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James Thomson’s Cellular Dynamics Launches iCell Cardiomyocytes Commercially for Drug Candidate Toxicity Screening

Last Updated on Wednesday, 5 May 2010 11:52 Written by Editor Wednesday, 5 May 2010 11:52

The University of Wisconsin’s James Thomson, whose vision was behind the founding of Cellular Dynamics, has from the initial creation of Induced Pluripotent Stem Cells felt that their use in the testing of new drugs would mark their greatest contribution, at least initially.Thursday the company announced the commercial launch of iCell Cardiomyocytes for use in testing of new drug candidates by the pharmaceutical industry. These human heart cells are designed to aid drug discovery and improve the predictability of drug compound efficacy and toxicity screens, weeding out ineffective and potentially toxic compounds early in the pharmaceutical pipeline process before significant time and resources have been invested.

iCell Cardiomyocytes are the first product developed by anyone from iPS cells and were discovered by CDI senior research fellow Junying Yu, Ph.D., then a postdoctoral research associate in the University of Wisconsin-Madison laboratory of James Thomson.  Yu’s discovery followed a similar and almost simultaneous discovery by Shinya Yamanaka at Kyoto University.

Derived from induced pluripotent stem (iPS) cells, iCell Cardiomyocytes spontaneously beat in vitro and exhibit the electrophysiological and biochemical properties of normal human heart cells. Thus, both logically and according to Cellular Dynamics, iCell Cardiomyocytes provide significant advances over non-human cell models, which may exhibit a different response than human tissue. The same advantage is suggested to hold over tumor-derived cell models, which are genetically different than normal cells; and cadaveric cells, which exhibit batch-to-batch variability, de-differentiate under in vitro conditions, and exhibit non-cardiomyocyte behavior.

iCell Cardiomyocytes are produced in-house by Cellular Dynamics from a master cell bank of iPS cells expanded from a single clonal population reprogrammed from fully mature human cells using Dr. Thomson’s patented technology. Cellular Dynamics has reportedly developed a proprietary process to industrialize iCell Cardiomyocytes production so that the cardiomyocytes are manufactured at the high quantity, quality and purity required by pharmaceutical companies. The company has successfully engaged in pre-launch validation testing with several pharmaceutical customers.

James Thomson, chief scientific officer, had the following to say about the iCell launch: “Rapid application of stem cell technology has been a goal both of my laboratory at the University of Wisconsin and Cellular Dynamics. Utilizing human iPS cells for new drug toxicity testing should improve the drug discovery process in a timeframe that has an effect on human healthcare now, not 10 years from now. Ultimately applications of stem cell technology in drug discovery will provide great utility and enable movement toward a long-term goal of cellular-based therapeutics and personalized medicine.”

Adapted from the Cellular Dynamics announcement.

Source: stemcelldigest.net

Posted under Compound Screening, DNA Reasearch, Press Releases  |  No Comments

Tepnel Expands Genetic Services Portfolio with Addition of Illumina iScan Rapid Reader

Last Updated on Friday, 24 October 2008 10:36 Written by admin Friday, 24 October 2008 10:36

MANCHESTER, United Kingdom & STAMFORD, Conn.–Tepnel Life Sciences PLC (AIM:
TED) today announced that it has expanded its molecular genetic services
offering through the addition of Illumina’s iScan System, a next-generation
scanner that provides researchers conducting genetic variation studies with
significantly greater throughput and application diversity. This
announcement marks the first anniversary of Tepnel’s new pharmaceutical
services facility and makes Tepnel the first commercial provider of iScan
services within the UK.

Combined with Tepnel’s established range of upstream and downstream genetic
capabilities, the Company now offers a full suite of complementary services
from DNA extraction through to Bioinformatics. Illumina’s iScan platform
supports both human and non-human applications and is capable of generating
up to 225 million genotypes per day.

