Category Archives: Biotechnology

Biopharmaceutical, Biotech, Biotech Services, Biotech Solutions, Biotechnology, Healthcare, Online, Pharmaceuticals, Science

Assay-Ready Chemistry Partnership between Enamine and Molplex

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Molplex and Enamine today announced a new partnership to offer the Enamine screening collection of 1.8 million stock chemicals through the Molplex online drug design and assay-ready chemical supply services. The agreement is a major step towards eliminating the high start-up costs ofdrug discovery, bringing sophisticated drug design, compound management and assay-ready chemistry to the world’s drug discovery scientists on demand. The agreement adds Molplex online drug design systems to the deep experience in organic chemistry and compound management of Enamine to solve the problem of generating viable chemical leads for novel targets.

Molplex CEO David E. Leahy said: “We are very proud to be selected by Enamine as their partner for on demand drug discovery services at a time when major restructuring of the industry is creating new opportunities and new markets for our combined expertise. This agreement marks a step change in the size and scope of our assay-ready chemical supply service and major progress towards our goal of being the world’s first choice partner for enabling the long tail of drug discovery”

Enamine Chief Marketing and Sales Officer Dr Vladimir Ivanov said “We are happy to partner with Molplex and supply our products to the highly integrated drug discovery platform they maintain. In this collaboration we deploy all our discovery resources including the world’s biggest screening collection (1.8 million compounds), largest inventory of building blocks (45,000 products), and over 300 chemists at our Kiev’s site to assure high cost efficiency and high responsiveness to any follow up chemistry emerging from projects run through Molplex discovery platform.”

Via EPR Network
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Gene Therapy and Stem Cell Therapy Standard Developed For A Unique Derivative Of Post Hetero-Plastic Inplantation Chronic Inflammation Syndrome, The NIDO Disease

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Researchers task force, led by faculties of T-Protocol, registered Genom Project as controlled genom project in the hosted database of NCBI, a publication matter authority and function assigned organization under oversee of Department of Health & Human Services, reached once to share the exegetical impression officially pre-published concerning the understanding specific spectrum of symptoms covering boroad range of character usually complained and observed through chronic inflammation, granuloma, some types of lymphoma and various uncommon symptoms to let physician scientists suspecting indicium of neurological diseases, NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome and setting Massachusetts indications of treatments standardized manual (Massachusetts manual) & diagnostic and standardized medical treatment manual for post hetero-plastic inplantation chronic inflammation syndrome, specific edition against NIDO Disease.

The once defined causes of NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome are considered each of a common living organism to cause conformational diseases like Creutzfeldt-Jakob disease, Alzheimer’s disease, Parkinson’s disease, Huntington’s disease and kinds of and a set of biochemical and physical reaction and response realized by cross-species gene- mutation, as biotransformation, easily describing natural physiological and biochemical changes in vivo substrate of human bodies. After this studies, standardized protocol of gene therapy and applied stem cell therapy is now in practice and on available.

Faculties,committing themselves entirely to the project, of each institutes and organizations participating the project to ascertain proteins and DNA/genomic DNA/genom of human, other mammal and virulent microorganism including bacillus/virus affecting each symptom and the symptoms’ spectrum expressed generally and observed commonly on patients suffered from NIDO disease, extraordinarily unique derived type of post hetero-plastic implantation chronic inflammation syndrome and to develop diagnostic standard and treatment protocol standardized and to find a clue compose gene therapy protocol and applied stem cell therapy protocol to entirely heal NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome and to let all of current suffered patients from various combined symptoms directly derived by chronic inflammation and various tumors, have to express full surprise at the fact that these disease and patients suffered are made up and left no attention and no relief.

Via EPR Network
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Nationaly Registered T-Protocol Of Genom Project Successfully Applied To Retrieve Bio Mechanism Of Hair Regrowth

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Division of Gene Medicine & Stem Cell Application, School of Medical Science, complete the research and established completely new protocol totally recovering natural bio mechanism of hair regrowth.

The researchers, led by Lord. Prof. Dr. Daichent Otto Rie, specified protein and genom to affect internal bio mechanism to generate hair and control the level of successful growth being low which is the baldness.

The key cast of the set of the bio cycle is hair follicles, which is stem cell on head skin and effect or holding function to cure many neurotic diseases and disorders like Alzheimer’s disease – Prion Disease and even Trion Disease (Post Hetero-Plastic Implantation Chronic Inflammation Syndrome; PhCIS) has absolutely unique character being retrieved absolute stem cell, which can recover the ability as stem cell after got adult. The key genom and DNA has been found through the Genom Project’s T-Protocol research developing in the government registered Genom Project since 2005. The most concentrated attention of researchers is not “what is cause” but “What protocol is best”.

