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News Article | May 25, 2017
Site: www.businesswire.com

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "South Korea Market Report for Pulse Oximetry 2017 - MedCore" report to their offering. The market for peripheral pulse oximetry includes stand-alone bedside, handheld and fingertip monitors, as well as reusable and disposable sensors and OEM device boards. Elements from the venous and tissue saturation markets are not explored in the scope of this report. The market for pulse oximetry sensors represented the majority of the total market. Growth in the total market will primarily be driven by high volumes of disposable sensors and growth in the OEM circuit devices. With the exception of the fingertip segment, the pulse oximetry monitor market is mature and sales are largely made on a replacement-basis. Sensor sales will increase primarily with the growing incidence of disease and hospitals admission rates, driven in part by the growing percentage of individuals over the age of 65. There continues to be a strong push for more monitoring in both hospitals (unmonitored wards and medical surgery) and alternate care settings (long-term care facilities and skilled nursing facilities). Both disposable and reusable segments will be able to take advantage of the anticipated growth, although competition between vendors will be significant. Additionally, although not discussed separately herein, the retail market for non KFDA-approved pulse oximetry devices continues to grow as the customers look to take proactive action to better manage their health or chronic conditions. While pulse oximetry equipment is already widely used in hospitals, the market is still expected to grow substantially due to the introduction of new technologies, and the expanding use of sophisticated multi-parameter monitoring devices. As these multi-parameter monitoring devices almost always include pulse oximetry as one of their capabilities, they account for the bulk of pulse oximetry procedures performed in hospitals. For more information about this report visit http://www.researchandmarkets.com/research/rv7d6n/south_korea


Mr. Hauck is currently the Executive Director of The Getz Group, a privately owned pan-Asian trading company focused on healthcare, industrial products, consumer distribution and retailing. He previously held executive and director level positions at various companies including, ERM, Interpharma Investments Ltd, Invida Holdings, Target Worldwide Express, 3i plc, Springboard, and Business Health Group Ltd. Mr. Hauck also served as the CEO of Walsh International for eight years, where he led the company's IPO and eventual sale to IMS Health. Mr. Hauck commented, "I am delighted to be a part of Integrity Applications, which is changing the way glucose is monitored and diabetes is managed. I am excited about the prospects for the company's innovative non-invasive glucose monitoring technology, GlucoTrack, to transform diabetes management, but especially the potential to expand its offering to provide valuable data and insights to healthcare professionals. I look forward to working with the Integrity Applications team as the company continues its expansion." About GlucoTrack® GlucoTrack® is a truly non-invasive monitoring device that rapidly measures and displays an individual's glucose level in about a minute without finger pricking or any pain. GlucoTrack® features a small sensor that clips to the earlobe and measures the user's glucose level using innovative and patented sensor technology. The measured signals are analyzed using a proprietary algorithm and then a calculated glucose level is displayed on a small handheld device the size of a small mobile phone. The glucose results are stored in the device and used for a projected HbA1c level using a proprietary algorithm. The device also displays the glucose values graphically allowing the user to monitor glucose over a period of time. GlucoTrack® has received CE Mark and KFDA approvals for type 2 diabetes and prediabetics, and is currently in the early stages of commercialization in Europe, South Korea and other geographies. GlucoTrack® is expected to begin clinical trials for United States FDA approval in late 2017. The product is currently experimental in the United States and is limited to investigational use only. About Integrity Applications, Inc. Integrity Applications was founded in 2001 and is focused on the design, development and commercialization of non-invasive glucose monitoring technologies for patients with diabetes and prediabetes. The company has developed GlucoTrack®, a proprietary non-invasive glucose monitoring device designed to obtain glucose level measurements in about a minute without the pain, incremental cost, difficulty or discomfort of conventional invasive finger stick devices. Integrity Applications Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Ashdod, Israel. For more information, please visit www.integrity-app.com and www.glucotrack.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "expect", "plan" and "will" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect Integrity Applications' actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Integrity Applications' results include, but are not limited to, the ability of Integrity Applications to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Integrity Applications' filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the SEC on March 30, 2017. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/integrity-applications-glucotrack-innovator-expands-board-of-directors-with-the-appointment-of-michael-hauck-300463739.html