Tepnel also has a variety of other platforms and techniques for SNP-based
investigations for both human and non-human research and clinical
applications. This breadth of service enables Tepnel to provide a complete
solution from DNA extraction through to SNP genotyping and DNA sequencing,
all undertaken in accordance with Good Laboratory Practice (GLP).

“Tepnel can offer customers a broad portfolio of innovative genetic analysis
assays some of which are supported on our new high-throughput iScan reader,”
said David Scott, General Manager of Tepnel’s Livingston facility. “This new
addition to our service opens up the possibility to our customers of whole
genome association, focused content analysis, copy number variation analysis
and, epigenetics on both human and non-human samples, all within a
regulatory compliant environment.”

“Accelerating and expanding our molecular genetic services at this rapid
pace reflects our commitment to the long-term strategy of building Tepnel’s
market presence in the fast-growing sectors of
pharmacogenomics/pharmacogenetics and genetic disease disposition testing,”
said Allan Brown, Managing Director, Tepnel Research Products & Services.

About Tepnel Life Sciences plc

Tepnel Life Sciences (AIM:TED) is a UK-based international life sciences
products and services Group with two divisions, Molecular Diagnostics and
Research Products & Services. The Company has laboratories, manufacturing
and operations in the USA, UK and France with over 200 employees. Tepnel
provides test kits, reagents and services to two highly synergistic markets,
these being Molecular Diagnostics and Biomedical Research. The Company’s
strategy has been to identify high growth niche opportunities within these
multi-billion pound markets. Tepnel focuses on these niche operations with
internally developed products, patents, expertise and know-how as well as
strategic acquisitions, to develop a leadership position within these
defined market segments. For more information please visit www.tepnel.com.

Posted under BioInformatics, Clinical Trials, DNA Reasearch, Europe, Genetics & Pharmacogenetics, New Products, Press Releases  |  No Comments

BioServe Introduces Customizable DNA Panels for Genetic Research

Last Updated on Thursday, 11 September 2008 03:05 Written by admin Thursday, 11 September 2008 03:05

BELTSVILLE, MD — September 11, 2008 — BioServe today announced a more affordable pricing plan for its vast bank of DNA with comprehensive, de-identified, covariate data that includes age, gender, diet, body mass index (BMI), and race. In addition, each sample has data on the complete diagnostic and treatment history of the donor. BioServe’s DNA represents a wide range of disease states including cancers (breast, prostate, lung, colon, others), diabetes, heart disease, hypertension, arthritis, obesity, as well as some rarer diseases. The repository also includes over 14,000 control subjects that are free of major illnesses. DNA is available in quantities from a few nanograms to hundreds of micrograms per subject to suit customer needs. Customized DNA panels and case-control studies can be designed based upon the investigators’ needs, taking into consideration the specific data points available for each individual DNA sample. Another useful function of these DNAs is for investigators to utilize them as second group of samples to validate data generated from their studies.

“We are making high-quality DNA available at price points that are affordable to any research laboratory during these tough budgetary times,” stated Kevin Krenitsky MD, Chief Executive Officer of BioServe. “This will result in many more investigators who will be able to perform their research using very well annotated DNA samples. Experiments with these DNAs can be executed both in the investigators’ own lab, and/or at BioServe with a large variety of genomic platforms that are currently utilized. We also welcome collaborations that can make access even more affordable,” said Dr. Krenitsky.

BioServe’s DNA is obtained from human subjects that provided informed consent with strict IRB and HIPAA compliance. BioServe has obtained informed consent, detailed questionnaire data and DNA from over 120,000 subjects.

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests, promoting wellness around the world. BioServe offers the Global Repository®, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from more than 120,000 consented and de-identified patients from four continents. Leveraging BioServe’s robust genomic analytical services, processing technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly-efficient platform for obtaining diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

Posted under DNA Reasearch, North America, Press Releases  |  No Comments

Rentschler Biotechnologie Announces Cooperation with Boehringer Ingelheim

Last Updated on Wednesday, 21 May 2008 01:43 Written by admin Wednesday, 21 May 2008 01:43

Laupheim, Germany, Mai 21, 2008 – Rentschler Biotechnologie and Boehringer Ingelheim, both leading companies in biopharmaceutical development and production, have signed a preferred partnership agreement. The cooperation will enable Rentschler Biotechnologie’s clients to gain access to Boehringer Ingelheim’s large-scale mammalian biopharmaceutical production facilities in Biberach, Germany and vice versa, Boehringer Ingelheim’s clients to use Rentschler’s facilities of process development and intermediate-scale clinical supply production.

