MorphoSys AG announced today the signing of a non-exclusive license and technology transfer agreement between its subsidiary Sloning BioTechnology GmbH and Pfizer. The agreement covers the installation, training and use of Sloning's technology platform Slonomics® for fabrication of highly-diverse gene and protein libraries at Pfizer's subsidiary Rinat Neuroscience Corp. in South San Francisco. The MorphoSys subsidiary will receive an upfront payment in 2010, and stands to receive annual license fees over the patent lifetime of the Slonomics technology platform. Further financial details of the agreement were not disclosed.
Friday 10 December 2010
Three partners bring HuCAL antibodies into clinical trials
MorphoSys AG announced today that three of its partners have filed applications for phase 1 clinical trials with HuCAL antibodies. In each case, the filing of the application triggers an undisclosed milestone payment to MorphoSys. The therapeutic antibodies are being developed in the therapeutic areas of cancer and inflammatory diseases. Today's announcement brings to six the number of HuCAL antibodies that have entered clinical development in 2010. Details on the individual programs will be published as the respective trials commence.
Surgery complications linked to chemotherapy delay, study finds
Patients who have complications after colorectal cancer surgery are less likely to get chemotherapy, even when it is clearly recommended for their diagnosis, a new study from the University of Michigan Comprehensive Cancer Center finds.
In addition, patients with complications were more than twice as likely to have their chemotherapy delayed for more than 120 days after diagnosis or two months after surgery, which is considered the appropriate timeframe for receiving chemotherapy.
“Surgical complications are typically thought to be short-term problems, but our study suggests there is a clear link between downstream cancer care and complications that occur during surgery. This is critical because chemotherapy in this subset of colorectal cancer patients has clear lifesaving benefit,” says lead study author Samantha Hendren, MD. MPH, assistant professor of surgery at the U-M Medical School.
In addition, patients with complications were more than twice as likely to have their chemotherapy delayed for more than 120 days after diagnosis or two months after surgery, which is considered the appropriate timeframe for receiving chemotherapy.
“Surgical complications are typically thought to be short-term problems, but our study suggests there is a clear link between downstream cancer care and complications that occur during surgery. This is critical because chemotherapy in this subset of colorectal cancer patients has clear lifesaving benefit,” says lead study author Samantha Hendren, MD. MPH, assistant professor of surgery at the U-M Medical School.
Drug combination shows promise for newly diagnosed blood cancer, study finds
A new combination of three drugs used to treat the blood cancer multiple myeloma may be effective as a front-line therapy for newly diagnosed patients, according to a study led by the University of Michigan Comprehensive Cancer Center.
The drug combination includes a novel proteasome inhibitor called carfilzomib, combined with lenalidomide and low-dose dexamethasone. This is the first study to look at carfilzomib as a front-line treatment of patients with myeloma, a type of cancer that arises in the plasma cells.
The drug combination includes a novel proteasome inhibitor called carfilzomib, combined with lenalidomide and low-dose dexamethasone. This is the first study to look at carfilzomib as a front-line treatment of patients with myeloma, a type of cancer that arises in the plasma cells.
Integrated flexible process control system supports ‘agile’ pharma manufacturing need
A clear focus upon operational efficiency needs to be at the forefront of any business priority - particularly in the current tough economic environment. Siemens Industry Automation has worked with Wirral-based chemical and pharmaceutical intermediates manufacturer, Phoenix Chemicals to provide process control solutions that have helped deliver three key benefits - enhanced production flexibility, improved product consistency and a reduction in costs.
Thursday 9 December 2010
Ambry Genetics launches Illumina HiSeq 2000 next generation sequencing services
Ambry Genetics, a global leader in genomic services to the healthcare and life sciences industries, announced today that it has officially launched their Illumina HiSeq 2000 Next Generation Sequencing Services. Ambry Genetics has been an early adapter of Illumina sequencing systems since 2007 and has extensive experience as a Certified Service Provider.
“We’ve continued to invest and develop our sequencing operations to become Illumina experts” said Ardy Arianpour, Vice President of Business Development at Ambry Genetics. "All of our customers are excited about the Illumina HiSeq because it expands our whole genome and exome sequencing services to the next level and gives them the opportunity to reduce their costs while providing more data. If Illumina is your preferred platform then we want to be your preferred sequencing provider."
Ambry Genetics has been at the forefront of applying new sequencing technologies that best meet our clients' needs. A team of scientists routinely process libraries for all available applications ranging from small RNAs to whole genome DNA sequencing. Having sequenced thousands of samples involving a wide range of species including human, mouse, bacteria, viruses, and plants, Ambry is known for its reputation for delivering quality data and service as well as the flexibility in customizing projects to meet the specific needs of researchers. Ambry Genetics will get your projects done right.
