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GEN Online posts articles and columns from the print edition of Genetic Engineering & Biotechnology News. Read our acclaimed columns, including Wall Street BioBeat, FDA News & Analysis, Point of View articles by industry experts, and the ever popular Best of the Web bioscience website reviews, and learn about the new products that are fueling the industry.

Current Issue - Nov 1, 2009 (Vol. 29, No. 19 )


BIOBUSINESS

Feature Article

Point of View

  • Preserving the Integrity of Statistics
  • Zachary N. Russ
  • Ronald Coase, the Nobel Prize-winning economist, is commonly credited with the adage, “If you torture the data long enough, it will confess.” I was recently reminded of Dr. Coase’s astute observation while relaxing with a group of bio-buddies after a long day of tending liquid cultures. The conversation worked its way around to common frustrations in the lab—dying colonies, promiscuous antibodies, and, surprisingly, the question of statistics.

    ... more

Legal Affairs

  • Certainty Not Required for Inventorship
  • William L. Warren
    S.Alex Cao, Ph.D.
  • Modern life science research frequently requires collaborative research efforts between colleagues and even institutions. But which collaborators should be named as co-inventors on a resulting patent application? The simple answer is: whoever contributed to the conception of the claimed invention.

    ... more

Wall Street BioBeat

  • Gains Steadily Building in Biotech Sector
  • G.Steven Burrill
  • For the second consecutive quarter we have seen positive gains for biotech, fueling the notion that the worst of the economic woes that have assailed the sector may finally be over. While biotech’s year-to-date performance still lags behind the general markets, there have been some encouraging signs that investors are coming back. These include the tremendous stock gains of Human Genome Sciences (share value up 555% in the quarter) and Targacept (share value up 783% in the quarter), driven by positive clinical data from their lead drug product candidates.

    ... more

Corporate Profile

BioMarket Trends

  • Sparing Patients the Needle Remains a Priority
  • Bruce Carlson
  • Three-quarters of biologic drugs cannot be delivered orally, and this has forced makers of most novel drugs to think about delivery. If a protein or peptide must be injected, makers then are seeking the most patient-friendly methods, including needle-free systems. This trend has helped fuel a $2.7 billon market for pharmaceutical products combined with needle-free technology.

    ... more

Sidebar


DRUG DISCOVERY

Feature Article

  • Search Intensifies for Diabetes Drugs
  • Nina Flanagan
  • The competition to develop new therapeutics targeting metabolic disease is heating up. Here’s why: the latest estimates from the American Diabetes Association state that there are nearly 24 million Americans with diabetes. In addition, approximately 32% of American adults are medically obese.

    ... more

Tutorial

  • Dual Scan Multiple Reaction Monitoring MS
  • Joanne Mather
    Paul D. Rainville
    Robert S. Plumb, Ph.D.
  • The inherent sensitivity and specificity of LC/MS/MS has made it the technique of choice for bioanalysis. However, as compounds become more potent and are dosed at lower levels, the resultant circulatory levels also fall. This requires accurate and precise methods capable of analyzing analyte concentrations in the pg/mL range in plasma.

    ... more

Assay Tutorial

  • Cellular-Signaling Pathway Signatures
  • Wendy Weatherford
    Alexander Karasyov, Ph.D.
    James Schwaber, Ph.D.
    Frauke Rininsland, Ph.D.
  • There is growing enthusiasm in the pharmaceutical industry for whole-system functional assays that reveal the action of potential drugs on integrated systems such as intact cells in order to find allosteric effects and off-target effects.

    ... more

OMICS

Feature Article

  • Sample Prep Advances Extend Mass Spec
  • K. John Morrow Jr., Ph.D.
  • Sample preparation for mass spectrometry has been the topic of several recent symposia extensively covered in the pages of GEN. Mass spectrometry has grown over the years into an essential tool for macromolecular characterization due to the development of more economical and user-friendly instrumentation as well as more effective and accurate sample processing.

    ... more

Tutorial

  • Using ClonePix FL to Assess Monoclonality
  • Julian F. Burke, Ph.D.
    Christopher J. Mann, Ph.D.
    Sky Jiang
    Kerensa J. Klottrup, Ph.D.
    Natalie Smithers, Ph.D.
    Omee Ahmed
  • Isolation of candidate mammalian cell clones by limiting dilution, ring cloning, or simple manual collection of colonies is a time-consuming, resource-intensive, and costly procedure that is prone to cross contamination of cells and user error. One major disadvantage commonly encountered is the difficulty in establishing monoclonality—an essential step in the production of therapeutic proteins and antibodies.

    ... more

BIOPROCESSING

Feature Article

  • Single-Use Systems Make Headway with Skeptics
  • Angelo DePalma, Ph.D.
  • In recent years, GEN has reported on single-use bioprocess bags, connectors, sensors, and tubing many times. The benefits of disposables are, by now, well known and do not require repeating. An early knock on disposables was their limited volume, but the debut of 2,000 L bioprocess containers, accompanied by dramatic improvements in protein titers from cell cultures, dramatically expanded the scope of disposables. Yet, Sartorius Stedim Biotech estimates that single-use equipment has penetrated less than 20% of its potential biomanufacturing market.

    ... more

Tutorial

  • Shaken Bioreactors Provide Culture Alternative
  • Tibor Anderlei, Ph.D.
    Christoph Cesana
    Cedric Bürki
    Maria De Jesus, Ph.D.
    Markus Kühner
    Florian Wurm
    Rene Lohser
  • The application of shaken bioreactors for cell cultivation has increased enormously in the last eight years. These bioreactors are used for the expression (transient and stable) of recombinant proteins in drug and diagnostic research. Extensive tests demonstrate their potential in terms of performance, flexibility, and cost-effectiveness when compared with more conventional technologies.

    ... more

CLINICAL RESEARCH & DIAGNOSTICS

Feature Article

  • Animal Imaging Transforms Development
  • Elizabeth Lipp
  • Rapidly evolving imaging technologies were front and center at the “World Molecular Imaging Congress”, which was held recently in Montreal. This year’s meeting provided a timely forum to discuss the use of imaging in drug development, an application that is experiencing vigorous growth.

    ... more
  • New Capabilities Fortify Biodefense Tools
  • Gail Dutton
  • Clinical detection methods are taking to the field, boosting the capabilities of point-of-care biodetection devices for clinical use as well as battlefield diagnoses. Speakers at Select Biosciences’ “Advances in Biodetection Technology” held in London last month outlined their work in developing fluorescent imaging for explosive particulates and several approaches to integrated PCR amplification and detection for point-of-care applications and environmental field work. Rapidity was a hallmark of most of the advances.

    ... more
  • Third Option for Stem Cell Research Emerges
  • Kenneth C. Aldrich
  • Remember this term: Parthenogenesis. This six-syllable word could be the answer to controversy-free stem cell research. Though the general public is well aware of the medical potential and controversies surrounding embryonic stem cells and iPS cells (induced pluripotent stem cells), a third way forward—parthenogenesis—has been surprisingly sidelined from the stem cell research debate.

    ... more

Tutorial

  • Applying Real-Time PCR to Strain Identification
  • Arun Apte
  • Efficient clinical diagnosis of pathogens is important for the management of infectious diseases. Conventional methods have longer turnaround time and, in most cases, lower sensitivity. Nucleic acid based methods for detection of microorganisms are rapid, sensitive, and are generally successful even when the culturing of microorganisms fails. Sequence-based molecular methods such as real-time PCR provide rapid diagnostics and higher sensitivity, allowing differentiation between related strains. 

    ... more

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