The team of Prof.Daichent has successfully completed in vivo and in vivro experiment actually using voluntary patients whose types of hair loss being across over highly wide range extent to even lymphoma and cancer and finally established next genetic hair loss curing treatment protocol mainly composed of stem cell therapy and gene therapy.

Most of cases are treatable through entry level stem cell theraputic technique or HIV-1 Vector using high level technique but A20 introduction as gene therapy is required when treating patients being suffered from lymphoma, cancer or any neurotic diseases like Alzheimer’s disease – Prion Disease and even Trion Disease (Post Hetero-Plastic Implantation Chronic Inflammation Syndrome; PhCIS).

As Prof.Daichent points since 2005 being on School of Public Health of Harvard, in the treatment manual (published 2005), the key factor to overcome of lymphoma and chronic inflammation on human skin is extraordinary redundancy coding of polyglutamine DNA synthesis as the type of disease caused by pathological proteins and lack or heavy impairment of an specific DNA of A20.

Actually, the treatment protocol curing for baldness is also found through T-protocol which was essentially aimed at achieving causal and complete treatment of lymphoma, cancer, chronic inflammation and many neurotic diseases. Under control over the T-Protocol, all of clinical practitioner must always keep their eyes on the fact of using steroid is taboo over administration so being strictly prohibited. And also the technique must be under control of the competent faculty accredited by board in accordance with Europ.Gene Institute or specifically set physically area solely for research and clinical practice of nations like Switzerland, Germany, India, Hongkong, U.K. territories (NEVER inside U.K.) appointed by protocol developer and assigned practice entity.

Via EPR Network
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Drug Discovery On Demand By Molplex

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An innovative new online “drug discovery on demand” platform has been launched by Molplex, a company specializing in products and services for the life sciences. Designed to help drug discovery groups working anywhere in the world, it aimsto eliminate the high start-up costs and minimize the financial risks traditionally associated with inventing new medicines.

Molplex CEO David Leahy said: “As the pharmaceutical industry changes, a new ecosystem of small, flexible teams operating as “Micro Pharmas” is emerging. Molplex will provide the services they need to succeed at inventing better medicines at lower cost”.

The first version of the new Molplex system launched today offers free access to sophisticated drug design systems, high quality assay-ready stock chemicals and high content biological screening at www.molplex.com.

Via EPR Network
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Turkey’s Biopharmaceutical Sector Attracts, Boosts Research and Development Expenditures

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A recent report on the biopharmaceutical sector presence, employment, economic output and research and development activity in the European States highlights Turkey’s long-term prospects for growth. The report notes that the industry is creating a positive ripple across the region’s economy, improving the quality of life for its citizens and increasing access to medicine.

In particular, strong public-private industry collaborations and an emphasis on research and development are highlighted as aiding in the development of new medicines, improving access to medicine and increasing the economic benefits of the region. Güler Hülya Yılmaz, head of Deloitte Turkey’s Health and Drug Industry division, emphasizes the importance of research and development (R&D) in the biopharmaceutical sector. Yilmaz states, “In R&D, it’s important that there be a strong foundation for laying the bricks of innovation. Turkey has that foundation, but with this there is a need for government support of new research and partnerships between industry and academia.”

Global Health Progress (GHP) also believes proper support for research and development in the pharmaceutical industry can contribute to the Turkish economy far beyond drug development and production. For example, the Turkish biopharmaceutical market has expanded rapidly, generating approximately US $8.5 billion in revenue in 2008 and contributed thousands of high-quality, highly skilled jobs to the region. Fortunately, recent reforms and policy changes by the Turkish government have created a more favorable environment for R&D investment. For example, the Turkish government has implemented a number of Technology Development Zones, which feature exemptions from income and corporate taxes on profits derived from R&D activity, an exemption from taxes on the wages of R&D personnel employed in the zones and value added tax (VAT) exemptions, all through 2013.

Additionally, the country’s sizeable pool of patients for clinical trials can bring health benefits, diffusion of medical knowledge and greater patient access to medicine and high quality care to citizens. With a population of approximately 72 million and a growing middle class, chronic diseases represent the majority of Turkey’s disease burden. An increased focus on prevention, early intervention, new treatments, and public-private partnerships, including recent government, university and industry collaboration facilitated by the establishment of several research institutes, is critical to reducing the health and economic burden of disease in Turkey.

