycle
|The path from basic research to commercial rollout is quicker, less risky, and will cost millions less with the Xvivo System®|
BASIC RESEARCH PHASE
The discovery phase. Takes place in typical labs growing and handling cells, cell cultures, doing cell research, discovering cells that have potential, ones that look like viable candidates for further development. A candidate emerges when a cell shows potential, a rationale exists, and some type of evidence of therapeutic mechanism, whether a molecular assay, a cell assay, an animal assay. Learn not only how the raw power of the Xvivo System® model X2 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. Once a potential candidate emerges, there are many big decisions to be made. Risk is a factor in each. 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. Bricks-and-mortar means huge investments, long lead times, and risks that are barely manageable by even the best-run, best-funded large organizations. Learn how Xvivo System® model X2 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 at break-neck speeds, and makes it much easier and faster to regulatory approval. Reduce Your Risks in Translational Research With Cytocentricity…
First into humans. GMP compliance required by regulatory agencies to assure quality product. Must have validated production process using validated equipment in validated facility. Conventional people-centric “bricks-and-mortar” cleanroom slows clinical trials and is less likely to lead to a successful therapy. Learn how Xvivo System® model X2 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…
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 conventional bricks-and-mortar cleanrooms make commercialization a challenge, but the cytocentric approach is different. Learn how the Xvivo System® model X2 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…
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. Is it a coincidence or is it just common sense? The essence of GMP is quality and if you consider cells as a product, cytocentricity makes sense. 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 Principles. Learn just how closely aligned Cytocentricity and GMP are, and even how Cytocentricity raises the bar.
Can anyone ever make any money with cell therapy? Two diametrically opposite business models are proposed. Both have doubters. The traditional big pharma business model is where the cell is a uniform product mass produced in a huge centralized GMP compliant factory and then shipped out frozen in vials to clinics worldwide, then stored in freezers on-site until administered to the patient when needed. Many worry about the compatibility and utility of an allogeneic cell. The alternative clinic based business model using patient specific GMP compliant cell and tissue processing in the clinic near the patient is the other business model. Doubters here worry about the high cost. But the drive for cures is so strong that both models are probably viable. Certainly both models are actively being pursued. Obviously the Xvivo System® model X2 is perfect for patient specific production in the clinic, but even the mass production model if successful has that final processing point where it may also play a key enabling role in the final thawing and washing and prepping of the cells before they go into the patient.
Xvivo System: Tool of choice for development and delivery
of these new cell therapies.
Isolator Preferred Technology…
|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 Cleanroom technology may not be considered viable for new facilities in the near future.|
|Francis, L. Pharmaceutical Engineering, May/ June 2007, Vol.27, No. 3|
Cell therapy is the next evolution of medical treatments. It offers the promise of huge benefits for millions of people with currently untreatable diseases and devastating injuries. What truly differentiates cell science from molecular therapeutics is the innate characteristic of cells to grow, differentiate, seed and integrate naturally into tissue, develop, heal, battle infection, etc. which all have potential to provide a cure for failing and impaired cells and tissues. Cell and gene therapy and regenerative medicine are revolutionary approaches that actually may cure afflictions as opposed to treating them. The challenge is to consistently produce and safely deliver these therapeutic cells. The best tools maximize the odds that you and your cells can do it !