Ambry Genetics
“We’ve continued to invest and develop our sequencing operations to become Illumina experts” said Ardy Arianpour, Vice President of Business Development at Ambry Genetics. "All of our customers are excited about the Illumina HiSeq because it expands our whole genome and exome sequencing services to the next level and gives them the opportunity to reduce their costs while providing more data. If Illumina is your preferred platform then we want to be your preferred sequencing provider."
Ambry Genetics has been at the forefront of applying new sequencing technologies that best meet our clients' needs. A team of scientists routinely process libraries for all available applications ranging from small RNAs to whole genome DNA sequencing. Having sequenced thousands of samples involving a wide range of species including human, mouse, bacteria, viruses, and plants, Ambry is known for its reputation for delivering quality data and service as well as the flexibility in customizing projects to meet the specific needs of researchers. Ambry Genetics will get your projects done right.
Ambry Genetics
Optimising, adjusting and controlling evaporation methods
Accessible as a pdf download (www.genevac.org/newsletter.htm) the main feature of the new issue focuses upon how to optimise, adjust and control methods on modern centrifugal evaporators. Also in this edition the phenomenon known as "cryopumping" (where a condenser removes vapour from the evaporator chamber to maintain the vacuum level, thereby enabling more vapour to be removed) is discussed.
Focusing purely on technical and applications issues of interest to users of evaporation, concentration and lyophilisation equipment the Genevac eNewsletter is circulated via e-mail 5 times per year.
Endogenous gene-tagging technology used to create first wave of X-MANTAG models
Horizon Discovery today announced it has secured worldwide exclusive rights to a panel of new human isogenic cell models developed by Dr Zhenghe Wang, Assistant Professor of Genetics at Case Western Reserve University School of Medicine, using its proprietary rAAV GENESIS gene-editing platform.
The in-licensed lines will be added to Horizon’s rapidly expanding library (300+) of X-MANTM (gene X- Mutant And Normal) cell models, which are the world’s first source of genetically-defined and patient-relevant human cell lines. These cell lines, which have been referred to as “patients-in-a-test-tube”, accurately model disease-causing mutations. This enables drug discovery researchers to understand how cancer manifests itself in real patients and identify the effect of individual mutations on drug activity, patient responsiveness and resistance. X-MAN cell lines are also being used to successfully predict which patient sub-groups will respond to currently-available and future drug treatments, helping to rationalize many aspects of drug development; and therefore the final cost of new personalized cancer therapies.
The in-licensed lines will be added to Horizon’s rapidly expanding library (300+) of X-MANTM (gene X- Mutant And Normal) cell models, which are the world’s first source of genetically-defined and patient-relevant human cell lines. These cell lines, which have been referred to as “patients-in-a-test-tube”, accurately model disease-causing mutations. This enables drug discovery researchers to understand how cancer manifests itself in real patients and identify the effect of individual mutations on drug activity, patient responsiveness and resistance. X-MAN cell lines are also being used to successfully predict which patient sub-groups will respond to currently-available and future drug treatments, helping to rationalize many aspects of drug development; and therefore the final cost of new personalized cancer therapies.
Simulation technology for diseases of the nervous system
Rhenovia Pharma SAS, a biotechnology company specialized in the development and optimization of treatments for diseases of the central and peripheral nervous system, announces today that it has signed a strategic partnership agreement with the French Muscular Dystrophy Association (Association Française contre les Myopathies – AFM). The two-year agreement is worth more than 500,000 Euros.
This strategic collaboration is aimed at speeding up the development of Rhenovia’s unique technology for simulating neuronal transmission and pushing ahead with experimental validation so as to be able to apply the technology faster. It will give AFM access to a speedier scientific approach for discovering and developing new pharmacological treatments for rare neurodegenerative diseases. This approach will also benefit pathologies that affect larger patient numbers, such as Alzheimer’s and Parkinson’s.
This strategic collaboration is aimed at speeding up the development of Rhenovia’s unique technology for simulating neuronal transmission and pushing ahead with experimental validation so as to be able to apply the technology faster. It will give AFM access to a speedier scientific approach for discovering and developing new pharmacological treatments for rare neurodegenerative diseases. This approach will also benefit pathologies that affect larger patient numbers, such as Alzheimer’s and Parkinson’s.
Scientists to explore African waters for potential new drug discoveries
Scientists are to explore seas off the coast of West Africa, in research that could lead to the discovery of new treatments for diseases including cancer and MRSA.
Experts from the University of Aberdeen’s Marine Biodiscovery Centre and the Division of Applied Medicine will travel to Ghana next month to search waters for unique marine organisms which could be used to develop new medicines.