Via EPR Network
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The Porcine microRNAome is Revealed

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Researchers from LC Sciences LLC and a collaboration of Universities1 have established a porcine microRNAome, a complete catalog of all microRNAs expressed in the species Sus scrofa2. MicroRNAs (miRNAs) are small regulatory RNA molecules known to control a wide array of cellular functions such as growth and development and whose dysregulation has been associated with disease. The findings of this study lay the groundwork for a greater understanding of the species through further mapping of tissue- and stage-specific miRNAs.

The domestic pig is an important species from various standpoints. First, it is a major protein source in the human diet world-wide. Additionally, its anatomy, physiology, and genome size are very similar to the human species, and there has been increasing molecular genetic evidence showing the comparability of human and pig, making it a suitable model system for human biology. Pigs are now model animals for biomedical research of cardiovascular, immunological, cancer, diabetes, and a range of other diseases. Finally, the pig has become an important source of organs and tissue for transplantation into humans.

Prior to this study, miRbase3, the primary public repository for miRNA sequence data, listed only 73 unique pig miRNAs, this out of a total of 10,883 database entries encompassing over 100 species. The number of miRNAs for pig was significantly lower than for other species with similar size genomes (such as Human with 894 miRNAs) suggesting the existence of far more pig miRNAs.

The researchers used advanced deep sequencing and developed bioinformatics technologies to analyze all the small RNA molecules that are transcribed from all the genes in the pig genome. After filtering, mapping, alignment and classification of all the reads, they had shown that the pig miRNAome has 777 unique miRNA sequences. The sequencing results will not only greatly enhance the utility of the pig microRNAome as the blueprint of advanced pathway network studies of miRNA and their target mRNAs, but also provide information on time-dependent variations of the microRNAome as to sequence lengths, counts, composition, genomic location, and the relative expression of conserved versus pig-specific miRNAs.

Via EPR Network
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Cryo-Cell CEO Mercedes Walton Invites Women to Share Their Ideas on Self-Care and the Power of Stem Cells

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Cryo-Cell International, Inc. a global leader in stem cell innovation, resolves to help women inspire and empower each other to take charge of their health in the New Year, and to spark conversations about the promise of stem cells.  The company will be accepting video entries for its “Resolution Revolution” contest through January 31, 2010, and details on the event can be found at www.celle.com/resolution.

“This time of year, we often make New Year’s resolutions to take better care of ourselves, but the dawn of a new decade is particularly poignant as we look ahead with hope and inspiration at the steps we can take,” said Mercedes Walton, CEO of Cryo-Cell International.  “Never in history have we experienced a time of such rapid advances with stem cells, including the use of menstrual blood stem cells and how they may help women protect their health” she added.  “Because women often look to each other for information and inspiration, we’re looking to empower them to spread the word through video about what the power of stem cells means to them.”

The C’elle service is the first and only one of its kind, empowering women to collect and cryo preserve stem cells from their menstrual flow.

Stem cells from menstrual blood are proven to be a rich source of stem cells which proliferate rapidly and have the ability to become many different types of cells such as cardiac, neural, bone, fat and cartilage.

These stem cells are a potential source for promising regenerative therapies to treat stroke, cardiac, diabetes, breast cancer, spinal cord injury, chronic wounds, Alzheimer’s and other debilitating diseases.

Since launching its proprietary service, the company continues to expand research and development initiatives worldwide in order to accelerate the potential diagnostic and therapeutic benefits of these unique stem cells. Cryo-Cell partnered with the National Institutes of Health (NIH) Clinical Center, where research is underway to better understand the C’elle stem cells and their potential benefit for the treatment of breast cancer.  It also has entered research and licensing agreements with several other organizations to identify potential future diagnostic and therapeutic uses for endometriosis and stress urinary incontinence in women and regenerative medicine specific to wound healing. In 2009, the service was licensed in China, Thailand and Brazil.

Via EPR Network
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Cord Blood: Saving For The Future

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For an expectant mother, there are a million details to worry about and a lot of important decisions to be made.

Cord Blood: Saving For The Future

One of those decisions to be made is whether to bank your baby’s umbilical cord blood. Cord blood is valuable because it’s full of stem cells scientists and doctors can use in research and regenerative medicine.

“Cord blood stem cells are the ones that are obtained from the newborn. They’re closest in age to being an embryonic stem cell without being an embryonic stem cell,” said David Harris, PhD with Cord Blood Registry.

When they’re stored properly in a bank, like one in Arizona, the stem cells can be used to replace other cells in our bodies that may be damaged or missing due to disease. But, you only have one chance to harvest them.

