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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 15, 2009 (Vol. 29, No. 20 )


BIOBUSINESS

Feature Article

  • Oklahoma Seeks to Retain Local Research
  • Gail Dutton
  • Three of the 17 drugs approved by the FDA in 2007 originated in Oklahoma. Surprised? The key word is “originated.” Projects have a strong tendency to originate in Oklahoma’s laboratories but be developed elsewhere.

    ... more

Corporate Profile

BioMarket Trends

  • Transfection Market Clamors for Silver Bullet
  • Jonathan Witonsky
  • Transfection of nucleic acids into cells is often cited as users’ rate-limiting step in numerous biomedical research and bioproduction workflows. Accordingly, the burgeoning markets that surround biopharmaceuticals, RNA interference screening, and stem cell research are limited by the lack of a silver bullet for successful gene transfer.

    ... more

Spotlight on the FDA

  • Cracking Down on Misinformation
  • Bruce F. Mackler, Ph.D., J.D.
  • FDA reads your press releases, and it reviews your promotional materials and websites. It doesn’t just give them a cursory glance either, it scrutinizes them. As a result, biotech/biopharma companies are advised to fight the urge to dwell on or embellish the positives, especially in press releases where negative news actually predominates. This clouding of the truth is viewed by FDA as misleading and violative. 

    ... more

DRUG DISCOVERY

Feature Article

  • Strategies for Companies Targeting GPCRs
  • James Netterwald, Ph.D.
  • In the organism, communication occurs at both the macro and the micro level. At the micro level—inside the cell—communication occurs between proteins relaying messages along signal-transduction pathways from both the internal and external to various compartments within the cell through the process of signal transduction. GPCRs are at the center of many signal-transduction pathways, and as a result, they are the subject of many basic biological research studies, as well as prime drug targets.

    ... more
  • Taking Multiplexing to the Next Level
  • K. John Morrow Jr., Ph.D.
  • Multiplexing technologies are essential for the rapid screening of large numbers of samples in proteomic and genomic profiling. Tool providers are increasingly offering new solutions that feature ramped-up speed and efficiency. Other advances include disposable labware with improved plates for microarray screening, nanoparticle-based diagnostic tests, label-free systems, and multiplexing assays that identify small molecule drug candidates.

    ... more

Tutorial

  • Dried Blood Spots for Toxicokinetic Studies
  • James C. Robbins, Ph.D.
    Lee Goodwin, Ph.D.
    Phillip Turpin, Ph.D.
  • Toxicokinetic (TK) studies play an important role in the preclinical phase of the drug discovery process, determining the relationship between the systemic exposure of a compound in an animal model and its toxicity. Parameters such as bioavailability and dose proportionality of the compound are analyzed, from which the toxicity may be predicted and on which the doses to be used in clinical trials can be decided.

    ... more

Tech Note

  • Developments in Focused Kinase Libraries
  • Richard Hill, Ph.D.
  • Chemical libraries have long been a mainstay in the search for new pharmaceutical compounds, and they have been created using many different paradigms. Vast diverse collections of unique compounds have been screened at high throughput to find appropriate effects on target proteins. Such large libraries continue to be used for drug discovery, but screening smaller, more focused libraries, can provide more efficient solutions with better overall hit rates.

    ... more

OMICS

Feature Article

  • Improving and Enhancing the Use of Quantitative PCR
  • Kathy Liszewski
  • Quantitative polymerase chain reaction (qPCR or real-time PCR) is the gold standard for precise monitoring of selected genes. Its keen ability to both detect and simultaneously quantify specific DNA sequences underlies its popular use in diagnostics and basic research. Additionally, coupling qPCR with reverse transcription (RT-qPCR) provides a powerful means to quantify mRNA in cells or tissues.

    ... more
  • Making the Most of Transfection Processes
  • Catherine Shaffer
  • Although transfection has often been used as a tool to insert nucleic acids into cells, scientists don’t have a clear picture of how it works. Transfection is still a black box inside of which the experiment either works or it doesn’t. New developments in transfection focus on understanding more about how the process works, and how to make the most of it.

    ... more

Assay Tutorial

  • Pooled Genome-Wide shRNA Screening
  • Heather Holemon, Ph.D.
    Victoria Rusakova
  • RNA interference is an effective mechanism for gene silencing whereby double-stranded RNA triggers the cleavage and subsequent degradation of homologous transcript sequences. In this evolutionarily conserved process, longer double-stranded RNA molecules are processed into shorter sequences (21–23 nucleotide small interfering RNAs, or siRNAs) that can bind to the multicomponent RNA-induced silencing complex (RISC).

    ... more

BIOPROCESSING

Feature Article

  • Head Start Boosts Value of Stability Testing
  • Vicki Glaser
  • Maximizing and validating the stability of a drug is critical throughout its life cycle, beginning in the development phase of an active pharmaceutical ingredient (API), continuing through the final formulation process, and following commercialization as part of post-marketing product analysis.

    ... more

Tutorial

  • Analytical Considerations in Formulation
  • Sian Estdale, Ph.D.
  • Formulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation’s far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success.

    ... more

Roundtable Discussion

  • Sidebar: Industry Experts Share Flow Cytometry Insights
  • GEN recently spoke to several scientists with expertise in the flow cytometry arena about emerging trends and additional potential applications for this versatile research tool. Clare Rogers, application scientist at Accuri Cytometers; Robert Balderas, vp, biological sciences at BD Biosciences; T. Vincent Shankey, Ph.D., principal staff advanced research scientist, advanced technology/cellular analysis business group at Beckman Coulter; Fred Koller, Ph.D., president and CEO of Cyntellect; and Jason Whalley, flow cytometry manager at Millipore share their knowledge and predictions for the future in this flow-cytometry roundtable.

    ... more

CLINICAL RESEARCH & DIAGNOSTICS

Feature Article

  • Flow Cytometry's Expanding Niche
  • Richard A. Stein, M.D., Ph.D.
  • Cell population heterogeneity consistently emerges as an interesting and biologically relevant feature of biological systems. Nevertheless, many experimental tools are informative only about entire populations. While this level of inquiry is fundamental to our understanding of many phenomena governing the living world, only a limited number of approaches are available to dissect the differential behavior of selected individual cells within a group.

    ... more

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