Cells that predict drug efficacy and chemical toxicity are valuable!
Cell-based assays will provide information worth billions to the pharmaceutical, chemical, cosmetics, food, and insurance industries, ...and might save society trillions!
The number of analytic measurements that can be made on cells has grown tremendously. With technology ranging anywhere from fluorescence to impedance.
Cell-based assays have always been a powerful tool in the research lab. They are incredibly versatile. They can be designed to measure virtually any cellular or biochemical function. Use the right cells and the right markers, and you can get the right data. They are now rapidly moving out of the lab into industry and into the clinic.
INDUSTRIALIZED CELL-BASED ASSAYS
Cell-based assays are now attracting intense interest in the search for new drugs, and in the toxicity testing of new and old chemicals used throughout our modern world. Supercharge them with automation and high-throughput high-content analytics, and on the front end of the development cycle, cell-based assays can be used to screen huge numbers of compounds quickly with exquisite unprecedented sensitivity. On the back end of the development cycle, a promising compound can be exhaustively characterized by a huge variety of different assays, more thoroughly, more quickly, and more economically than ever before. Cytocentricity maximizes predictive accuracy and throughput of industrialized cell-based assays, and minimizes costs by assuring the quantity, quality, and consistency of cells needed, and the relevancy of the information generated.
The Challenge In Cell-Based Assays
INDIVIDUALIZED CELL-BASED ASSAYS
Cell-based assays have long been considered as possible diagnostic techniques. Personalize them for patient-specific use in the clinic, and cell-based assays may help physicians select the most effective therapy for each particular patient and avoid ineffective therapies. Cytocentricity maximizes predictive accuracy of individualized cell-based assays in personalized medicine, and makes regulatory compliance easy!
BETTER PREDICTIVE ACCURACY
MORE RELEVANT DATA - Better simulation of physiologic conditions provides more relevant data than non-physiologic conditions. Cytocentricity results in data that means something. Who knows what the data means when cells are produced or analyzed under non-physiologic conditions?
BETTER PHENOTYPE INTEGRITY - Better control of cell phenotype integrity allows better distinction between different organotypic cells. Cell types that require specific culture protocols are going to be more true and consistent when each of multiple protocols can be accommodated simultaneously.
MORE ROBUST CELLS - Cell based assays demand robust healthy cells, that can handle the rigors of relentless automated processing and analysis. When you attend to cell needs, you get more robust healthy cells, instead of weak and compromised even damaged cells when you disregard cell needs.
MORE ROBUST HEALTHY CELLS - They live and function longer in the dish. More data can be generated over a longer cell life cycle, and the quality of data remains higher longer.
FULL TIME OPTIMIZATION - Controlling cell parameters at optimal conditions not only during incubation but also during the processing and analytic procedures will allow longer more detailed multiple measurements without cell degradation.
Vioxx cost Merck $7 billion possibly more as additional class action suits are filed. To date 50,000 people have claims against the drug maker. Vioxx which was launched in 1999, brought Merck revenue of $2.5 billion at its peak in 2003 for a total of at least $11 billion. Vioxx was taken off the market on Sept 30, 2004.
Bextra, Pfizer's anti-arthritis medication, was taken off the market in 2005 under allegations that it caused heart attack, strokes, and skin diseases. In October 2008, Pfizer settled personal injury suit claims in the amount of $900 million.
LESS CONTAMINATION - Isolating the entire process in absolutely aseptic conditions increases throughput by preventing contaminations. From the original derivation of cells to the expansion and production of cells to the preparation of the assays and finally the analysis will be more reliable when protected from contaminations. No alternative provides better protection.
BETTER RESOLUTION - No random or regular exposures to known suboptimal conditions will increase throughput by reducing variation in cells. Smaller standard deviation means you need fewer data points to get the same answers. This requires less material, less labor, less overhead. More important, it takes less time. That means in the same amount of time you can run more assays. And you get the best data when you don't have to worry about fluctuations in viability-critical, and phenotypically-critical conditions. Assay reliability is adversely susceptible to culture fluctuations in temperature, humidity, O2, pH, and CO2 , which all conspire to cause, for example "the edge effect" in microplated cells, and other unexpected variations.
GMP/GTP/GLP QUALITY - Whether regulatory compliance is required or not, Quality-by-Design will generate on average less failure and therefore more throughput.
Redux (fenfluramine) fen phen removed from the market in 1997 causing heart valve disorders and pulmonary hypertension. American Home Products agreed to settle a class action lawsuit against them in 2000 for $12 billion.
Careless is... as careless does!
Much is now known about the negative effects of standard incubation practices on microplated cell cultures. Conventional "People-Centric" incubation and processing equipment is not designed to deliver the consistent environmental conditions cells need. Every time cells are removed from incubators for analysis, variations in the cell's environment cause variations in cell viability, cell phenotype, cell consistency. Worse, it can skew assay results. In the multibillion-dollar worlds of drug discovery and toxicity screening, that can cost dearly. The consequence of carelessness is lost or damaged lives. And the litigation that follows (see sidebars).
Xvivo System is Platform of Choice
The XVIVO System can enclose any cell production process big or small
Customized modules to fit any cell processing equipment
Full time optimization, full time protection, physiologic simulation, multi-protocol ready, from initial incubation to final assay readings is optimum for all cell based assays for reducing the variability by improving the control over environmental factors. Xvivo System provides the only cytocentric platform which allows you to integrate the entire chain: cell production via incubation and processing, preparation of assays, automation, imaging, and analytical equipment in fully closed isolated contaminant-free but accessible environment optimized for cells.
Leverage Cytocentric Discipline For Better Predictive Power
Cell-based assays will yield so much critical information that they will affect people worldwide as they play a larger role in the development and safety of our drugs and other products. The need for top quality consistent cells is key to assay effectiveness. Cytocentricity is at the very heart of uncompromised critical data.
Conventional "People-Centric" equipment can't deliver the predictive accuracy or the throughput, because it can't deliver the conditions cells need.