“At the time of delivery, before the placenta is delivered, we have a little bag with a needle and a tube, like an IV tubing, and we actually draw the blood out of the placenta into a prepared bag and that’s what you send in to the cord blood banking people,” said Dr. Lynn Frame.

But, Dr. Frame says very few of his patients actually do it because of the cost.

Most private cord blood banks charge more than $1,000 up front. Then, for every year you store the blood in one of their cryogenic tanks, it costs about $100. For 18 years of storage, it can add up to about $3,000.

Via EPR Network
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Scientist Uses Stem Cells To Repair Heart

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Dr. Joshua Hare believes medicine is close to a goal long thought to be impossible: healing the human heart.

The way to get there? Stem cells.

“These could be as big as antibiotics were in the last century,” said Hare, who leads the University of Miami ‘s new Stem Cell Institute. “Stem cells have the potential to have that kind of impact. Diseases like heart attacks, strokes, kidney failure, liver failure — we will be able to transition them into things you live with.”

Hare spends his days peering through powerful microscopes, recruiting scientists from top universities and attending to patients betting on improving their conditions through his clinical trials.

Stem cells, only one-thousandth the size of a grain of sand, are the master cells of the body, the source from which all other cells are created.

The most basic are embryonic stem cells, which are “totipotent,” meaning they can divide into any other type of cell — heart tissue, brain tissue, kidney tissue — all 220 cells that exist in the human body. They’re controversial because when they are harvested, the embryo is destroyed, ending potential life.

But coming into view are new kinds of stem cells — immature adult stem cells that can be extracted from bone marrow, from organs such as the heart or kidney or even from the skin. These can be taken without destroying embryos.

While researchers until recently believed adult stem cells were limited because they could develop only into cells similar to them — bone marrow cells only into cord blood stem cells, for example — evidence is growing that they, too, may become the tissue for hearts, brains, kidneys and other organs.

Via EPR Network
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Will Intra-Osseous Injection of Umbilical Cord Blood Reduce Graft Failures?

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Researchers from Italy have reported that the injection of umbilical cord blood directly into the pelvic bones of patients with leukemia appears promising. These results were recently published in an early online publication of the Lancet Oncology on August 9, 2008.

Transplantation of bone marrow, peripheral blood stem cells, and umbilical cord blood is accomplished by intravenous infusion. The original studies of human bone marrow transplantation were carried out by direct infusion into bone marrow spaces. However, this approach was abandoned as there was no advantage in speed or rate of engraftment over intravenous infusion. Since these early days of transplantation, there have been sporadic attempts to evaluate intra-osseous infusion of stem cells, but no advantage over intravenous infusion was ever found. The reason for this is thought to be that direct infusion of stem cells into the marrow cavity is in fact identical to intra-arterial or intra-venous infusion, and most stem cells enter the general circulation before homing into marrow spaces throughout the body.

Umbilical cord blood transplantation is associated with relatively high graft failure rates thought to be due to the relatively low dose of stem cells in each collection. Researchers have suggested that the infusion of stem cells from two separate cord blood collections alleviates the graft failure problem. However, Italian researches have posed the question of whether or not intra-osseous infusion would be better.

The current trial evaluated direct infusion of umbilical cord blood into the pelvic bones. This trial included 32 patients with acute myeloid leukemia (AML) and 12 with acute lymphoblastic leukemia (ALL); median age was 36 years. Overall, 14 patients had advanced-stage disease that did not respond to standard therapies, and no patient had a suitable donor for the stem cell transplant.

Via EPR Network
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Now, Women Can Bank On ‘Monthly Miracle’ For Future Treatment

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Women in the city will soon have the option of banking their menstrual blood so that menstrual blood stem cells can be used for treatment of serious disorders through stem cell therapy.

In six months, Life Cell International, in technology partnership with Cryo-Cell International, will set up the facility, which will be the first to store menstrual blood in the country.

Cryo-Cell, which has patented technology to decontaminate samples, started menstrual blood banks in the US last year, and other countries are yet to catch up. Cryo-Cell calls it ‘your monthly miracle’. The endometrium-lining of the uterus regenerates every month, suggesting the presence of stem cells. However, there is no published scientific work on the curative properties of such cells.

Stem cells have the ability to regenerate themselves through cell division and act as a repair system for the body. Research on stem cells provides knowledge about how healthy cells replace damaged ones in adults, leading to the possibility of cell-based therapy to treat diseases.

“Menstrual blood contains millions of stem cells that have many properties and characteristics similar to those of stem cells found in bone marrow and embryos. These stem cells exhibit capabilities for self-renewal and multi-potency,” says LifeCell International executive director Mayur Abhaya. Stem cell research hopes to find answers to problems such as cardiac and degenerative diseases, besides cancer.

