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GENTAUR Europe

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Voortstraat 49, 1910 Kampenhout BELGIUM
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Gentaur Bulgaria

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    Bullous pemphigoid is a subepidermal blistering disorder associated with tissue-bound and circulating autoantibodies directed mainly to the hemidesmosomal component collagen XVII. While recapitulating the main immunopathological features of the human disease, frank skin blistering does not develop in the absence of skin rubbing in experimental pemphigoid models that have been established in neonatal mice.

    Moreover, due to their experimental design they only allow for short-term disease observation. In the present study we aimed to establish a model that reproduces the frank skin blistering seen in patients and allows for longer observation times.

    Methods: Rabbit and sheep antibodies specific to several fragments of collagen XVII were generated and the purified antibodies were passively transferred into adult mice.

    Results: Collagen XVII-specific IgG bound to the basal membrane of the skin and mucous membranes activating murine complement in vivo.

    Mice injected with collagen XVII-specific antibodies, in contrast to mice receiving control antibodies, developed frank skin blistering disease, reproducing human bullous pemphigoid at the clinical, histological and immunopathological levels. Titres of circulating IgG in the serum of mice correlated with the extent of the clinical disease.

    Mice receiving sheep antibodies specific to murine collagen XVII showed an early onset and a more active disease when compared to litter mates receiving specific rabbit antibodies.

    Conclusion: This novel animal model for bullous pemphigoid should facilitate further investigations of the pathogenesis of bullous pemphigoid and the development of innovative therapies for this disease.

    Millions of lives have been changed over the past fourthy years because of advances in medical technology. From stem-cell research to reengineering the way we take our daily medications, all these developments have brought health care into the 21st century. There has been a vast disconnect between these improvements and the manufacturing processes used to provide influenza vaccines to the public.

    Shockingly, the method used to produce the influenza vaccine has not been significantly transformed since 1931, when vaccines used for preventive care were first introduced to the public.

    Influenza causes between 3,000 and 48,000 deaths and 190,000 hospitalizations in any given season, so it is critical to utilize the most effective production methods to create influenza vaccines to protect our communities. Until recently, all influenza vaccines available in the U.S. were produced by growing and harvesting the virus in chicken eggs. During the time this method has been successful, millions of eggs are needed to produce enough vaccine for our communities each year, requiring production to begin many months in advance. Once the virus strains are selected for the upcoming influenza season by the WHO (World Health Organization), and companies begin manufacturing the vaccine, it can take anywhere between 6 and 9 months to make the vaccine available to physicians or pharmacists.

    The egg-based manufacturing process has been working for us to date; however, there is a new process that raises the bar in influenza vaccine manufacturing, is less time-consuming and brings the manufacturing process into the digital age.

    Cell-culture technology is the latest production technique for influenza vaccine manufacturing, which involves growing the virus in cells from mammals, rather than chicken eggs. This method offers advantages over the conventional egg-based process:

    • Since no eggs need to be collected, vaccines can be produced and available to the public quicker, which is critical in case of a flu pandemic.

    • The process does not use any preservatives or antibiotics during production.

    Cell-culture technology has been successfully used to manufacture many other vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella and hepatitis A. This technology also has been tried and tested in other countries, which have already approved and use cell-based influenza vaccines abroad. Recently, the FDA gave its stamp of approval to use the technology in influenza vaccines available in the U.S., with an approval of a cell-based seasonal influenza vaccine.

    It is important that such a fundamental vaccine that every American ages 6 months and older is advised to receive each year is available using the most cutting-edge technology. I am excited to see how this major advancement will help start a new chapter in the evolution of influenza prevention.

    In an approach with the potential to aid therapeutic vaccine development, Whitehead Institute scientists have shown that enzymatically modified antibodies can be used to generate highly targeted, potent responses from cells of the immune system.

     

    The approach, referred to as "sortagging," relies on the bacterial enzyme sortase A to modify antibodies to carry various payloads, such as peptides, fluorophores, lipids, fluorophores, and proteins. In this case, the scientists, whose findings are reported online this week in theProceedings of the National Academy of Sciences, attached a variety of small antigens to an antibody directed at the surface of key immune cells. Through sortagging, the scientists were quickly able to prepare various antibody-antigen fusions and to deliver the antigens to their intended targets and track them as the immune cells mounted their intricate responses.

    "Sortagging is remarkably specific and efficient," says Lee Kim Swee, a researcher in the lab of Whitehead Member Hidde Ploegh. "We were able to create 50 different constructs (antibody-protein attachments), which wouldn't have been feasible if we had relied on the more traditional approach of genetic fusion."

    Swee and colleagues tested the approach in a mouse model of herpes virus, sortagging 19 known viral epitopes to a cell-specific antibody. They created a vaccine cocktail and immunized a group of mice. Upon subsequent re-exposure to the virus, vaccinated mice showed a 10-fold reduction in the amount of circulating virus.

    "This is proof of principle that one could in fact use sortagging on antibodies to easily attach a tailored set of antigens, toward which the immune system can be educated," Swee says. "This technique also helps us understand how to design better antibody-based vaccines."

    For paper co-author Carla Guimaraes, sortagging's value is bolstered by its flexibility. She likens it to "playing with Legos," because it allows "you to mix and match" proteins of diverse shapes, sizes, and functions. The process can be used, for example, to attach the relatively large green fluorescent protein (GFP) to antibodies without hindering GFP's desirable fluorescing activity or the binding of the conveying antibody to its intended target.

