Commercially Available Biosensors Applications and Marketability Benjamin Babineau

Commercially Available Biosensors Applications and Marketability Benjamin Babineau Matthew Best Sean Farrell

Outline �Why This Project? �Background �Types of Biosensors �Applications �Commercially Available Biosensors �Marketability �Work Breakdown �Schedule �Resources

Why This Project? �There is a great need to create biosensors that are mass-producible �In the health field, it is imperative that the maximum amount of people have access to early warning diagnoses �This project will attempt to bring understanding as to why companies struggle with manufacturing biosensors on a large, inexpensive scale �By examining and employing effective methods that have been used to date, commercial biosensors can become more prolific

Background �What is a biosensor? �Analytical device for the detection of an analyte that combines a biological component with a physicochemical detector component �Components �Sensitive biological element �Transducer or detector element �Electronics and signal processors

Background �Detection Methods �Photometric � Optical biosensors use the phenomenon of surface plasmon resonance (SPR) � Surface plasmons are surface electromagnetic waves that propagate in direction parallel to metal/dielectric interface. � Excitation by light �Electrochemical � Electrochemical biosensors use a reaction that produces or consumes electrons

Background �Ion Channel Switch � Ion channel used to offer highly sensitive detection of target biological molecules �Piezoelectric � Uses crystals which undergo an elastic deformation when an electrical potential is applied � Detects changes in the resonance frequency �Other Methods � Thermometric � Magnetic

Types of Biosensors (Analytes) �Enzyme Electrode �Enzymes � Enzymes are immobilised on the surface of an electrode � Current is generated when enzyme catalyses �Immunosensor �Antibodies � Detects change in mass when antibody binds to antigen �DNA Sensor �DNA �Microbial Sensor �Microbial Cells

Types of Biosensors (Detection Mode) �Electrochemical �Potentiometric � Amperometric � Voltametric �Optical �Florescence � Adsorption � Reflection �Electrical �Surface conductivity � Electrolyte conductivity

Types of Biosensors (Detection Mode) �Mass sensitive �Resonant frequency of piezocrystals �Thermal �Heat of reaction �Heat of adsorption

Applications �Medical �Glucose monitoring in diabetes patients �Detection of pathogens �In-home medical analysis and diagnosis �Environmental �Detection of pesticides and water contaminates �Determining levels of toxic substances before and after bioremediation �Detection of metabolites such as molds �Remote sensing of airborne bacteria �Food Industry �Detection of drug residues, such as antibiotics and growth promoters, in food

Commercially Available Biosensors

Medical Industry �Home Blood Glucose Monitors Reli. On One. Touch Ultra Free. Style Lite Precision Xtra

Medical Industry �Home Blood Glucose Monitors (Continued) �Determines approximate concentration of glucose in the blood � Used mainly with people who have diabetes or hypoglycemia �How They Work � Today, most glucose monitors use an electrochemical method � Glucose in blood reacts with an enzyme electrode containing glucose oxidize � The enzyme is reoxidized with an excess of mediator reagent � The mediator is reoxidized by a reaction at the electrode and a current is created � The charge passing the electrode is proportional to glucose level

Medical Industry �i-STAT Portable Clinical Analyzer �Handheld blood analyzer system

Medical Industry �i-STAT (Continued) �Provides fast, accurate, and lab-quality results within minutes to accelerate decision making process � How It Works Uses Si in the sensor cartridge as a substrate and a conducting base; electronics are housed in the handheld device � Sensors are micro-fabricated thin film electrodes � Depending on particular assay the electrical signals produced are measured by the i-STAT’s amperometric, potentiometric, or conductometric circuits. �

Environmental Industry �In agricultural industry, enzyme biosensors are used to detect traces of organophosphates and carbamates from pesticides �One of the most successful commercial biosensors in industry is used in wastewater quality control �Biological oxygen demand analyzers �Though less lucrative than medical diagnostics, public concern and government funding is a large driving force for environmental biosensors �Measurement of pollutants and environmental hazards � Surface plasmon resonance (SPR) biosensors are most successful

Environmental Industry �ino. Lab BSB/BOD 740 �Wastewater control

Environmental Industry �ino. Lab BSB/BOD 740 �Laboratory dissolved oxygen meter for wastewater control �BOD is a parameter used to measure the quality of water and treatment results in wastewater � Developed for BODn measurements � Described in “Standard Methods for Examination of Water and Wastewater” �Management of up to 540 diluted samples �Up to 7 daily routines for dilution ratios