The women would be given a collection kit comprising a menstrual cup and collection tubes. The blood would be processed and preserved in liquid nitrogen at extremely low temperatures.

Though the Chennai bank has not decided on the rates, it hopes registration will cost less than that charged for preserving cord blood. At present, the bank, which has stored over 13,000 samples of cord blood at a facility near Chennai, charges Rs 41,100 for collection, processing and storage of the blood for the first year. From the second, the client pays an annual fee of Rs 3,500 to preserve the blood for two decades.

The biggest advantage of menstrual blood, according to LifeCell chief scientific officer Dr Ajit Kumar, is that it can be easily harvested in a painless, non-invasive manner. “And it also extends the scope of stem cell therapy to a larger section of the people. Cord blood is an option open to only those who are pregnant or those planning babies,” he says.

At a time when legal restrictions on collection of embryonic stem cells have been stymieing research, the option to save menstrual blood is a boon because these cells have similar properties to that of cord blood, he adds.

Via EPR Network
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New Transplant Therapy, Shift in Drug Discovery

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On August 23-25, 2010, industry scientists, CEOs, and academics will convene at Philadelphia’s Four Seasons Hotel for the “Ubiquitin Drug Discovery and Diagnostics Conference” to discuss the Next Big Thing in drug discovery research—the ubiquitin pathway. Advances in oncology, infectious diseases, neurodegeneration, inflammation, diabetes, and muscle wasting will be covered.

New Transplant Therapy, Shift in Drug Discovery

A pathway is a sequence of reactions converting one molecule into another. Ubiquitin, which is a small protein, is used often to mark larger proteins within a cell for breakdown. This pathway plays fundamental roles in human health and disease; many human pathologies have been linked to changes in ubiquitin pathway enzymes. Attracting experts in this growing field, the three-day conference is unique in its focus on drug discovery within the ubiquitin pathway.

Rejection hurts; but for the recipient of organ donation, rejection can be fatal. New combination therapies for treating antibody-mediated rejection (AMR) in transplant patients are possible, thanks in part to manipulation of the ubiquitin pathway.

When a transplant recipient’s body rejects donor tissue, the recipient’s plasma cells, which typically fight off infection, are in fact the aggressors in the attack. Dr. Woodle suggests stalling the proteasome (or “cellular waste-bin”) via the ubiquitin pathway (or “cellular tagging and shipping information hub”) thereby depleting plasma cells and treating rejection. Dr. Woodle will present his latest findings during the final conference session.

Via EPR Network
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Website Recognizes Benefits of Biotech Crops

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A new website by The United Soybean Board (USB) highlights the important role biotechnology plays in allowing U.S. farmers to continue to meet the world’s food demand as well as ensuring our environment and food supply remains as safe as ever. Whether you know it as biotech, genetically modified or GM—the technology that allows farmers to grow more per acre with fewer inputs plays a critical role in feeding our growing world.

Website Recognizes Benefits of Biotech Crops

Biotechnology allows researchers to select the desired characteristics in a variety of seeds and crops, resulting in improved nutrition, increased pest and disease resistance and greater crop yields. This technology enables farmers to generate a sustainable supply of food, feed and fuel for customers here at home and abroad.

Click here for additional information on biotechnology.

About the United Soybean Board
The United Soybean Board (USB) represents a group of volunteer farmer-leaders administering a U.S. soy research and promotion program known most commonly as the “soybean checkoff.” Through the soybean checkoff, U.S. soybean farmers invest a portion of their sales in research and promotion to provide food, feed, fuel and fiber to the world. By building demand for such things as soy biodiesel, soybean meal, soybean oil, soy exports and more, USB and the soybean checkoff help provide profit opportunities for all U.S. soybean farmers.

Via EPR Network
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Stem Cells From Menstrual Blood May Benefit Stroke Patients

Cryo-Cell International, Inc. today announced results of a study published [this month] in the cover article of Stem Cells and Developmentshowing that stem cells found in menstrual blood may one day be a potential source for stem cell therapies in stroke and other central nervous system disorders. Menstrual stem cells, known as MenSCs, offer an easily accessible, non-controversial and renewable stem cell source with the potential to one day treat a host of diseases, such as stroke, osteoporosis, Alzheimer’s and Parkinson’s disease, according to a number of early studies. The study, entitled “Menstrual Blood Cells Display Stem Cell-Like Phenotypic Markers and Exert Neuroprotection Following Transplantation in Experimental Stroke,” was conducted by researchers at Cryo-Cell International, the University of South Florida , Saneron-CCEL Therapeutics and the Medical College of Georgia.