This is the first time a systematic exploration of marine organisms off the West African coast has taken place, and scientists anticipate their expedition will reveal previously undiscovered species of corals, sponges and sea squirts.
Once collected they will examine these organisms for new molecules, bacteria and fungi which could be used in drug development.
Experts from the University of Aberdeen’s Marine Biodiscovery Centre and the Division of Applied Medicine will travel to Ghana next month to search waters for unique marine organisms which could be used to develop new medicines.
This is the first time a systematic exploration of marine organisms off the West African coast has taken place, and scientists anticipate their expedition will reveal previously undiscovered species of corals, sponges and sea squirts.
Once collected they will examine these organisms for new molecules, bacteria and fungi which could be used in drug development.
Precision and high-throughput to AssayMAP micro-scale chromatography
BioSystem Development and Agilent Technologies Inc have announced a collaborative agreement to implement BioSystem Development’s patented technology on the established Agilent Bravo automated liquid handling platform.
BioSystem Development is a privately held life sciences analytics company and creator of AssayMAP high-throughput micro-chromatography technology. The combined technologies will produce for the first time true chromatography separations on disposable, 5ul packed-bed columns in a 96-channel SBS microplate format.
The collaboration creates a versatile integrated solution for protein sample preparation and processing. The new open-platform instrument combines the Agilent Bravo with 96AM head with AssayMAP cartridges that are packed with any chromatographic resin or immobilized enzyme. The new instrument enables a broad range of standard analytical workflows to be rapidly reformatted to this precision, high-throughput platform.
BioSystem Development is a privately held life sciences analytics company and creator of AssayMAP high-throughput micro-chromatography technology. The combined technologies will produce for the first time true chromatography separations on disposable, 5ul packed-bed columns in a 96-channel SBS microplate format.
The collaboration creates a versatile integrated solution for protein sample preparation and processing. The new open-platform instrument combines the Agilent Bravo with 96AM head with AssayMAP cartridges that are packed with any chromatographic resin or immobilized enzyme. The new instrument enables a broad range of standard analytical workflows to be rapidly reformatted to this precision, high-throughput platform.
Sintered porous plastic encourages in-vitro cell culture growth
The efficient transfer of oxygen is essential for cell culture. The uniform porosity and pore size of BioVyon materials produces the consistent and uniform bubble sizes and patterns required to achieve superb oxygen transfer. Products can be made in tubes or flat sheet for OEM customers. BioVyon materials are manufactured under cGMP conditions enabling achievement of the highest cleanliness standards demanded by these applications and have USP Class 6 regulatory approval.
Results are presented (www.porvairfiltration.com/view/BiosciencesAndScientific/CellCulture.aspx) for applications using BioVyon scaffolds to accelerate oesteoblast (bone cell) proliferation and provide efficient and accurate differentiation of adult and embryonic stem cells.
Manufactured in an ISO accredited clean room environment - BioVyon™ sintered porous plastics offer the high degree of biocompatibility and bio-safety required by many life science and healthcare applications.
Porvair Filtration Group
Wednesday 8 December 2010
Klaus Besier is appointed to ERT's board of directors
Mr Besier brings to ERT more than 30 years of executive experience in leading software technology companies. He has served as President and CEO of SAP America, Inc. and is credited with driving its growth in North and South America, Australia and New Zealand from $50 million to $1 billion in revenues in less than five years. In addition, as President and CEO of Firepond Inc, Mr Besier took the company public in one of the most successful IPOs of 2000.
Guideline for quantitative molecular methods for infectious diseases
The Clinical and Laboratory Standards Institute (CLSI) recently published a revised document, Quantitative Molecular Methods for Infectious Diseases; Approved Guideline-Second Edition (MM06-A2). The document recognizes the increased use of quantitative molecular methods for determining the concentration of microorganisms in patients.
CLSI document MM06 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretation of results.
CLSI document MM06 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretation of results.
Mirrorball offers equivalent data with minimal changes to assay protocols
Mix-and-read assays, first popularized as FMAT assays, were developed to overcome the problems associated with automating ELISAs particularly in cell-based methods. This new comparative study has used the FMAT assay to look at bead-based quantitation of a soluble protein (rabbit IgG) and antibody binding to EGF receptors expressed in A459 cells. The Mirrorball system scanned the entire well, and FMAT reported data from only a 1 mm2 area in each well. Beads were identified by laser scatter on Mirrorball and fluorescence on FMAT. The Mirrorball system could enumerate beads in all wells, in contrast to FMAT which could not detect all beads below 1 ng/mL rabbit IgG.