For more information, please visit the company website at www.integrity-app.com. About GlucoTrack® GlucoTrack® is a truly non-invasive monitoring device that rapidly measures and displays an individual's glucose level without finger pricking or any pain. GlucoTrack® features a small sensor that clips to the earlobe and measures the user's glucose level using innovative and patented sensor technology. The measured signals are analyzed using a proprietary algorithm and then a calculated glucose level is displayed on a small handheld device the size of a small mobile phone. The derived glucose measurements are stored in the device and calculates a projected HbA1c level using a validated algorithm. The device also displays the glucose values graphically allowing the user to monitor glucose over a period of time. GlucoTrack® has received CE Mark and KFDA approvals for type 2 diabetes and prediabetics, and is currently in the early stages of commercialization in Europe, South Korea and other geographies. GlucoTrack® is expected to begin clinical trials for United States FDA approval in late 2017. The product is currently experimental in the United States and is limited to investigational use only. About Integrity Applications, Inc. Integrity Applications was founded in 2001 and is focused on the design, development and commercialization of non-invasive glucose monitoring technologies for patients with diabetes and pre-diabetes. The company has developed GlucoTrack®, a proprietary noninvasive glucose monitoring device designed to obtain glucose level measurements in about a minute without the pain, incremental cost, difficulty or discomfort of conventional invasive finger stick devices. Integrity Applications Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Ashdod, Israel. For more information, please visit www.integrity-app.com and www.glucotrack.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "expect", "plan" and "will" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect Integrity Applications' actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Integrity Applications' results include, but are not limited to, the ability of Integrity Applications to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Integrity Applications' filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the SEC on March 30, 2017. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/integrity-applications-to-present-glucotrack-data-at-american-diabetes-associations-77th-scientific-sessions-300462076.html


Sohn S.-J.,Duksung Womens University | Kim S.Y.,Duksung Womens University | Kim H.S.,Pusan National University | Chun Y.-J.,Chung - Ang University | And 3 more authors.
Toxicology Letters | Year: 2013

The non-animal in vitro test methods, especially for assessment of kidney toxicity, have become invaluable tools due to the target organ-selective nature of many nephrotoxic xenobiotics. In vitro evaluation of biomarkers for nephrotoxicity assessment using human cell lines, which can provide more reliable information for toxicological risk evaluation in humans than animal cells, has not been well established to date. The present study investigated the potential use of biomarkers for cisplatin-induced nephrotoxicity assessment in vitro using HK-2 cells derived from human kidney proximal tubule epithelial cells. Cisplatin induced apoptosis of HK-2 cells in which down-regulation of Bcl-2 and activation of caspase-3 were possibly involved. We investigated the effect of cisplatin on the protein levels of kidney injury molecule (KIM)-1, clusterin, calbindin, tissue inhibitor of metalloproteinase (TIMP)-1, cystatin C (CysC), β2-microglobulin (β2-M) and neutrophil gelatinase associated lipocalin (NGAL), which have been recently identified as in vivo biomarkers of nephrotoxicity. The protein levels of KIM-1, calbindin and TIMP-1 were significantly increased in the conditioned media of HK-2 cells treated with cisplatin, while β2-M, CysC, NGAL and clusterin were not affected by cisplatin treatment. The mRNA levels of KIM-1, calbindin and TIMP-1 were increased by cisplatin, indicating that cisplatin-induced up-regulation involves transcriptional activation. The levels of KIM-1, calbindin and TIMP-1 were significantly increased in urine of cisplatin-treated rats, providing in vivo validation of the in vitro results. Taken together, our results clearly demonstrate that among the known in vivo nephrotoxic biomarkers, KIM-1, calbindin and TIMP-1 can be effectively used as in vitro biomarkers for cisplatin-induced nephrotoxicity using a HK-2 human kidney cell system. © 2012 Elsevier Ireland Ltd.


Yoo H.-D.,Chonnam National University | Lee S.-N.,Chonnam National University | Kang H.-A.,CJ Cheiljedang Corporation | Cho H.-Y.,KFDA | And 2 more authors.
British Journal of Pharmacology | Year: 2011

BACKGROUND AND PURPOSE The objective of this study was to investigate the combined influence of genetic polymorphisms in ABCB1 and CYP2D6 genes on risperidone pharmacokinetics. EXPERIMENTAL APPROACH Seventy-two healthy Korean volunteers receiving a single oral dose of 2 mg risperidone were included in this study. KEY RESULTS Significant differences were observed between the ABCB1 3435C>T genotypes for the pharmacokinetic parameters (peak serum concentration) of risperidone and the active moiety (risperidone and its main metabolite, 9-hydroxyrisperidone). There were no significant differences in the area under the serum concentration-time curves of risperidone and the active moiety among the ABCB1 2677G>T/A and 3435C>T genotypes. However, the peak serum concentration and area under the serum concentration-time curves were significantly different among the ABCB1 3435C>T genotypes in CYP2D6*10/*10. CONCLUSIONS AND IMPLICATIONS These findings indicate that polymorphisms of ABCB1 3435C>T in individuals with CYP2D6*10/ *10, which has low metabolic activity, could play an important role in the potential adverse effects or toxicity of risperidone. © 2011 The British Pharmacological Society.