Stem Cells From Menstrual Blood May Benefit Stroke Patients

Because the cell damage after an initial stroke episode occurs over an extended time, treatment strategies directed at quickly rescuing these nerve cells have the potential to slow the disease progression and possibly restore nerve function. In this study, researchers found that transplantation of MenSCs, either directly into the brain or peripherally, significantly reduced behavioral and histological abnormalities, suggesting that the MenSCs had a protective effect on brain cells, averting further apoptosis, or cell death, and potentially reversing the neural trauma experienced during a stoke.

“The data shows immediate behavioral recovery at an early period after transplantation although the exact mechanism underlying the neural benefits of MenSCs remains unknown,” said lead researcher Cesar V Borlongan Ph.D., Professor and Vice-Chair of Neurosurgery and Brain Repair at the University of South Florida Health . “ We do know that several trophic factors have been identified post transplant that may potentially point to a secretion of therapeutic substances from MenScs versus one of cell replacement. Equally important, is that there was no instance of complications or negative effects such as detectable tumor, ectopic formation or overt graft-versus-host in any of the transplanted animals.”

During the study, the investigators analyzed shed menstrual blood and tissue to identify MenSCs. The samples were obtained using a menstrual cup and transferred to a laboratory for processing and cryopreservation. After inducing a simulated stroke (oxygen glucose deprivation, OGD) on adult rats, the researchers injected the rats withmenstrual blood –derived stem cells and found that those who were exposed to MenSCs exhibited a significantly reduced death rate. Behavioral assessments of motor coordination and neurological function were performed on the rats 14 days after stroke-transplantation and indicated improvements in both motor and neurological abnormalities.

“Compared to other stem cell sources, such as bone marrow and umbilical cord blood , MenSCs are harvested from a readily available and renewable source of adult mesenchymal stem cells. These novel and highly prolific stem cells are easily obtained using non-invasive methodology and create the potential for matched cell transplantations in large scale clinical trials,” said Julie Allickson, Ph.D., study investigator and Vice President, Laboratory Operations, Research and Development at Cryo-Cell International, Inc.

The benefits of stem cells derived from menstrual blood were first indicated in a study sponsored by Cryo-Cell that was published in Cell Transplantation in April 2008. That study demonstrated that MenSCs are stromal stem cells, meaning they have the capability to differentiate into important cells, such as such as bone, cartilage, fat, nerve and cardiogenic cells.

“Stroke is the third leading cause of death and disability in U.S. adults,” said Mercedes A. Walton, Cryo-Cell’s Chairman and CEO . “According to the American Heart Association, stroke will cost almost $68.9 billion in both direct and indirect healthcare costs in 2009. In view of these statistics, we are clearly encouraged by research study results that demonstrate significant promise for the development of regenerative medicine therapies to potentially treat and manage the debilitating conditions caused by stroke and possibly other neurological disorders.”

The Celle SM service is based on Cryo-Cell’s expansive IP technology portfolio and was introduced in November, 2007 as the first and only service that empowers women to collect and cryopreserve menstrual flow containing undifferentiated adult stem cells for future utilization by the donor or possibly first-degree relatives in a manner similar toumbilical cord blood stem cells. Based on the continued success of MenSCs in the research setting, Cryo-Cell is actively expanding its portfolio of research collaborations with world renowned scientists committed to study this novel stem cell population for a broad range of regenerative therapeutic development.

Via EPR Network
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LC Sciences Pairs Deep Sequencing with Customized Microarrays to Offer New Seq-Array Service for Discovery & Profiling Applications

LC Sciences today announced the launch of its new Seq-Array(SM) services designed to take full advantage of both the latest deep sequencing capabilities and the proven genomics tool – microarray. This combination of technologies advances microRNA research to the next level of depth and understanding that was not possible before with either of the technologies alone. LC Sciences has been a leading provider of microRNA discovery and profiling services since 2005.

LC Sciences Pairs Deep Sequencing with Customized Microarrays to Offer New Seq-Array Service for Discovery & Profiling Applications

microRNA is a young, dynamic field of study and though significant discoveries are being made every day, the very complex regulatory mechanisms of these small RNAs are still not fully understood. Continued advancement requires adaptable, even customizable research tools that can keep pace with the rapidly advancing research in this field. While deep sequencing yields results that broadly cover genome-wide miRNAs from samples of various origins, the relatively high cost and low throughput nature of sample handling, makes the systematic follow through of the sequencing discoveries for validation and/or profiling in a reproducible manner time consuming and expensive. Microarrays have achieved wide acceptance as the preferred tool to systematically profile and compare the gene expression of large numbers of samples rapidly, reproducibly, and cost effectively; however they are dependent on previously known sequence information. Seq-ArraySM is a combination of these technologies that maximizes the effectiveness of each method while overcoming the limitations of the other.