Through the cooperation clients from the pharmaceutical and the biotech industry will benefit from the combined development and manufacturing know-how and facilities, leading to increased flexibility and ultimately more customized services. Compatible bioprocessing methods guarantee a seamless project transfer between the companies which are conveniently located in close vicinity.

Rentschler Biotechnologie, a full-service contract manufacturer focused on process development and small to medium scale production of mammalian cell-derived biopharmaceuticals, currently operates eight independent GMP lines with fermenter volumes of up to 500 L. A 2,500 L has recently been qualified and is going to start operations. Boehringer Ingelheim, who offers similar services with technologies optimized for large scale industrial production, runs one of the world’s largest biotech facilities with fermenter volumes of up to 15,000 L.

“The cooperation with Boehringer Ingelheim will increase the value of our services, as both  companies will benefit from the combined expertise and the easy transfer from small/medium to large scale production” commented Dr. Wieland W. Wolf, Vice Chairman of the Rentschler Group.

Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President of the Corporate Division Biopharmaceuticals,  Boehringer Ingelheim GmbH said  “Rentschler Biotechnologie is a strong partner for process development and supply of clinical material in Europe and complements our worldwide strategic Production Alliance Network. Based on compatible process technologies and Boehringer Ingelheims proprietary know-how and expertise in high titer and high yield manufacturing process formats we will combine state-of-the-art development at Rentschler for accelerated time to clinic with a smooth technology transfer to Boehringer Ingelheim for large-scale commercial manufacturing”.


Link to the press release:

http://www.b3c.de/php/popup.php?id=103

About Rentschler Biotechnologie – www.rentschler.de

Rentschler Biotechnologie GmbH is part of the privately held Rentschler Group based in Laupheim, Germany. As an international full-service contract manufacturer with a highly skilled staff of 340, Rentschler Biotechnologie has substantial experience in the development, production and approval of cell culture-derived biopharmaceuticals in compliance with international GMP standards. Regulatory advice and fill & finish are part of the company’s service range. As a pioneer in the development and production of biopharmaceuticals, Rentschler was the first company world-wide to gain market authorization for an interferon-containing drug. In 2006, Rentschler announced an investment program of €50 million for expansion of production systems. Currently the first 2,500-L GMP fermentation line is being commissioned.


About Boehringer Ingelheim – www.boehringer-ingelheim.com/biopharm

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing innovative products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of almost 11 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Boehringer Ingelheim is one of the leading companies for industrial customer manufacturing of Biopharmaceuticals by offering the entire production technology chain in development and production at its biopharmaceutical facilities in Biberach (Germany) and in Vienna (Austria). The large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody fragments and plasmid DNA. The Biberach site is specialized in highly efficient mammalian cell culture systems with yields well above industry standard in animal component free media. The Austria site offers high-expression in bacteria and yeast with exceptionally high productivities using proprietary systems. In the plasmid DNA manufacturing arena Boehringer Ingelheim in Austria has set the standard and supplies early to late-stage clinical trials with gene-therapeutics and DNA vaccines for its international clients. For more information see: http://www.boehringer-ingelheim.com/biopharm

 


Rentschler Biotechnologie gibt  Zusammenarbeit mit Boehringer Ingelheim bekannt

 

Laupheim, 21. Mai 2008 – Rentschler Biotechnologie und Boehringer Ingelheim, beides  führende Unternehmen im Bereich der biopharmazeutischen Entwicklung und Herstellung, haben eine „preferred partnership“-Vereinbarung unterschrieben. Durch die Zusammenarbeit erhalten Kunden von Rentschler Biotechnologie Zugang zu Boehringer Ingelheims großtechnischen Anlagen zur biopharmazeutischen Produktion in Säugetierzellen in Biberach. Im Gegenzug erhalten Boehringer Ingelheims Kunden die Möglichkeit,  Rentschlers Anlagen für Prozess-Entwicklung und Herstellung von klinischen Prüfmustern im mittleren Maßstab zu nutzen.