The study demonstrated that the performance of both systems was broadly similar. For the full application note detailing this comparative study please visit www.ttplabtech.com/emailers/mirrorball-benchmarking-study.html
TTP LabTech Ltd
MIQE compliant overview of qPCR research technique
Providing user guidance on the entire qPCR process - from RNA isolation to data analysis - the manual covers the basics of experimental set-up, performance and analysis. Specific information on 5’ nuclease assays, including re-suspensions and qPCR protocols are also supplied, as well as a troubleshooting section which discusses commonly encountered issues.
The entire document is written in compliance with MIQE guidelines: minimum information for publication of quantitative real-time PCR1.
IDT offers a broad range of PrimeTime qPCR assay products including customized primers and probes, in addition to the free online design suite - SciTools.
1. Bustin, S.A. et al. The MIQE guidelines: minimum information for publication of quantitative real-time PCR experiments. Clin Chem, 2009. 55(4): p. 611-22.
Qlucore Omics Explorer 2. allows scientists to work with datasets containing up to 150 samples and 2 million variables
Qlucore, a leader in the development of bioinformatics software, has today unveiled Qlucore Omics Explorer 2.2, the latest version of its advanced data analysis software, which now features new built-in functionality to import and normalise miRNA data, mRNA data and DNA methylated data.
Qlucore Omics Explorer 2.2 (OE 2.2) also now allows for the direct import of data generated with Agilent equipment. Data generated with the Agilent Feature Extraction software can now be directly imported into Qlucore Omics Explorer 2.2, so that scientists, biologists and other researchers benefit from a more streamlined workflow. The import functionality included with Qlucore Omics Explorer 2.2 also features inbuilt pre-settings for well-defined data types, as well as a flexible interface for the normalisation of other data types.
Qlucore Omics Explorer 2.2 (OE 2.2) also now allows for the direct import of data generated with Agilent equipment. Data generated with the Agilent Feature Extraction software can now be directly imported into Qlucore Omics Explorer 2.2, so that scientists, biologists and other researchers benefit from a more streamlined workflow. The import functionality included with Qlucore Omics Explorer 2.2 also features inbuilt pre-settings for well-defined data types, as well as a flexible interface for the normalisation of other data types.
Liver microsomes enables advanced drug development research
Sera Laboratories International Ltd, the serum specialist, has launched a comprehensive range of liver microsome products from over 12 species, including mouse, rabbit, monkey and chicken. Researchers can select from pure microsomes or S9 fractions, and animal liver cytosol is also available. In order to facilitate requirements recommended by REACH, Sera Lab is also able to supply bespoke microsome products from other species or strains, as required. Each product is accompanied by a Certificate of Analysis.
Microsomes are a valuable tool for investigating drugs metabolism (enzyme inhibition, clearance and metabolite identification), as well as for examining in vitro drug-drug interactions. They are produced by mechanically homogenising cells such that the endoplasmic reticulum is fragmented, the fractions of which reform into microsomes, which are subsequently collected from the cell remnants via differential centrifugation. During this process, the numerous different phase I cytochrome P450 enzymes (CYPs) are concentrated within the microsomes. The S9 fraction contains microscomes as well as cytosolic phase II metabolism-related enzymes.
With this extensive portfolio of microsomes and S9 fractions, as well as the capability to provide bespoke products, Sera Lab offers researchers the opportunity to match the species, strain and enzyme activity requirements for successful drug metabolism studies.
Sera Lab
Microsomes are a valuable tool for investigating drugs metabolism (enzyme inhibition, clearance and metabolite identification), as well as for examining in vitro drug-drug interactions. They are produced by mechanically homogenising cells such that the endoplasmic reticulum is fragmented, the fractions of which reform into microsomes, which are subsequently collected from the cell remnants via differential centrifugation. During this process, the numerous different phase I cytochrome P450 enzymes (CYPs) are concentrated within the microsomes. The S9 fraction contains microscomes as well as cytosolic phase II metabolism-related enzymes.
With this extensive portfolio of microsomes and S9 fractions, as well as the capability to provide bespoke products, Sera Lab offers researchers the opportunity to match the species, strain and enzyme activity requirements for successful drug metabolism studies.
Sera Lab
Topographic confocal Raman imaging
Large-area topographic coordinates from the profilometer measurement can be precisely correlated with the large-area confocal Raman imaging data. This allows for the first time confocal Raman imaging along heavily inclined or very rough samples with the true surface held in constant focus while maintaining the highest confocality.
With the new imaging mode, samples that had previously required extensive preparation in order to obtain a certain surface flatness can now be effortlessly and automatically characterized as they are. Complete system control as well as extensive data evaluation are integrated within the WITec Control and WITec Project software environment, guaranteeing renowned ease-of-use.