Seq-ArraySM for microRNA starts with exploratory small RNA deep sequencing of a single or mix of RNA samples to perform a broad search and generate a comprehensive atlas of all microRNAs within a given research study. Next, bioinformatics are employed to map the raw sequencing reads to a custom generated sequence database, classify and align all sequences and sequence variants, as well as to predict novel microRNAs. A custom SeqArrayâ„¢ microarray is designed based on the mapped novel microRNAs, the predicted novel microRNAs, and any previously described publicly available microRNA sequences. Finally, expression profiling of large numbers of samples on the custom array design together with additional bioinformatics work completes an efficient pathway to focused biological insights including: revealing regulatory target genes, defining gene expression pathways, and discovering biomarkers.

“We feel like this is a productive match of the two technologies,” says Dr. Christoph Eicken, Head of Technical Services at LC Sciences. “It’s something we have really already been doing for a while and thought it made sense to package together as a single service. Often times researchers come to us who are studying a non-typical species with very limited or no prior knowledge of microRNA sequences or function in their model system. By the end of the complete Seq-ArraySM project they have become the world authority on microRNA in their area of research. It’s been very exciting to be part of this.”

About microRNA – microRNAs are small non-protein-coding RNA molecules that function as negative regulators of gene expression by targeting specific mRNAs. This either inhibits translation or promotes mRNA degradation.

Via EPR Network
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Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

Catalent Pharma Solutions will host a free webinar featuring Principal Scientist, Alan D. Hendricker, Ph.D. The one-hour webinar provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission. The presentation, titled “Leachables and Extractables: Regulatory Context,” will be held on Thursday, March 18th from 2:00 p.m. to 3:00 p.m. EDT. To register for the webinar, please visit: https://www2.gotomeeting.com/register/290022131.

Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

The presentation will be beneficial to all managers, directors, and vice presidents of small and large pharmaceutical companies that are working in product development of all dosage forms. The regulatory documents covered will include those for MDI, DPI, nasal spray, topical, oral and parenteral drug products. Additionally, the webinar will explore other applicable guidance and recommendation documents including: ICH guidance, Product Quality Research Institute (PQRI) recommendations, and EMEA and FDA guidance on genotoxic and carcinogenic impurities. The webinar will conclude with direction on modern approaches to applying this information in an analytical laboratory.

Catalent Pharma Solutions provides expert extractables and leachables services to the pharmaceutical industry with a focus on applying their industry leading scientific, regulatory and compliance expertise to all dosage forms and drug delivery platforms. Participants can expect to learn from Catalent’s expertise in these areas and take away an understanding of regulatory documents surrounding extractables and leachables testings, modern approaches and strategies to these testings, and guidance in analytical laboratory actions.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Gregory T. Bleck, PhD. To Co-Chair Cell Line Development And Engineering Conference

Gregory T. Bleck, PhD., Senior Director of Cell Line Engineering for Catalent Pharma Solutions, will be co-chairing the Cell Line Development and Engineering conference being held in San Francisco, California on February 25-26, 2010.

Gregory T. Bleck, PhD. To Co-Chair Cell Line Development And Engineering Conference

In addition to co-chairing the conference, Dr. Bleck will be presenting “Characteristics of an Effective Mammalian Cell Line Generation Process for Bio-Pharmaceutical Production.” His session will explore how steps in the generation of mammalian cell lines have been optimized to make the process more efficient. Dr. Bleck will also outline certain approaches to improve timelines and throughput. Additionally, data collected f r o m Catalent’s development of more than 200 cell lines, each producing a different antibody or recombinant protein, will be reviewed.

Dr. Bleck received his BS and Ph.D. f r o m the University of Wisconsin-Madison, and performed postdoctoral work at the University of Illinois-Urbana working in the areas of gene regulation and expression, and joined Catalent Pharma Solutions in 1998. At Catalent, he transferred his knowledge of gene expression and transgenic systems to the development and continued optimization of retrovector expression systems and is one of the developers of the GPEx® gene expression technology. Dr. Bleck has published over fifty-five research papers and authored three book chapters. He has seven issued patents and eight patents currently under review.

For more information on Catalent’s broad range of biopharmaceutical development services, go to http://www.catalent.com/development.