Die Zusammenarbeit ermöglicht den Kunden aus der Pharma- und Biotech-Industrie die kombinierte Entwicklungs-und Herstellungserfahrung und die Produktionsinfrastruktur beider Unternehmen zu nutzen, Serviceleistungen können durch die gewonnene Flexibilität optimal auf Kundenwünsche abgestimmt werden. Beide Unternehmen liegen in räumlicher Nähe zueinander und verfügen über kompatible Prozess-Technologien, so dass ein nahtloser Übergang bei Projekttransfers gewährleistet ist.

Rentschler Biotechnologie, ein Full-Service-Auftragshersteller für biopharmazeutische Prozess-Entwicklung und Produktion in Säugetierzellen vom kleinen bis mittleren Maßstab, besitzt zurzeit acht unabhängige GMP-Produktionsanlagen mit Fermentervolumina bis zu 500 Litern. Eine weitere 2.500 L Anlage wird derzeit in Betrieb genommen. Boehringer Ingelheim bietet ähnliche Leistungen und Technologien allerdings für die großtechnische Marktproduktion und betreibt eine der weltweit größten Produktionsanlagen mit Fermentervolumina bis zu 15.000 Litern.

„Die Zusammenarbeit mit Boehringer Ingelheim wird den Nutzen unserer Dienstleistungen weiter erhöhen. Beide Unternehmen werden von der gemeinsamen Erfahrung sowie dem leichten Prozess-Transfer von dem kleinen/mittleren Maßstab in den großen Maßstab profitieren“, kommentiert Dr. Wieland W. Wolf, Stellvertretender Geschäftsführer der Rentschler Gruppe.

Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President der Corporate Division  Biopharmaceuticals, Boehringer Ingelheim GmbH:“Rentschler Biotechnologie ist ein starker Partner für Prozessentwicklung und Herstellung von klinischem Prüfmaterial in Europa und ergänzt unser weltweites Netzwerk strategischer Produktionsallianzen. Basierend auf kompatiblen Prozesstechnologien und Boehringer Ingelheims geschütztem Know-How und Erfahrung in Hochtiterverfahren mit hoher Ausbeute kombinieren wir modernste Prozessentwicklung bei Rentschler für zügige Bereitstellung von klinischem Prüfmaterial mit einem nahtlosen Technologietransfer zur kommerziellen Fertigung im Großmaßstab bei Boehringer Ingelheim.“

 

Link zur Pressemitteilung:

http://www.b3c.de/php/popup.php?id=104

Über Rentschler Biotechnologie – www.rentschler.de

Rentschler Biotechnologie GmbH ist ein Unternehmen der Rentschler Gruppe mit Sitz in Laupheim, Deutschland. Als internationales Full-Service-Auftragsunternehmen mit 340 hochqualifizierten Mitarbeitern hat Rentschler Biotechnologie über 30 Jahre Erfahrung mit der Entwicklung, Produktion und Zulassung von Biopharmazeutika, konform mit den internationalen GMP-Standards. Zum Servicespektrum des Unternehmens gehören auch die Zulassungsberatung und Fill & Finish. Rentschler zählt zu den Pionieren bei der Entwicklung und Herstellung von biopharmazeutischen Produkten und war weltweit das erste Unternehmen, das die Zulassung für ein Interferonpräparat erhalten hat. 2006 gab Rentschler ein Investitionsprogramm von 50 Millionen Euro zur Erweiterung der Produktionsanlagen bekannt. Die erste neue 2.500 L GMP Anlage befindet sich zurzeit in der Qualifizierung (IQ/OQ) und wird im Juni 2008 in Betrieb gehen.