“The integrated combination of optical profilometry and large-area confocal Raman imaging is the next evolutionary leap in cutting-edge microscope configurations.” says Dr. Olaf Hollricher, WITec managing director R&D. “Only an inherently modular instrument design can enable such a seamless incorporation of a groundbreaking and complementary imaging technique into the present product line of Raman-AFM systems.”
The profilometry capabilities of True Surface Imaging mode allows scan ranges of up to 100x100 mm with a spatial resolution on the order of 100 nm vertically and 10 µm laterally. Measuring distances of 10 mm and more provide flexibility for variable sample size requirements. In combination with AFM, the profilometer can even be used as a pre-inspection tool to determine topographic features of interest for high-resolution AFM investigations on large samples. The overall performance and exceptionally accurate imaging capabilities of True Surface Microscopy are beneficial for many applications, including the characterization of micromechanical, medical, or semiconductor devices, the mapping of functionalized surfaces, or the imaging of bio-medical or pharmaceutical material surface properties.
The image shows an application example illustrating the working principle of True Surface Microscopy (Topographic Raman Image of a Pharmaceutical Tablet).
WITec
Phase II genital herpes trial with AIC316 completed
AiCuris announced today that the last subject has completed their Phase-II trial "A double-blind randomized placebo controlled dose-finding trial to investigate different doses of a new antiviral drug in subjects with genital HSV Type 2 infection".
The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol.
“We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus” said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. “In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes”.
AiCuris plans to have the first data available in early 2011. “We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action”, adds Prof. Rübsamen-Schaeff, CEO of AiCuris.
Herpes simplex viruses (HSV) are widespread in the human population (seroprevalence up to 100%, depending on geographic area and subpopulation), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly transmitted sexually. However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries. Both labial and genital herpes are generally self-limiting but can recur frequently. HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV. In immune compromised individuals large and painful ulcerations may result, and newborns infected with HSV are at risk of developing herpes encephalitis. Unlike most of the current herpes drugs, which inhibit a specific viral enzyme, the DNA polymerase, AIC316 acts by a unique mechanism of viral inhibition. Currently available therapies share the same mode of action and are therefore similar in their efficacy, whilst in addition exhibiting possible cross-resistance.
AiCuris
The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol.
“We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus” said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. “In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes”.
AiCuris plans to have the first data available in early 2011. “We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action”, adds Prof. Rübsamen-Schaeff, CEO of AiCuris.
Herpes simplex viruses (HSV) are widespread in the human population (seroprevalence up to 100%, depending on geographic area and subpopulation), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly transmitted sexually. However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries. Both labial and genital herpes are generally self-limiting but can recur frequently. HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV. In immune compromised individuals large and painful ulcerations may result, and newborns infected with HSV are at risk of developing herpes encephalitis. Unlike most of the current herpes drugs, which inhibit a specific viral enzyme, the DNA polymerase, AIC316 acts by a unique mechanism of viral inhibition. Currently available therapies share the same mode of action and are therefore similar in their efficacy, whilst in addition exhibiting possible cross-resistance.
AiCuris
See off Alzheimer’s with the colour purple
Eating purple fruits such as blueberries and drinking green tea can help ward off diseases including Alzheimer’s, Multiple Sclerosis and Parkinson’s, a University of Manchester report claims.
Ground-breaking research from Professor Douglas Kell, published in the journal Archives of Toxicology, has found that the majority of debilitating illnesses are in part caused by poorly-bound iron which causes the production of dangerous toxins that can react with the components of living systems.
These toxins, called hydroxyl radicals, cause degenerative diseases of many kinds in different parts of the body.
Ground-breaking research from Professor Douglas Kell, published in the journal Archives of Toxicology, has found that the majority of debilitating illnesses are in part caused by poorly-bound iron which causes the production of dangerous toxins that can react with the components of living systems.
These toxins, called hydroxyl radicals, cause degenerative diseases of many kinds in different parts of the body.
Tuesday 7 December 2010
Phase I study: recombinant human interleukin-7 (CYT107) promotes T-cell recovery following T-cell depleted allogeneic hematopoietic stem cell transplantation
Early clinical results from study conducted at Memorial Sloan-Kettering Cancer Center suggest that CYT107 enhances immune recovery without causing graft-versus-host disease in immunodeficient transplant recipients who are vulnerable to a variety of bacterial, viral, and fungal infections
Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants. Preliminary assessment of the immunological effects of CYT107 in eight evaluable patients demonstrates a median increase in CD4 T-cells exhibiting a naïve or central memory phenotype of 69 per cent over baseline, and a median increase in CD8 T-cells exhibiting a naïve or effector memory phenotype of 94 per cent over baseline.
The study is being conducted at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, where Marcel R.M. van den Brink, MD, PhD, Head, Division of Hematologic Oncology, and Miguel-Angel Perales, MD, Director, Adult Bone Marrow Transplantation Fellowship Program, serve as Principal Investigator and co-Principal Investigator, respectively.
Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants. Preliminary assessment of the immunological effects of CYT107 in eight evaluable patients demonstrates a median increase in CD4 T-cells exhibiting a naïve or central memory phenotype of 69 per cent over baseline, and a median increase in CD8 T-cells exhibiting a naïve or effector memory phenotype of 94 per cent over baseline.
The study is being conducted at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, where Marcel R.M. van den Brink, MD, PhD, Head, Division of Hematologic Oncology, and Miguel-Angel Perales, MD, Director, Adult Bone Marrow Transplantation Fellowship Program, serve as Principal Investigator and co-Principal Investigator, respectively.
Enhancing calibration laboratory capability
This additional instrumentation also helps to ensure the guaranteed five working day or less turnaround calibration service, which was implemented over ten years ago along with the Starna Lifetime Guarantee as part of the Starna customer assurance protocol, under the ISO17025 accreditation program.
“Having three fully qualified reference spectrophotometers, controlled in an ISO 17025 & ISO Guide 34 accredited environment, ensures that Starna always has the confidence of cross validated measurements, produced by having comparative back-up systems available at all times,” explained John Hammond, Starna’s Technical and Marketing Manager. “This is a clear benefit for our customers because we believe this measurement capability can only be matched in National Measurement Institute (NMI) laboratories and it adds another ‘layer of confidence’ to our already comprehensive qualification and control programme”.
Utilising the extensive UV/Visible/NIR wavelength range capabilities of the Cary 5000, allows for the Starna extended range of Certified Reference Materials (CRMs) providing one of the most comprehensive ranges of UV/Visible/NIR materials found in the scope of any ISO Guide 34 + ISO/IEC 17025 accredited Reference Material producer.
These CRMs are essential for ISO/IEC accredited laboratories, pharmaceutical QA/QC or metrology departments, and enable them to provide Operational Qualification (OQ) and Performance Qualification (PQ) of their own UV/Visible/NIR instrumentation using ‘Industry Standard’ protocols.
Starna is an accredited Reference Material producer to ISO Guide 34 and ISO/IEC 17025 meeting all ILAC MRA requirements.
Starna Scientific
British Pharmacopoeia available to view on iPhone and iPad
The 2011 edition of the six-volume BP has been optimised for easy viewing on the Apple iPad for the first time, meaning all 5,468 pages are now at your fingertips and easily portable.
First published in 1864 and legally effective in the UK from 1 January, the 2011 edition contains 51 new monographs for formulated preparations and additional standards for widely used unlicensed formulations.
Arab Health 2011: INTEGRA displays liquid handling products
Visitors to Sheikh Maktoum Hall, at the Dubai International Exhibition Centre, UAE (24-27th January 2011), will have the chance to see and discuss INTEGRA's complete range of handheld pipetting systems offering accurate liquid handling from 0.5µl to 100ml.
Proven in nearly two hundred thousand installations worldwide the PIPETBOY pipettor range sets a high benchmark for ease-of-use, reliability, build quality, performance and operational safety. Each PIPETBOY pipettor can be used with plastic or glass pipettes with volumes of 1-100 ml. Offering accurate high productivity parallel pipetting from 0.5µl to 1250µl - Voyager multi-channel pipettors are the perfect liquid handling tool for applications including sample reformatting, PCR Reaction set-up, ELISA sample transfers and Taqman Assay set-up. Using a proprietary motorised adjustable spacing mechanism - Voyager pipettors eliminate cross contamination and ensure consistent, accurate and extraordinary fast delivery of liquids.
At this important event INTEGRA will also be displaying its industry leading MEDIAJET Automated Petri Dish Filling systems. High quality media for the cultivation of bacteria is at the core of numerous medical and microbiological laboratory applications. As a consequence, many downstream tasks and results directly depend on ensuring a reliable and efficient process for preparing high quality media.
Perfectly complimenting the MEDIACLAVE - which enables laboratories to prepare high quality culture media - the excellent reliability and true walk-away automation provided by the MEDIAJET significantly reduces operational downtime and labour costs associated with traditional Petri dish filling systems. The extensive capabilities of the MEDIAJET includes high throughput filling of Petri dishes of various sizes, Petri dishes with two compartments, test tubes and an integrated shaker function that provides a convenient solution for pour plate applications.
INTEGRA is an ISO 9001 certified company.
INTEGRA Biosciences
Porvair Sciences announces international sales growth
Reflecting upon the positive year - Steve Knight (Sales & Marketing Director) commented: "The growth in 2010 reflects our continuing investment in new innovative products, striving to maintain top product quality and a commitment to informed product support". He added "In 2010 we saw particular growth in demand for our growing range of high quality, high performance deep well and assay plates".