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Maastricht University And PharmaCell Publish Results On Possible Improved Immune

In a collaborative publication in the prestigious journal Blood that appears this week, PharmaCell BV, the Maastricht University, Institute for Research in Biomedicine in Switzerland and the Research Center for Allergy and Immunology in Japan present data on a novel approach to improve treatment of acute leukemia patients. In a study that received a grant from the Dutch governmental organization SenterNovem, the consortium has shown that hematopoetic stem cells, commonly used in the treatment of those patients, can be cultured such that they show clear signs of an improved capacity to repair the immune system.

Maastricht University And PharmaCell Publish Results On Possible Improved Immune

Patients suffering from acute myeloid leukemia can be cured by hematopoetic stem cell transplantation, but many viral or bacterial infections occur after the treatment and are life threathening. The protocol developed by the consortium can potentially reduce the period after treatment that the patient is susceptible to such opportunistic infections.

The proposed treatment may greatly reduce morbidity and mortality in those patients. In the study that was conducted in mice, it was found that the stem cells treated with their protocol quickly migrated specifically to the thymus and matured there into effector cells of the immune system. Further research is needed to delineate the precise mechanism of action and to prepare the technique for application in patients.

Alexander Vos, CEO of PharmaCell comments: “The outcome of this projects shows the strength of consortia in which academia collaborates with industry. It has enabled us to keep a focus towards clinical application in a research project that had fundamental questions. As a company that focuses on the development and production of cell therapies, this research fitted very well in our profile. We are very pleased with the collaboration as well as with the outcome. PharmaCell intends to closely follow future developments in this project and will expertly support future clinical application of this cell therapeutic application where possible.”

Dr. Gerard Bos, who together with Dr. Wilfred Germeraad,is the lead investigator of the Division of Heamatology, Department of Internal Medicine of the Maastricht University Medical Center+ announces: “We believe that the potential of this technique to improve patient care is high. Further research is needed before application in patients is possible, but we feel very confident about that. The research has been carried out by a very strong international group of scientist and the results are convincing. We are looking forward to further developing the method.”

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Catalent Solidifies Inhalation Product Development Capabilities With New Offering

Catalent Pharma Solutions has acquired advanced fine powder filling capability, which solidifies Catalent’s position as a leader in development and manufacturing services to the pharmaceutical inhalation sector. With the purchase of Harro Höfliger’s Omnidose filling equipment, Catalent now offers its customers fully scaleable dry powder inhaler (DPI) filling capability. This widely-accepted technology, to be housed in Catalent’s Research Triangle Park, North Carolina facility, provides a flexible platform to reliably support all clinical manufacture through Phase II/III and a scaleable path to higher volume late stage clinical and commercial manufacturing.

The Harro Höfliger equipment is an advanced technology specialized in powder filling for microdosing, in the 1 – 300 mg of powder range, into an array of DPI formats to include both capsule-based and pre-metered blister device formats. This new capability gives Catalent a full range of pulmonary and nasal services, filling a gap in the marketplace for advanced powder filling capabilities. Catalent will now be able to serve as a one-stop-shop for the development of all inhalation dosage forms, possessing both the capital assets and technical experience. This recent addition complements Catalent’s pre-existing automated pMDI infrastructure.

Catalent’s primary location for inhalation product development is in Research Triangle Park, North Carolina where its experienced team offers comprehensive pulmonary and nasal services to help take a product from concept through regulatory approval. Catalent has extensive experience with all pulmonary dosage forms including pMDIs, DPIs, nasal sprays and solutions/suspensions for inhalation. For more information on Catalent’s proficiency in dosage form selection, technology assessment, formulation development, analytical testing and supplying toxicological and clinical trial materials, please visit www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Lead Immunogenicity Course

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will lead a two-day international course on immunogenicity. The course will take place at the Regus Victoria in London on Wednesday, December 2 through Thursday, December 3, 2009.

The interactive course, titled “Introduction to Immunogenicity,” will enable attendees to better understand ways to detect, reduce and characterize unwanted immunogenicity. Additionally, Menendez will aid in interpreting the latest regulatory guidelines, and will assist attendees in formulating a winning strategy to implement in their business immediately.

The sessions will include a formal presentation by Menendez followed by facilitated breakout groups where delegates will be given the opportunity to apply the principles taught in the sections. Case studies, cut-point exercises and protocol workshops will increase the participants’ hands-on experience in developing and validating sensitive and rugged methods to detect and characterize unwanted immunogenicity.

As part of Catalent’s Development and Clinical Services Segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menenedez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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