Ãœber Boehringer Ingelheim – www.boehringer-ingelheim.com/biopharm

Der Unternehmensverband Boehringer Ingelheim zählt weltweit zu den 20 führenden Pharmaunternehmen. Mit Hauptsitz in Ingelheim am Rhein ist Boehringer Ingelheim weltweit mit 135 verbundenen Unternehmen in 47 Ländern tätig und beschäftigt fast 39.800 Mitarbeiter. Schwerpunkte des 1885 gegründeten Unternehmens in Familienbesitz liegen in der Forschung, Entwicklung, Produktion sowie dem Marketing neuer Arzneimittel mit hohem therapeutischem Nutzen für die Humanmedizin sowie die Tiergesundheit. Im Jahr 2007 erwirtschafte Boehringer Ingelheim Gesamterlöse von 11 Milliarden Euro. Fast ein Fünftel der Einnahmen aus dem größten Bereich – verschreibungspflichtige Medikamente – investierte das Unternehmen in die Forschung und Entwicklung neuer Medikamente.

Boehringer Ingelheim ist eines der führenden Unternehmen in der Auftragsentwicklung und -herstellung von Biopharmazeutika und bietet an seinen Standorten in Biberach/Riss (Deutschland) und Wien (Österreich) die gesamte biopharmazeutische Prozesskette an – von der Entwicklung der Produktionszelle über die Prozessentwicklung bis zur Herstellung des Marktproduktes im wirtschaftlichen Maßstab. In den Produktionsanlagen werden biopharmazeutische Produkte wie therapeutische Proteine, Fusionsproteine, Protein-Scaffolds, monoklonale Antikörper, Antikörperfragmente und Plasmid-DNA-Produkte im Großmaßstab hergestellt. Am Standort Biberach liegt der Schwerpunkt der biopharmazeutischen Herstellung auf der Hochexpression in Säugetierzellkulturen mit Ausbeuten weit über dem Branchenstandard in ACF-Medien (ohne tierische Komponenten), am Standort Wien auf der Hochexpression in Mikroorganismen und Hefekulturen mit außergewöhnlich hoher Produktivität unter Einsatz selbst entwickelter Systeme. Auf dem Gebiet der Herstellung von Plasmid-DNA-Produkten setzt Boehringer Ingelheim in Österreich den weltweiten Maßstab und beliefert sowohl frühe als auch späte klinische Studien für seine internationalen Auftraggeber mit Gentherapeutika und DNA-Impfstoffen.

Weitere Informationen: http://www.boehringer-ingelheim.com/biopharm

Posted under Business and Investment, Clinical Trials, Collaborations, DNA Reasearch, Europe, Press Releases  |  No Comments

Seegene Multi-Pathogen Detection Tests Now Compatible with Lab901 ScreenTape and Caliper LC90 Automated Detection Systems

Last Updated on Wednesday, 30 April 2008 05:36 Written by admin Wednesday, 30 April 2008 05:36

Rockville, MD, April 23, 2008: Seegene today announced that its Seeplex(R) multi-pathogen tests are now optimized for Lab 901′s ScreenTape(R)  and Caliper LifeSciences’ LC90(R)  automated detection systems. Compatibility with these two leading detection systems opens the way for Seeplex tests to be used throughout a wide spectrum of labs, from small to mid-sized labs to large commercial reference labs.

Seeplex tests are based on a breakthrough multiplexing PCR technology capable of detecting multiple pathogens in a single tube. Seeplex-based tests deliver maximum specificity, reproducibility and sensitivity and can be applied to a broad range of molecular diagnostics, including human, animal, plant and microorganism. Currently, Seegene’s Seeplex multi-pathogen detection tests offer labs worldwide simple, cost-effective and comprehensive screening for STDs, respiratory viruses, human papillomaviruses, sepsis and pneumonia.