Looking into 2011 the company is planning to introduce further new products and product upgrades to facilitate its targeted market growth in Asia, Europe and North America.
Porvair Sciences Ltd has specialised in the manufacture of microplates and microplate equipment since its formation in 1992. Via its global distributor network, Porvair Sciences serves Life Sciences, Biotechnology, R&D and Molecular Biology with microplate solutions for all applications, from sample preparation to high throughput screening. Porvair Sciences is a subsidiary of Porvair plc, a world leader in microporous materials.
Porvair Sciences Ltd
Methods for evaluating lyophilized product
The physical appearance of a lyophilized product can provide significant insight into the attributes of a product and relative effects of processing. Developing a detailed cake description during the development of a lyophilized product is important in order to discern subtle differences with regards to formulation variations, product designs, processing variables, and the impact of scale-up activities on product appearance. Cake descriptions also present an opportunity to compare physical characteristics, which can provide determination of vial to vial and batch to batch uniformity during the product development process.
Chaired by Wendy Sunderland (Lyophilization Technology) - the scope of the 15th December 2010 webinar will be to discuss how development of a standard method for evaluating lyophilized product in a laboratory setting requires uniformity in cake descriptions. Examples will be presented of how a thorough cake description including colour, macroscopic and microscopic structure, and texture of the lyophilized product is required by organisations looking to develop a reliable manufacturing inspection standard.
SP Scientific's program of free educational webinars delivered by industry experts are devoted to freeze-drying topics, and follow a 30-minute format for the presentations with a Q&A session immediately afterwards.
To register for the December 15, 2010 webinar please visit the SP Scientific website.
Liquid scintillation counter is accurate for 80:1 samples
When a new metabolic research laboratory looked for an automatic liquid scintillation counter for Tritium:C14 dual labelling, it found one that achieved outstanding resolution on samples that other instruments were unable to count accurately – and at a much lower whole-life cost.
The MRC Centre for Obesity and Related Metabolic Diseases (MRC CORD) at the University of Cambridge purchased the 300SL counter from LabLogic Systems following a demonstration at which it successfully counted 80:1 samples of both C14:Tritium and Tritium:C14.
In the longer term the 300SL will also save MRC CORD money because it uses the ‘Triple to Double Coincidence Ratio’ absolute activity measurement method (the first instrument of its kind to do so), doing away with the need for a gamma source to compensate for the quench phenomenon for pure beta emitters.
That means there are no costs associated with setting up a source in the first instance, maintaining authorisation records and addressing safety issues during the counter's useful life and ultimately disposing of the source safely.
LabLogic was also able to meet all MRC CORD’s radiation safety needs from its extensive product range. Included were a Triathler portable radiation counter for wipe tests and - as a temporary back-up to the 300SL - Rad-Mon radiation monitors and shielding products.
LabLogic Systems Limited
The MRC Centre for Obesity and Related Metabolic Diseases (MRC CORD) at the University of Cambridge purchased the 300SL counter from LabLogic Systems following a demonstration at which it successfully counted 80:1 samples of both C14:Tritium and Tritium:C14.
In the longer term the 300SL will also save MRC CORD money because it uses the ‘Triple to Double Coincidence Ratio’ absolute activity measurement method (the first instrument of its kind to do so), doing away with the need for a gamma source to compensate for the quench phenomenon for pure beta emitters.
That means there are no costs associated with setting up a source in the first instance, maintaining authorisation records and addressing safety issues during the counter's useful life and ultimately disposing of the source safely.
LabLogic was also able to meet all MRC CORD’s radiation safety needs from its extensive product range. Included were a Triathler portable radiation counter for wipe tests and - as a temporary back-up to the 300SL - Rad-Mon radiation monitors and shielding products.
LabLogic Systems Limited
Monday 6 December 2010
Biocitech announces the arrival of OCT Santé on its campus
Biocitech, the Parisian life sciences technology park, today announced the installation of a new firm, OCT Santé, on its campus. OCT Santé is the 25th company to relocate to Biocitech, where the occupation rate is now over 90 per cent.
The installation of this new tenant not only confirms the park’s success but also enables Biocitech to expand the range of services it offers to the biopharmaceutical industry downstream from its medical research-and-development activities. These services now include the transport of biologicals in optimum conditions and the development of packaging methods that comply with current standards.
The installation of this new tenant not only confirms the park’s success but also enables Biocitech to expand the range of services it offers to the biopharmaceutical industry downstream from its medical research-and-development activities. These services now include the transport of biologicals in optimum conditions and the development of packaging methods that comply with current standards.