Research and Markets has announced the addition of the "Global Orphan Drug Clinical Pipeline Insight 2022" drug pipelines to their offering. Global Orphan Drug Clinical Pipeline Insight 2022 report gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase. As of 2016, almost 30 million people in the U.S. and 350 million people worldwide suffer from rare ailments known as Orphan Diseases. The name comes from the treatment meted out for such diseases, wherein the pharma industry was reluctant to develop drugs for such illnesses due to their economic unviability. Elaborating the concept, a rare disease or orphan diseases are the one's which affects only a small population. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. Consequently, in earlier times such truncated prevailed diseases were least attractive to the researchers and the investors. Previously, the market for orphan drugs was not as lucrative as it is today. Nevertheless, the Scenario has changed after the Orphan Drug Act (ODA), 1983 was passed in United States and later various countries enacted similar laws. The number of requests for orphan drug designation received by FDA's Office of Orphan Products Development (OOPD) has grown dramatically in recent years and is prompting FDA to adjust its timeframes for reviewing orphan drug designations in order to meet the demand. 2. Global Orphan Drug Designation Criteria 2.1 US Food and Drug Administration (US FDA) 2.2 European Medicines Agency (EMA) 2.3 Japan 2.4 Taiwan 2.5 Korean Food and Drug Administration (KFDA) 2.6 Australia 16. Discontinued & Suspended Orphan Drugs in Clinical Pipeline by Company, Indication & Phase 16.1 No Development Reported 16.2 Discontinued 16.3 Preregistration Submission Withdrawal 16.4 Marketed Withdrawal 16.5 Suspended For more information about this drug pipelines report visit http://www.researchandmarkets.com/research/25h929/global_orphan


Dublin, Dec. 15, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Orphan Drug Clinical Pipeline Insight 2022" drug pipelines to their offering. Global Orphan Drug Clinical Pipeline Insight 2022 report gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase. As of 2016, almost 30 million people in the U.S. and 350 million people worldwide suffer from rare ailments known as Orphan Diseases. The name comes from the treatment meted out for such diseases, wherein the pharma industry was reluctant to develop drugs for such illnesses due to their economic unviability. Elaborating the concept, a rare disease or orphan diseases are the one's which affects only a small population. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. Consequently, in earlier times such truncated prevailed diseases were least attractive to the researchers and the investors. Previously, the market for orphan drugs was not as lucrative as it is today. Nevertheless, the Scenario has changed after the Orphan Drug Act (ODA), 1983 was passed in United States and later various countries enacted similar laws. The number of requests for orphan drug designation received by FDA's Office of Orphan Products Development (OOPD) has grown dramatically in recent years and is prompting FDA to adjust its timeframes for reviewing orphan drug designations in order to meet the demand. Key Topics Covered: 1. Global Orphan Drug Market Overview 1.1 Market Overview 1.2 Global Orphan Drug Clinical Pipeline Overview 2. Global Orphan Drug Designation Criteria 2.1 US Food and Drug Administration (US FDA) 2.2 European Medicines Agency (EMA) 2.3 Japan 2.4 Taiwan 2.5 Korean Food and Drug Administration (KFDA) 2.6 Australia Global Orphan Drug Clinical Pipeline by Company, Indication & Phase 3. Orphan Drug Development Phase: Unknown 4. Orphan Drug Development Phase: Research 5. Orphan Drug Development Phase: Preclinical 6. Orphan Drug Development Phase: Clinical 7. Orphan Drug Development Phase: Phase-0 8. Orphan Drug Development Phase: Phase - I 9. Orphan Drug Development Phase: Phase - I/II 10. Orphan Drug Development Phase: Phase - II 11. Orphan Drug Development Phase: Phase - II/III 12. Orphan Drug Development Phase: Phase - III 13. Orphan Drug Development Phase: Preregistration 14. Orphan Drug Development Phase: Registered 15. Marketed Orphan Drug Clinical Insight by Company, Indication & Phase 16. Discontinued & Suspended Orphan Drugs in Clinical Pipeline by Company, Indication & Phase 16.1 No Development Reported 16.2 Discontinued 16.3 Preregistration Submission Withdrawal 16.4 Marketed Withdrawal 16.5 Suspended 17. Competitive Landscape 17.1 AOP Orphan 17.2 Agenus 17.3 Alexion 17.4 Bristol Myers Squibb 17.5 Biogen Idec 17.6 Celgene 17.7 Eli Lilly 17.8 Genethon 17.9 Genzyme Corporation 17.10 Glaxosmithkline 17.11 Merck 17.12 Novartis Pharmaceuticals 17.13 Orphan Europe 17.14 Pfizer 17.15 Prosensa 17.16 Rare Disease Therapeutics 17.17 Roche 17.18 Sanofi 17.19 Shire 17.20 Teva Pharmaceutical For more information about this drug pipelines report visit http://www.researchandmarkets.com/research/tk94d7/global_orphan