Food Industry �Quality is extremely important thus sound accurate biosensors are necessary �Enzyme-based biosensors are common in this industry �Measure amino acids, carbohydrates, gases, alcohols, and much more �Other commercially available biosensors include antibody-based and nucleic acid based biosensors �Mainly in trial and research laboratories �Expected to yield substantial returns in the future

Food Industry �Specific food markets that use biosensors include alcohol (wine and beer), yogurt, and soft drinks �Immunosensors are used to ensure food safety by detecting pathogens in fresh meat, poultry, and fish �In this particular market problems arise that limit use or effectiveness of biosensors �Need for sterility, frequent calibration, and analyte dilution

Niche Market �Zeo �Designed to analyze and improve sleep

Niche Market �Zeo (Continued) �Composed of a wireless headband, bedside display, online analytical tools, and emailbased personalized coaching program �Zeo will calculate your “ZQ”, a number that summarizes your sleep quality and quantity �Headband uses patent-pending Soft. Wave sensor to measure sleep patterns using the electrical signals naturally produced by the brain

Niche Market �bodybugg �Personal calorie management system

Niche Market �bodybugg (Continued) �Uses multiple physiological sensors for “sensor fusion” � Accelerometer � Tri-axis micro-electro mechanical sensor that measures motion � Heat Flux � Sensor that measures heat being dissipated by the body via a thermally resistant material � Galvanic Skin Response � Measures skin conductivity � Skin Temperature � Skin temperature measured using a thermistor-based sensor

Marketability

The Biosensor Market �The biosensor market is dominated by only a few products �For medical diagnostics, approximately 90% of biosensors are glucose monitors, blood gas monitors, and electrolyte or metabolite analyzers �Half of all biosensors produced worldwide are glucose monitors �Sales are projected at $1. 28 billion in the US in 2012 �The majority of the remaining market includes biosensors directed at environmental control, fermentation monitoring, alcohol testing, and food control

The Biosensor Market �The United States and Europe captured 68. 73% of the biosensor market in 2008 �Due to large development and manufacturing costs, devices tend to be specialized into areas the will receive the most response from the market �Miniaturization has reduced the price of the fabrication of the sensors �Makes products more marketable

The Biosensor Market �Home blood glucose monitors �The maturing of this particular biosensor have shown great insight into how the biosensor market works �Showed some hurdles/issues that must be examined for success � Robust interface – Direct 30/30 by Eli Lilly � Specificity – separate signal from analyte of interest from other signals � Stability – biological molecules can be housed long enough to gain valuable information

The Biosensor Market �Home blood glucose monitors (Cont. ) �This product, though extremely successful now, was not readily accepted initially � The market at the time, diabetic patients and physicians, was not the same as it is today � The devices were very primitive compared to what we see today � The manufacturing of the electromechanical strips were more difficult and expensive than expected �The market was dominated by larger companies which made it difficult for small players to get involved

Use in the Food Industry �There is an increasing demand for biosensors in the food industry �In the past little attention was given to using biosensors to examine food for pathogens �However, with a rise of incidents involving contaminated food there is now a need for a sensor that can accurately and quickly determine if food is contaminated �There are few sensors designed to do this now but this is a major field of new research

GTRI Food Safety Biosensor �Due to recent incidents with contaminated food validating food safety is becoming a major concern �The Georgia Tech Research Institute (GTRI) is currently testing a new food safety biosensor �This sensor uses integrated optics, immunoassay techniques, and surface chemistry to determine if there are pathogens present �It is capable of quickly identifying the species and concentration of various pathogens including E. coli and Salmonella

GTRI Food Safety Biosensor �This system is currently being testing in a metropolitan Atlanta food processing plant �This sensor allows early detection of pathogens which helps to keep contaminated food from reaching the market �These researchers hope that similar sensors might be used to identify other hazards within the food industry �If this sensor is proven successful it will be used as a model for the future development of sensors for the food industry

Techniques for Commercialization �Home blood glucose monitors �Have shown several keys to making competitive biosensors in the market � Limiting cost both to the manufacturer and consumer � Need for very high quality and accurate sensors � Especially in the medical industry where potentially life threatening illnesses are diagnosed � Understanding the end users needs � Sight impaired � Transparency in users life � Interface with a physicians work regime

Techniques for Commercialization �R&D of Commercial Sensors �R&D of commercial biosensors tends to focus on the creation of new sensors and the miniaturization of new sensors �Research takes place at both universities and private business �Because of the high cost to manufacture biosensors, miniaturization allows more sensors to be made with less material, energy, and effort �New research keeps companies and universities at the head of this quickly changing field