“Our broad portfolio of multi-pathogen detection tests being optimized for ScreenTape and the Caliper LC90 systems will make it easier for clinical and research labs of all sizes to take advantage of our technology,” said Dr. Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene. “Both the Lab901 and Caliper LifeSciences systems represent the cutting edge of automated detection. Working in combination with these leading systems provides a powerful high-throughput method for analyzing test results.”

The ScreenTape system is the first fully automated, walk-away solution for gel electrophoresis. ScreenTape will automate the simultaneous analysis of eight or sixteen Seeplex PCR samples. Processing speed for 8 samples is completed within 10 minutes;  16 samples within 15 minutes. ScreenTape displays results using easy to interpret color codes. The ScreenTape system comprises the TapeStation (that carries out liquid handling, electrophoresis and imaging), ScreenTape (a consumable that contains the pre-cast, pre-packaged gel and running buffer) and bespoke software. With no gel or buffer preparation and no system priming, even untrained operators can rapidly generate accurate and reproducible test data.

The LabChip 90 System performs fast, automated, 1-D electrophoretic separations of protein, DNA, and RNA samples directly from a 96 or 384 well plate. The LC90 can load and read 96 Seeplex samples within 45 minutes or 384 Seeplex samples in 4 hours in easy-to-interpret reports.

Seegene is currently working to optimize Seeplex tests for other automated capillary electrophoresis systems. Seeplex’s compatibility with a wide range of automated detection systems will provide end-users with the flexibility to use the platform best suited for their purposes.

About Seeplex(R) System: Frontier of Multi-pathogen Detection

Seeplex(R) is a breakthrough multiplexing PCR technology that enables a new standard in simultaneous multi-pathogen detection. Seeplex works in combination with automatic detection systems such as Capillary Electrophoresis and delivers a benchmark in testing accuracy, efficiency and cost-effectiveness.

About Seegene

Seegene, Inc. is pioneering the field of multi-pathogen testing. Seegene applies its novel and proprietary Seeplex system utilizing “DPO (Dual Priming Oligo)” and “ACP (Annealing Control Primer)” to create multi-pathogen tests delivering maximum specificity, reproducibility and sensitivity. With over 260 citations and several patents and patents pending, Seegene has been offering advanced molecular diagnostics services to over 1,000 major global institutes in more than 25 countries. Seegene is actively working with both the scientific and OEM business community. Seegene’s mission is to integrate Seeplex with disease diagnostics to provide a new guideline for effectively treating patients. Seegene was founded in 2000 and is based in Rockville, MD and Seoul, Korea. For more information please visit www.seegene.com.

Posted under DNA Reasearch, Equipment & Supplies, New Products, North America, Press Releases, RNA Reasearch  |  No Comments

DNA with a twist: New company to search for cancer drugs and antibiotics

Last Updated on Wednesday, 13 February 2008 02:12 Written by Fred Wednesday, 13 February 2008 02:12

A new company has joined the fight against MRSA and cancer. Researchers at the John Innes Centre (Norwich) have launched a new company, Inspiralis Ltd, based around their expertise in DNA topoisomerases – a group of enzymes that help DNA molecules to unravel and wind up properly and not to become tangled during replication.

“DNA becomes tangled as a result of various cellular processes, such as replication, which ultimately stops these processes continuing. DNA topoisomerases untangle it. Without them cells die”, says Inspiralis co-founder Dr Nicolas Burton.

Topoisomerases are already targets for several drugs, including anti-tumour drugs and antibiotics, such as ciprofloxacin – the anti-anthrax drug. The search is now on for new ways of inhibiting them. Inspiralis Ltd make a range of products targeted to the pharmaceutical industry to enable drug-discovery work in this area including topoisomerase enzymes themselves as well as associated products.

A new high-throughput assay, developed recently in the laboratory of Prof. Tony Maxwell of the John Innes Centre (and co-founder of Inspiralis), will also provide a huge advance on the standard gel-based screening method for topoisomerase inhibitors. Inspiralis Ltd will develop the technique further as well as offering screening services to companies. “The assay will potentially allow millions of compounds to be screened for activity rather than just hundreds”, says Dr Burton.

