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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 - Mar 1, 2010 (Vol. 30, No. 5 )


BIOBUSINESS

Feature Article

  • GEN’s RNAi Cryptogram Decoded
  • A researcher at a company that develops, manufactures, and distributes cell culture media and molecular biology reagents has solved the first version of “GEN’s Cryptogram Challenge: RNAi.” It took him only 10 hours to come up with the answer: Wily siRNA quenches gene.

    ... more
  • Ramping Up Technology Commercialization
  • Amy Spaisman
    Phyl Speser, J.D., Ph.D.
  • Commercializing biotechnology is challenging. Hurdles include, but are not limited to, securing funding, navigating the approval process, and managing technology risk. These key barriers must be overcome or circumvented to achieve successful market entry. This article will focus on two common challenges: raising money and securing stakeholder support.

    ... more

Point of View

  • Tempering Regulation with Common Sense
  • Henry I. Miller, M.D.
  • Frank Young, former head of the FDA, used to admonish his minions that there were times that common sense should trump established policies or rules. Other officials have not been so wise.

    ... more

Legal Affairs

  • ACLU Takes on Patent Office & Myriad Genetics
  • Scott Rylan Powell
    Gerry J. Elman
  • On February 2, Judge Robert M. Sweet at the U.S. District Court in Manhattan heard oral arguments in the case of Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.

    ... more

Wall Street BioBeat

  • Big Pharma Reassesses Orphan Drug Sector
  • Benjamin J. Conway
  • As evidenced by the recent licensing deal between Pfizer and Protalix Biotherapeutics for the Gaucher disease treatment taliglucerase alfa, there is significant interest among big pharma companies in orphan drug indications. Long considered niche markets and the domain of their smaller biotech brethren, traditional pharmaceutical companies are now re-evaluating their position on orphan drugs. A confluence of market dynamics and scientific advances seems to be driving this change.

    ... more

BioMarket Trends

  • Realistic Expectations Likely to Prevail in 2010
  • Eric S. Langer
  • The biotech industry is starting the new decade with good reason for cautious optimism. Based on results from our current 7th Annual Report and Survey of Biomanufacturing, most companies are more confident, but also more realistic: 2010 will bring good results, but managers are expecting better performance from the same staff. Some of last year’s budgetary shifts are becoming solid trends that are defining how biopharma will evolve over the next few years. Key developments in 2010 will include advances in science, technology, the economy, and regulations.

    ... more

DRUG DISCOVERY

Feature Article

  • qPCR Trends, Techniques, and Tools
  • Kathy Liszewski
  • The fast-paced, continually evolving field of quantitative PCR (qPCR) will be showcased at a CHI meeting in San Diego next month. Presenters will describe cutting-edge methodologies and emerging technologies such as digital microfluidics, nanopore and single-molecule sequencing, and improved ways to standardize data.

    ... more

Tutorial

  • Quantitative HT Gene-Expression Analysis
  • Sam Roberts
  • Pharmaceutical and biomedical research is evolving to take advantage of the development of bioinformatic research programs, incorporating data from new high-resolution assays and technologies such as microarrays and fluorescent in situ hybridization.

    ... more

Assay Tutorial

  • Tumor Cell Migration Assays in 3-D ECM
  • Victoria Echeverria
    Ivar Meyvantsson
    Steven Hayes
  • Metastasis is responsible for most cancer deaths, and tumor cell migration is an important part of the metastatic cascade. Understanding how tumor cells mobilize and invade other tissues, as well as how to modulate this behavior, is of great value to cancer biology and the development of therapeutics.

    ... more

OMICS

Feature Article

  • Development Strategies for Biomarker Assays
  • Catherine Shaffer
  • Biomarkers have become some of the most desired clinical and research tools in the life sciences. They have the potential to transform a drug discovery program and save lives in the clinic if they can be discovered, developed, and validated properly.

    ... more
  • Protein-Protein Interactions
  • James Netterwald, Ph.D.
  • If nature did not allow protein-protein interactions to occur inside living cells (and viruses), life as we know it would simply not exist. Molecular biologists have long struggled with developing methods to study protein-protein interactions.

    ... more
  • Targeted Resequencing Improves Precision
  • K. John Morrow Jr., Ph.D.
  • Next month in San Diego, CHI will present “Now Generation Sequencing” in which discussions about targeted resequencing will be front and center. This mixture of molecular biology and sophisticated computer analysis hones in on genomic regions of interest, interrogating multiple genetic sites. Enabling the detection of rare mutations and hard-to-reach corners of the genome, it takes advantage of low sample-input requirements. Moreover, these strategies allow areas of interest to be identified through genome-wide association studies while sequencing genes and candidate regions.

    ... more

BIOPROCESSING

Feature Article

  • PTMs Progress Toward Designer Proteins
  • Angelo DePalma, Ph.D.
  • Of the essential post-translational modifications (PTMs) that proteins undergo before their synthesis is complete, glycosylation is arguably the best known. The medical and economic significance of monoclonal antibodies and other glycoproteins has spurred a resurgence of interest in glycans, particularly in their analysis and ways to direct their biosynthesis in desirable ways.

    ... more

Tutorial

  • Use of Microvolume Analysis in Processing
  • Philippe Desjardins
    Manju Sethi
    Tim Brown
  • Simple solutions are increasingly being integrated in the ever-changing bioprocessing environment. As methodologies improve throughout the protein production industry, tools must have the flexibility to adapt quickly to new workflow demands. With process analytical technology (PAT) continuing to bring significant improvements, innovative technologies that can evolve with industry methodologies are essential for bioprocess optimization. The choice of equipment and instrumentation has a great impact on the protein process workflow and on de-bottlenecking steps.

    ... more

Tech Note

  • Characterizing Viral Titers in Manufacturing
  • Andrew Malloy
  • There are two main categories of viral vaccines—live (attenuated) and killed (inactivated) vaccines. A live attenuated vaccine is one where the virulence of the virus has been reduced, such that when the vaccine is administered to the patient it induces an immune response without causing clinical disease. The virus will replicate within the host and hence provide immunity for an extended period of time. The majority of successful viral vaccines fall under this category including vaccines for measles, mumps, rubella, influenza, yellow fever, and polio (Figure 1).

    ... more

CLINICAL RESEARCH & DIAGNOSTICS

Feature Article

  • Oversight of Research Use Only Products
  • Jeffrey N. Gibbs
  • The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) products are essentially unregulated. In fact, although RUO products are often discussed as though they are a kind of medical device, RUOs are not devices at all.

    ... more

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