Techniques for Commercialization �Miniaturization �Need for analysis of a large number of assays � Cost efficient if small amounts of reagents are used �Allows for multi-analyte assays �Academic research � Duke University � Developed arrays of tiny electrodes that monitor heart electrical activity � Developed a single cm 2 chip with 400 individuallyaddressable microelectrodes used for special resolution of analyte distribution in small areas

Commercialization Issues �The commercialization of biosensors has lagged behind their research and development �There are significant costs and technical barriers that can slow down or block the commercialization of new systems �The amount of initial capital and technical knowledge that is required to start developing biosensors is so great that many new companies simply can not handle them

Commercialization Issues �Changes in manufacturing processes, automation, and miniaturization techniques mean that many biosensors are already obsolete when they are released �Customers are not willing to pay high prices of a product that is not the most advanced of its kind �As a result companies need to sink a large percentage of their budget into developing new technologies to stay competitive �If a company does not have enough capital to develop these technologies quickly enough, even if their product would normally be in high demand, they will not be successful

Market Development �The biosensor market is driven by market demand by the companies that produce sensors �This demand can come from the consumer (market pull) or it can come from the developer (technology push) �Push and pull have very different market strategies and they must be treated differently �Biosensors that are “pulled” directly by the consumer are generally more profitable and successful

Technology Push of Biosensors �Technology push deals with the development of biosensors that may not address a true user need �These products are developed by a company with the desire to create a market demand �Many commercial biosensors are designed with the idea that if they are available people will develop a need for them �Generally less successful and profitable until the product develops a need for its own distinct market

Market Pull of Biosensors �Market pull is generated by a true need for a product �Products that are necessary for the health and wellbeing of groups and individuals �These sensors tend to be related to medicine, safety, and biological sensing �Glucose sensors, pathogen detection, EKG sensors �This is currently the largest and most profitable area for the development and commercialization of biosensors

Trends in the Medical Industry �The medical industry demands biosensors that are fast, accurate, and noninvasive �Sensing time needs to be reduced while maintaining accuracy of the measurements �There is a growing demand for sensors that are internal instead of external to the body �Glucose sensors that are implantable so users are not required to pick their fingers several times every day

Work Breakdown �Ben �Research available commercial biosensors �Obtain technical information of these biosensors �Matt �Marketability of biosensors �Techniques used in industry �Sean �Miniaturization of biosensors � Techniques and benefits

Schedule �Gantt Chart Commercially Available Biosensors Week of 1 -Mar 8 -Mar 15 -Mar 22 -Mar 29 -Mar 5 -Apr 12 -Apr 19 -Apr 26 -Apr 3 -May Activity 10 -May Presentation 1 Report 1 Due Report 1 Review Due Report 2 Due Presentation 2 Report 2 Review Due Final Presentation Final Report Due Find Additional Commercial Biosensors Technical Information on Biosensors Marketability of Biosensors Availability of Biosensors

Resources �Fraunhofer-Gesellschaft. “Plastic chips monitor body functions, research suggests. ” Science. Daily 20 April 2010. 1 March �Jeffrey D. Newman, Anthony P. F. Turner. “Home Blood Glucose Biosensors: A Commercial Perspective” Biosensors and Bioelectronics, Volume 20, Issue 12, 20 th Anniversary of Biosensors and Bioelectronics, 15 June 2005, Pages 2435 -2453 �Reyes De Corcuera, Jose I. , and Cavalieri, Ralph P. "Biosensors. " Encyclopedia of Agricultural, Food, and Biological Engineering (2003): 119 -23. Print.

Resources �Kress-Rogers, Erika. Instrumentation and Sensors for the Food Industry. Ed. Christopher Brimelow. Oxford: Butterworth-Heinemann, 2001. Print. �Englehardt, Kirk J. "Food Safety Biosensor That Detects Pathogens Is Tested in Metro Atlanta Processing Plant. " Georgia Tech Research Institute: Industry Solutions 2010. Web. �Kuhn, Lance S. "Biosensors: Blockbuster or Bomb? " The Electrochemical Society (1998): 26 -31. Print.

Resources �Rodriguez-Mozaz, Sara, Maria-Pilar Marco, Maria J. Lopez De Alda, and Damia Barcelo. "Biosensors for Environmental Applications: Future Development Trends. " Pure and Applied Chemistry 76. 4 (2004): 72352. Print. �Various Internet Sources