    "Imagination is really your only limitation," says Guimaraes, who is also a postdoctoral researcher in the Ploegh lab. "You could for example, use sortase to attach a toxin to an antibody and use that antibody to deliver the toxin to specific cells." Such an approach, she notes, would be an appealing strategy for developing better-tolerated cancer therapies.

    Hidde Ploegh's primary affiliation is with Whitehead Institute for Biomedical Research, where his laboratory is located and all his research is conducted. He is also a professor of biology at Massachusetts Institute of Technology.

     

    Further research conducted for the annual 2013 Cell Line Development & Engineering conference in Vienna next February, showed major developments in cell culture systems have given biotech's and pharmaceutical companies more flexibility to scale up cells to a high manufacturing quality.The production of high-performing cell lines have been enabled by cell engineering tools and this has only been possible through improvements in cell culture media.

    For best accommodation of these new developments, Informa Life Sciences' have expanded the programme to cover the latest in cell line development strategies and improvements in cell culture systems. Alison Porter, Head of Cell Line Development in the Mammalian Cell Culture group at Fujifilm Diosynth Biotechnologies (FFDB) clarifies how "For first in human studies with cell line construction on the critical path, it is vital to have optimised the early stages of cell line development. This can improve the future success of a biotherapeutic, both in terms of having the 'best' cell line and meeting increasingly tight timelines."

    Further feedback from over 50 industry professionals and academics also highlight additional trends such as high throughput screening of cell lines, Quality by Design applications, cell line development strategies for novel products, analytical tools for product evaluation and bioinformatics applications.

    Informa's annual 2013 Cell Line Development & Engineering conference has been designed to address topics essential to improve product development and quality. Susanna Benaim Conference Producer at Informa Life Sciences explains "The event uncovers the essentials in micro-scale system application, CHO genome sequencing, cell line engineering and targeted integration. The conference brings together leading experts from protein engineering, cell biology, cell line development and bioprocess, from both the pharmaceutical industry and academia. Any company specialising in this area is encouraged not to miss out."

    PerkinElmer, Inc., a biotechnology company, on 25 December last year has launched a new range of assay kits utilizing AlphaLISA technology for improving the safety testing, manufacturing and quality control of biotherapeutic drugs.

    "PerkinElmer is continuously seeking new ways to improve human health through the development of innovative technologies," said its President - Kevin Hrusovsky. "Adverse reactions due to drug toxicity are a real issue that we are passionate about helping to minimize. We are very excited to enable our customers to improve the safety and efficacy of new biotherapeutic drugs being developed through our new assay kits which are the latest addition to our growing biotherapeutics portfolio."

    This kits use the AlphaLISA technology of PerkinElmer's  to achieve higher quality results than the comparable ELISA (enzyme-linked immunosorbent assay) technology in half the time, for accelerating the drug discovery process, the company said.

    AlphaLISA technology also has a protocol with fewer assay steps compared to standard ELISA, resulting in better inter-assay and intra-assay precision, improved coefficient of variations (CVs), and easier method transfer to downstream departments due to variability reduction.

    Pina Fratamico is on the way to find the easiest and fastest way to test for harmfulEscherichia coli in ground beef. She explores using a next-generation real-time polymerase chain reaction (PCR) system to discover specific gene targets that indicate the presence of dangerous foodborne pathogens. The results show that assays performed using this PCR system are rapid, sensitive, and reliable.

    "Testing using these types of systems is faster, easier, and more reproducible than previous methods, and this should increase food safety in the long run. I feel that we could confidently move to these new systems for screening ground beef and other foods for E. coli contamination," says Fratamico, researcher at the USDA Agricultural Research Service in Wyndmoor, Pennsylvania.

    Certain strains produce a potentially dangerous toxin called Shiga toxin, but not all E. coli are dangerous. These Shiga toxin-producing E. coli also known as STEC can be found in raw meat and cause serious food poisoning in humans. According the FSIS - Food Safety and Inspection Service website, in October 2012 over, 2,300 pounds of ground beef were recalled due to contamination with STEC.

    "Certain groups of STEC have been declared as adulterants by the USDA FSIS, and the availability of rapid and reliable tests for these pathogens is critical so that testing results are available before meat is shipped to restaurants and consumers," she explains.

    In the meat industry the PCR protocol has already been used for some time. The genetic test detects the presence of specific gene targets that indicate the existence of STEC in meat. The new generation of real-time PCR systems, like the GeneDisc from France used in this particular study, employ a self-contained unit that standardizes the procedure and tend to be relatively portable and easy to use - offering obvious advantages for both meat processors and inspectors from the industry and government alike.

    Immunomedics, Inc. is a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. On 21 of December they announced that it has received notice that their patent application for "Anti-CD19 antibodies," will issue as US patent No. 8,337,840 really soon. The claims, allowed under the patent cover the use of specific humanized anti-CD19 monoclonal antibodies and fragments thereof for the treatment of autoimmune diseases. The fragments and antibodies thereof can be used alone, conjugated to at least one therapeutic agent or in combination with other humanized, chimeric, human or murine monoclonal antibodies, such as antibodies reactive with CD20, CD22, CD74 or HLA-DR. The patent, which provides coverage until 2024, also protects (19)-3s, a novel T-cell redirecting agent made as a DOCK-AND-LOCK™ (DNL™) complex using the Company's patented platform technology. The DNL™ complex recognizes CD19 on B cells and binds to CD3 on T cells. At last year's Annual Meeting of the American Society of Hematology (ASH), (19)-3s was reported to bind to T cells and non-Hodgkin lymphoma (NHL) cells simultaneously, and induce T-cell-mediated killing of NHL cells at less than 1 picomolar (pM) concentrations in an ex vivo setting, with maximal activity at 10 pM.

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