Experts reach agreement on important attributes of combination therapies for asthma
The agreement will provide physicians with much needed guidance for choosing the best combination therapy for their asthma patients
Data presented today at the World Allergy Organization (WAO) International Conference have shown that: clinical efficacy, safety, tolerability and speed of onset of a long-acting β2-agonist (LABA), potency of an inhaled corticosteroid (ICS), and flexibility of dosing are the most important attributes that influence an expert’s choice of a combination therapy to treat asthma.1 This study, undertaken under the auspices of the Global Allergy and Asthma European Network (GA2LEN), used the Delphi process, a validated consensus-development methodology that enables a group of experts to deal with a complex problem through rounds of structured feedback.
‘‘Given the lack of clear guidelines on selecting a specific ICS/LABA therapy for asthma and the absence of conclusive evidence supporting differences in clinical efficacy between the available combinations, this consensus has the potential to provide physicians with better direction and confidence when choosing the best option for their patients”, commented Professor David Price, Centre of Academic Primary Care, University of Aberdeen, UK.
Data presented today at the World Allergy Organization (WAO) International Conference have shown that: clinical efficacy, safety, tolerability and speed of onset of a long-acting β2-agonist (LABA), potency of an inhaled corticosteroid (ICS), and flexibility of dosing are the most important attributes that influence an expert’s choice of a combination therapy to treat asthma.1 This study, undertaken under the auspices of the Global Allergy and Asthma European Network (GA2LEN), used the Delphi process, a validated consensus-development methodology that enables a group of experts to deal with a complex problem through rounds of structured feedback.
‘‘Given the lack of clear guidelines on selecting a specific ICS/LABA therapy for asthma and the absence of conclusive evidence supporting differences in clinical efficacy between the available combinations, this consensus has the potential to provide physicians with better direction and confidence when choosing the best option for their patients”, commented Professor David Price, Centre of Academic Primary Care, University of Aberdeen, UK.
Improving diagnosis of Aspergillus bronchitis in patients with cystic fibrosis
At the annual British Thoracic Society meeting in London on December 1st, Dr Caroline Baxter reported the highly sensitive performance of Myconostica‘s real-time PCR assay MycAssay Aspergillus in cystic fibrosis (CF) sputum1 which is 260% more sensitive than the currently used culture. PCR combined with Aspergillus IgG testing on blood was diagnostic for the recently recognized condition in CF – Aspergillus bronchitis, described in 2006 in Leeds for the first time2.
CF affects about 1 in 2500 babies in the UK and leads to a lifetime of lung infection. Aspergillus infection in CF is associated with more rapid lung function decline, and an earlier need for transplantation or death.
CF affects about 1 in 2500 babies in the UK and leads to a lifetime of lung infection. Aspergillus infection in CF is associated with more rapid lung function decline, and an earlier need for transplantation or death.
William Vickery joins Hybrigenics as Head of Corporate and Business Development
Hybrigenics, a bio-pharmaceutical group with a focus on research and development of new cancer treatments and a fully-owned subsidiary specialized in protein interactions services, today announces it has hired William Vickery as Head of Corporate and Business Development, a newly created position.
William worked for five years at ExonHit Therapeutics as Senior Director of Business Development. During this time, he negotiated multiple extensions to ExonHit Therapeutics’ strategic partnership with Allergan, secured it’s participation in PharmaCog (the European Innovative Medicines Initiative consortium on Alzheimer’s disease) and in-licensed a breast cancer diagnostic discovered by Gustave Roussy Institute.
William worked for five years at ExonHit Therapeutics as Senior Director of Business Development. During this time, he negotiated multiple extensions to ExonHit Therapeutics’ strategic partnership with Allergan, secured it’s participation in PharmaCog (the European Innovative Medicines Initiative consortium on Alzheimer’s disease) and in-licensed a breast cancer diagnostic discovered by Gustave Roussy Institute.
Kits for accurate and reproducible mRNA amplification
Based on a unique non-Eberwine method using patented TRinucleotide primers and reagents - ExpressArt minimizes loss of sequence associated with two round amplification procedures and eliminates 3' bias in amplified products. The resultant RNA produces accurate data on differential expression of low copy number genes that fail to give sufficient signal intensities using alternative methods, allowing direct comparison of data from a wide range of input sample sizes. In addition using this exclusive primer technology - ExpressArt is able to amplify severely degraded RNA sequences enabling accurate analysis of RNA with extremely poor RIN values.
An optimized ExpressArt kit is available that allows specific amplification of bacterial mRNA from any species without the need for additional procedures to deplete ribosome RNA. Together with amino-allyl labeling modules and exclusive reagents for enhancing RNA isolations from very small and FFPE samples, ExpressArt provides solutions to problems no other amplification technology has overcome.
AMS Biotechnology (AMSBIO)
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