News Article | November 30, 2016
Site: marketersmedia.com

Since the landmark conclusion of the successful litigation defense to the imaginary patent infringement allegations filed by J&J, the company has focused its energies and resources towards the precise execution of its formal marketing plan. Several recent communications to its shareholders and the broader investment community were highlighted by the pursuit and completion of the initial phase of that Plan. Hundreds of on-line retail merchandising venues had been added and through which Gen family of test strip revenue had begun flowing. That successful tactical campaign continues to increase distribution point locations and expand individual location footprint. In anticipation of this accelerated demand, factory capacity has been increased by the Pennsylvania and the South Korea contract manufacturers to 620,000 GenUltimate! units per month. Concurrent to that on-line escalation, the company initiated the second chapter of its detailed Plan with the targeting and contracting of a global network of international distributors. That network remains in development and its conclusion is not shortly expected, however, initial progress has yielded short term positive accomplishments; two of which the company would like to share with its loyal shareholders: Both of these newly added international distributors will represent the company's GenUltimate!, GenSure! and GenChoice! product line in multiple nations. The agreement requires that each distributor maintain a local sub-distributor in each individual nation within their territorial exclusive. Keith Berman, PEO of Decision Diagnostics commented, "It is gratifying and highly appropriate that immediately following the Thanksgiving holiday we are in a position to update our shareholders and the entire investment community regarding the continuation of our efforts to execute our marketing plan, and to communicate the initial fruits of those tactical endeavors. We are all thankful for the loyalty of our investors and the support of our customers." The Company has contracted Uni-Care Corp to exclusively distribute the Gen family of test strips to the Republic of South Korea, China and the Philippines. Uni-Care has activated the arrangement with the submission of an initial stocking purchase order for approximately 40,000 pieces of GenUltimate! test strips to be shipped immediately following the product's registration with South Korea's KFDA regulatory agency, expected in early December. Additional stocking orders are expected from sub-distributors in China and the Philippines. The Uni-Care Exclusive Distribution Agreement requires the annual purchase of a minimum of 250,000 GenUltimate! units in the next 12 months. Macre Diagnostics S.R.L. has become the company's distributor to multiple countries in South America. Macre, located in Santa Cruz, Bolivia has secured its regulatory approvals and has placed an initial opening order for 10,800 pieces of GenUltimate! with a 12 month cumulative order for 2,850,000 pieces of GenUltimate! Mr. Berman continued, "Five years ago we committed to defeating J&J in the courts, regardless of the cost, in order to recapture our right to manufacture and sell our superior line of blood glucose test strips anywhere and to anyone without fear of interference or reprisal. That battle has ended and we were overwhelmingly victorious. We are now well into our new campaign targeting the global markets that supply the diabetic test strip to their ever-growing diabetic populations. The two newly contracted international distributor accounts that we have recently added to our network, and about which we are now communicating, is an impressive beginning. Our investors can expect to hear more similar conquests as we proceed into 2017." Forward-Looking Statements: This release contains the Company's forward-looking statements which are based on management's current expectations and assumptions as of November 29, 2016, regarding the Company's business and performance, its prospects, current factors, the economy and other future conditions and forecasts of future events, circumstances and results.