The technology can now be accessed as a service or as a kit helping pharmaceutical companies and academics to screen for new and better cancer drugs and antibiotics.

Some powerful antibiotics and key anti-cancer drugs act by inhibiting topoisomerases. In cancer, cells rapidly divide in an uncontrolled manner and topoisomerase inhibitors can block this uncontrolled cell division.

“Topoisomerase inhibitors are key targets for new drug development”, says Mrs Alison Howells (co-founder). “We can test potential new drugs against topoisomerases as well as help discover new inhibitors as a first step to developing brand new drugs”.

Inspiralis is based at the Norwich Bio-Incubator at JIC and was founded with backing from the ICENI fund, a private investor and the John Innes Centre.

The high-throughput assay is patented by JIC’s and BBSRC’s technology transfer company, Plant Biosciences Ltd, and non-exclusive licenses have already been granted to pharmaceutical companies.

Posted under Cancer Research, DNA Reasearch, Europe, Press Releases  |  No Comments

BioServe Announces ControlMATCH for More Efficient Biomarker Validation

Last Updated on Monday, 7 January 2008 01:03 Written by admin Monday, 7 January 2008 01:03

New line of DNA and serum samples for Type II diabetes, hypertension and hyperlipidemia provide researchers access to clinically defined controls to validate biomedical research results

Beltsville, MD, December 4, 2007 – BioServe today introduced ControlMATCH, a new line of fully annotated control DNA and serum samples designed to help biomedical researchers efficiently validate new biomarkers and early stage clinical trial drug candidates. Leveraging BioServe’s Global Repository of 600,000 human biological samples, ControlMATCH allows researchers to select and match control samples to the specific needs of their own DNA and/or serum-based studies.

ControlMATCH DNA and serum controls will initially cover type II diabetes, hypertension and hyperlipidemia, and extend to other disease states in early 2008.

ControlMATCH normal samples for type II diabetes, hypertension and hyperlipidemia are annotated with body mass index (BMI), confirmed normal blood glucose levels, confirmed normal blood pressure and cholesterol levels, and a family history of health status and ethnicity determined by data collected on three generations. ControlMATCH therefore permits researchers to identify one-to-one matched controls for extended criteria such as age, gender, ethnicity, BMI, diet and a host of lifestyle factors. Furthermore, ControlMATCH includes clinically confirmed negative results enabling researchers to further confirm that their markers are valued against the correct set of controls.

Xin Li Wang, a professor and director in the cardiothoracic research laboratory in the division of cardiothoracic surgery of the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, commented, “We are engaged in landmark cardiothoracic studies that we hope will reveal the DNA aberrations in a few target genes responsible for thoracic aortic disease. Like any large epidemiological study, time is money and generating valid results as quickly as possible is a prerequisite for success.”

“The faster a study is able to generate validated results, the higher the probability of achieving longer term program milestones. By providing us with ready made DNA samples stratified by age, ethnicity and smoking status, BioServe’s ControlMATCH has proven to be an indispensable tool in accelerating our research,” he added.

“ControlMATCH was developed to be a powerful validation tool for epidemiologists and researchers investigating a variety of major diseases,” said Kevin Krenitsky, Chief Executive Officer, BioServe.  “DNA and serum control sets linked to extensive clinical, demographic and lifestyle data will enable researchers to both rapidly validate which markers are valuable and worth pursuing, and generally contribute to the genetic understanding of debilitating disease.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository®, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

Posted under DNA Reasearch, New Products, North America, Press Releases  |  No Comments

Biological Drugs Spurring an Evolution in Injectable Drug Delivery

Last Updated on Thursday, 3 January 2008 07:48 Written by admin Thursday, 3 January 2008 07:48

(Amherst, NH) – The success of recombinant protein drugs such as Enbrel, Remicade, and Herceptin in treating refractory conditions is fueling the search for protein and peptide-based therapeutic agents in oncology, inflammation and a host of other disease classes. Led by the proliferation of antibody-based drug candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and – ultimately – pharmaceutical marketers.

Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones and other biological drugs also increase the need for safety and compliance.

Compliance with drug therapy and disease management protocols has been and is a primary concern within the healthcare and pharmaceutical industries. Efforts to enhance compliance are having a non-negligible effect on drug formulations and delivery decisions, and can be a significant factor in the prescribing decisions of most physicians. Compliance concerns have driven and continue to drive investment in new drug delivery technologies.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.

New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Reusable injectors designed to accept prefilled syringes or drug cartridges will improve ease-of-use and increase alternative device share of the growing self-injection market. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

These findings are contained in a comprehensive report, Injectable Drug Delivery: Evolving Markets, Emerging Opportunities. More information is available at www.greystoneassociates.org .

About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

Posted under Clinical Trials, DNA Reasearch, Discoveries, Innovations and Patents, Equipment & Supplies, North America, Peptide Research, Press Releases, Proteomics, Reports  |  No Comments

BIOSERVE and DNAPRINT(R) GENOMICS FORM STRATEGIC ALLIANCE TO PROVIDE CLINICAL PATIENT SAMPLES TAGGED WITH GENETIC ANCESTRY DATA

Last Updated on Sunday, 14 October 2007 08:34 Written by admin Sunday, 14 October 2007 08:34

BioServe’s fully annotated clinical samples across many diseases to be tagged with ancestry information using DNAPrint’s genetic ancestry tests

BELTSVILLE, MD., Oct. 9, 2007 – BioServe today announced the formation of strategic alliance with DNAPrint® Genomics, Inc. (OTCBB: DNAG) to provide biomedical researchers with clinical DNA samples that for the first time will include genetic ancestry data for each sample. With the added dimension of ancestry information to clinical samples, medical researchers will be able to determine whether certain biological markers are artifacts of genetic ancestry or are true markers for a disease or drug response in a disease. To create the genetic ancestry data, DNAPrint® Genomics will analyze and categorize BioServe’s Global Repository® of nearly 600,000 human biological samples using its ANCESTRYbyDNA(TM) validated genetic ancestry test.

“Our relationship with BioServe is highly synergistic. Both companies believe that any epidemiological program will be more productive with access to high quality validated clinical samples that have been effectively categorized across a validated genetic ancestry platform,” said Richard Gabriel, CEO and President of DNAPrint® Genomics. “By removing the question of ancestry from a clinical sample researchers can more readily evaluate which medicines will produce side effects within certain ethnic groups, and which medicines will work for the widest spectrum of a population.”

“Through this partnership with DNAPrint Genomics we can provide the medical research community with the best defined clinical sample set in the world,” said Dr. Kevin Krenitsky, CEO of BioServe. “Additionally, we are able to uniquely support the application of our samples with services that include sample extraction and preparation, genotyping, and gene expression. Now that we are able to add the genetic ancestry component to our samples, a new layer of sample data quality and analysis can be provided that was not previously available to researchers.”

Both companies are also capable of providing genotyping services, and between the two companies the following platforms are available: Beckman Ultra High Throughput SNP Platform, Illumina SNP Golden Gate, and Sequenom iPLEX. In addition, several gene RNA expression analysis platforms are available including Differential Expression Pattern Display Technology which has an RNA expression sensitivity 10 to 100 times greater than either of Affymetrix or Illumina gene expression profile technologies.

DNAPrintâ„¢ Genomics, Inc.

DNAPrintâ„¢ Genomics, Inc. (www.dnaprint.com) is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company’s proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company’s first theranostic product is PT-401, a “Super EPO” (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (with end stage renal disease). Preclinical and clinical development of all the Company’s drug candidates will benefit from simulated pre-trials to design actual trials better and are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM). DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.

About BioServe

BioServe (www.bioserve.com) is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository®, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com, e-mail info@bioserve.com or call 301-470-3362.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint’s products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.

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