David Stegall Elected President of the Society of Risk Management Consultants The Society of Risk Management Consultants recently held their annual conference in Montreal, Quebec, Canada and elected new Officers and Directors. Birmingham, AL, November 01, 2016 --( Other Newly Elected Officers: President-Elect: Mr. Benjamin C. Few III, ARM, ARM-P, AAI, of Ben Few & Company, Fort Myers, FL; Secretary: Mr. Christopher J. Franki, CPCU, ARM, Vice President and Principal Consultant with Insurance Buyers’ Council, Inc. in Cockeysville, MD; Treasurer: Mr. Joe C. Underwood, ARM-E, CPCU, ACI, MBA, Principal at Albert Risk Management Consultants in Needham, MA and Immediate-Past President: Mr. Michael Norek, Principal Consultant and Partner at KFDA in Boston, MA. Newly Elected Directors: Ms. Joy M. Gänder, CPCU, ARM, Principal, Gänder Consulting, LLC in Madison, WI; Mr. Robert R. Duty, ARM, Senior Risk Consultant, Charles Taylor, PLC in Dallas, TX; Mr. Robert L. Bernens, ARM, President, Core Risk Services in Oldenburg, IN; and Mr. James R. Mahurin, CPCU, ARM, Principal, James R. Mahurin Risk Management & Insurance Consulting in Franklin, TN. Other Directors: Mr. Michael W. Gurval, ARM, of ICA Risk Management Associates in Stirling, NJ; Mr. Glenn Linville, CPCU, ARM, of CORE Risk Services in Cincinnati, OH; Ms. Noel Orsak of Sigma Risk Management Consulting of Houston, TX and Ms. Kelly Wierzchowski of Crain, Langer & Co. in Ritchfield, OH. The Society of Risk Management Consultants is an international organization of professionals engaged in risk management and insurance consulting. SRMC Members serve their clients and the public through research, education, exchange of information and the promotion of professional and ethical guidelines. SRMC Members are compensated exclusively by their clients on a fee-for-service basis and are held to rigid standards of education, experience, professionalism and code of ethics. For more information, contact: Chris Moss, Public Relations Chair - Society of Risk Management Consultants, christopher.moss@ctplc.com Birmingham, AL, November 01, 2016 --( PR.com )-- The Society of Risk Management Consultants ( srmcsociety.org ) is pleased to announce the election of Mr. David L. Stegall, CPCU, ARM, ARe, RPA to the position of President. Mr. Stegall is Principal Consultant at Risk Consulting & Expert Services ( www.rces.us ), a risk management and insurance consulting firm in Birmingham, AL. Mr. Stegall founded his firm in 2007 and holds a B.A. Degree in Communications from Auburn University.Other Newly Elected Officers: President-Elect: Mr. Benjamin C. Few III, ARM, ARM-P, AAI, of Ben Few & Company, Fort Myers, FL; Secretary: Mr. Christopher J. Franki, CPCU, ARM, Vice President and Principal Consultant with Insurance Buyers’ Council, Inc. in Cockeysville, MD; Treasurer: Mr. Joe C. Underwood, ARM-E, CPCU, ACI, MBA, Principal at Albert Risk Management Consultants in Needham, MA and Immediate-Past President: Mr. Michael Norek, Principal Consultant and Partner at KFDA in Boston, MA.Newly Elected Directors:Ms. Joy M. Gänder, CPCU, ARM, Principal, Gänder Consulting, LLC in Madison, WI; Mr. Robert R. Duty, ARM, Senior Risk Consultant, Charles Taylor, PLC in Dallas, TX; Mr. Robert L. Bernens, ARM, President, Core Risk Services in Oldenburg, IN; and Mr. James R. Mahurin, CPCU, ARM, Principal, James R. Mahurin Risk Management & Insurance Consulting in Franklin, TN.Other Directors:Mr. Michael W. Gurval, ARM, of ICA Risk Management Associates in Stirling, NJ; Mr. Glenn Linville, CPCU, ARM, of CORE Risk Services in Cincinnati, OH; Ms. Noel Orsak of Sigma Risk Management Consulting of Houston, TX and Ms. Kelly Wierzchowski of Crain, Langer & Co. in Ritchfield, OH.The Society of Risk Management Consultants is an international organization of professionals engaged in risk management and insurance consulting. SRMC Members serve their clients and the public through research, education, exchange of information and the promotion of professional and ethical guidelines. SRMC Members are compensated exclusively by their clients on a fee-for-service basis and are held to rigid standards of education, experience, professionalism and code of ethics.For more information, contact:Chris Moss, Public Relations Chair - Society of Risk Management Consultants, christopher.moss@ctplc.com David Stegall Elected President of the Society of Risk Management Consultants The Society of Risk Management Consultants (srmcsociety.org) is pleased to announce the election of Mr. David L. Stegall, CPCU, ARM, ARe, RPA to the position of President. Filename: SRMC-Press-Release-10-28-16Re.pdf Click here to view the list of recent Press Releases from Risk Consulting & Expert Services


News Article | April 21, 2016
Site: phys.org

Made by KIT: The microfluidic bioreactor technically reproduces plant tissue. The researchers now start a new project to make the next step. Credit: KIT Plants produce a number of substances that can be used to treat cancer, Alzheimer's or Parkinson's disease. Frequently, however, metabolic pathways to obtain the target substance are so complex that its biotechnological production is hardly effective and very expensive. Scientists of KIT now combine their expertise with the technical know-how of Phyton Biotech GmbH, the biggest producer of pharmaceutical ingredients with plant cells. With the help of a microfluidic bioreactor consisting of coupled modules, the scientists technically reproduce complex plant tissue to produce active substances against cancer or Alzheimer's disease more effectively and at lower costs. According to latest estimates, plants form about a million chemical substances, so-called secondary metabolites. Unlike amino acids or sugar, these secondary metabolites are not of vital importance. However, this vast pool of plant products contains a true treasure of pharmaceutically active substances that inhibit the growth of cancer cells or reduce the formation of Alzheimer-typical plaques in the brain. Many of these valuable ingredients cannot be produced synthetically. Often, they have to be extracted directly from wild plants and processed at high costs. Moreover, many of these plants are rare and endangered: For instance, the discovery of Taxol inhibiting cancer cells brought the Pacific yew to the brink of extermination. "For this reason, biotechnological approaches to producing the respective active substances are of high interest," Peter Nick, Professor for Molecular Cell Biology of KIT's Botanical Institute, says. Often, underlying metabolic pathways are highly complex. In the natural plant, the substance of interest mostly is the product of a long chain of steps with many converted interim products. The chemical processes required for this purpose do not necessarily take place in a single plant cell, but in several specialized cell types found in the plant tissue from the root to the leaf. Many years ago, Phyton demonstrated that plant-based medical substances, such as Taxol, can also be produced with minimum resources and sustainably by the cultivation of plant cells in the lab. "Certain substances, however, can be produced neither in a simple cell culture nor in microorganisms manipulated by genetic engineering, because metabolic pathways are too complex," Peter Nick says. "Within the framework of a new research project, we now want to technically reproduce plant tissue with various cell types using a so-called microfluidic bioreactor. It consists of several modules, in which one cell type each is cultivated. The modules are connected via channels. Metabolic products of one cell type then enter the next module for further processing without the different cell types being mixed. In the end, the target substance can be extracted from the flow and, hence, "harvested". The project is managed by the Jülich Project Management Agency (PtJ) and funded with EUR 750,000 by the Federal Ministry of Education and Research for a period of two years. The project partners are the Botanical Institute and the Institute of Microstructure Technology (both of KIT) and the company Phyton Biotech GmbH. Together, the three partners possess the expertise required for the project. The Botanical Institute contributes its knowledge of molecular cellular biology of plant cell cultures. Professor Andreas Guber and Dr. Ralf Ahrens of the Institute of Microstructure Technology are responsible for the development and fabrication of partial components of microfluidic bioreactors, their microassembly, and interconnection to a functioning system. The industry partner Phyton Biotech GmbH is a worldwide leading company in the area of plant cell fermentation and supplies the expertise and infrastructure needed to analyze potential applications on the industrial scale. "Cooperation with the experts of KIT will allow us to reach a new level of use of plant cells produced by controlled cultivation," Dr. Gilbert Gorr, Research and Development Director of Phyton, says. "Our joint objective is to make further natural substances accessible, which so far have been produced with large difficulties and high costs only." Phyton Biotech produces high-quality active pharmaceutical ingredients by plant cell fermentation (PCF) and is worldwide supplier of Paclitaxel and Docetaxel. The company has been inspected successfully by authorities, such as EDQM, EMA, FDA, KFDA, and TGA. Apart from production, Phyton also offers development services for customers. These cover the development of plant cell lines and fermentation processes for plant ingredients as well as the development of synthesis processes of complex substances. Explore further: Plant growth without light control: Synthetic photoreceptor stimulates germination and development

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