Articles
The Lead
Automating Biomolecular Research Processes with LEAP Instrument
May 14, 2013 | by Fredrik Kamme, PhD, Vice President, Cell Engineering Unit; Marie L. Rossi, PhD, Manager, Technical Communications, Intrexon Corp., Blacksburg, Va. | Comments
Developing and maintaining cell lines for therapeutic bioproduction and biomedical research requires efficiency and accuracy. By automating the processes and techniques used in biomolecular research, scientists can achieve standardization, which can improve the speed, quality, and cost of drug discovery.
A Potential Treatment for Hypoactive Sexual Desire Disorder
May 23, 2013 11:44 am | by Robert E. Pyke, MD, PhD, Chief Medical Officer; S1 Biopharma, Inc., Jersey City, NJ | Comments
Hypoactive sexual desire disorder affects 10% of women in the United States and significantly...
Site-Directed Mutagenesis via Gibson Assembly
May 21, 2013 12:11 pm | by Ezra Schildkraut, PhD; Peichung Hsieh, PhD, Applications and Product Development Scientists; New England Biolabs, Ipswitch, Mass. | Comments
Gibson Assembly is a rapid and reliable method for the assembly of DNA fragments in a single-...
Important Considerations for the Manufacture of Biological Medicines
February 20, 2013 12:06 pm | by John Petricciani, MD, President; International Alliance for Biological Standardization; Geneva, Switzerland | Comments
While physicians stay informed about the medications they prescribe to ensure that patients...
The Promise of Companion Diagnostics
May 16, 2013 4:04 pm | by Christopher P. Leamon, Vice President of Research; Endocyte Inc., West Lafayette, Ind. | CommentsAdvances in biotechnology, together with an improved understanding of the underlying biology of disease, have led to the pursuit of more effective targeted therapeutics and the subsequent development of companion diagnostics to identify appropriate patients.
A Target Rich Environment
May 9, 2013 11:45 am | by Cynthia Fox, Science Editor | CommentsRecent meetings have provided a showcase for many potential druggable tumor targets. The range of potential new drug targets has been expansive, especially if one counts the whole-exome sequencing work being performed for the Cancer Genome Atlas project.
Producing Orally Bioavailable Biologics
May 8, 2013 3:24 pm | by Nick Terrett, Chief Scientic Officer; Ensemble Therapeutics Corp, Cambridge, Mass. | CommentsDrug developers have been in a quandary for some years now. The Human Genome Project offered novel insights into disease, including numerous tantalizing targets for therapeutic intervention. Unfortunately, many of these are protein-protein interactions not readily addressed by conventional “Rule of 5” small-molecule drugs.
Companion Diagnostics Keep Drug Development on Schedule
May 1, 2013 4:04 pm | by Sarah Ray, Research Analyst; Cutting Edge Information, Durham, N.C. | CommentsCompanion diagnostic tools allow companies to increase their chances of drug approval by targeting the right patients early. Developing the strategy, timing, and resources necessary for companion diagnostics success begins with understanding the mechanisms that successful companies use to build their programs.
Electroporation Key to Skin Cancer Treatment
April 30, 2013 10:56 am | by Punit Dhillon, President and CEO; OncoSec Medical Inc., San Diego, Calif. | CommentsDespite advances that have been made in sunscreen technology and growing public awareness of the need for sunscreen, recent data have found that the average U.S. lifetime risk of invasive melanoma has increased from 1 in 600 in 1960 to 1 in 50 in 2008.
Broader Bioreactor Applications
April 12, 2013 4:31 pm | by Mike May, Contributing Editor | CommentsThe appeal of cell culture–based production of drugs has increased demand for single-use bioreactors that can move into the process-development lab and help manage peaks and tight development schedules. Single-use bioreactors can be used for monoclonal antibodies, recombinant proteins, stem cells, and vaccines.
Questioning the Value of REMS
April 12, 2013 3:59 pm | by Ted Agres, Contributing Editor | CommentsThe U.S. Food and Drug Administration cannot determine whether its four-year-old Risk Evaluation and Mitigation Strategies program is working because drug companies have not provided key information when requested and the agency has not taken enforcement action against them.
Quantifying Apoptosis Via High-throughput Screening
April 12, 2013 3:49 pm | by David Guffey, MS, Senior Technical Service Consultant; Roche Diagnostics, Indianapolis | CommentsApoptosis, or programmed cell death, plays an essential role in organismal development and tissue homeostasis. During development, apoptosis is critical for the sculpting of organs and the elimination of unnecessary structures. Many cells die an altruistic death daily to secure homeostasis of the whole organism.
A Heat Shock Protein 90 Inhibitor for Advanced Refractory Solid Tumors
April 12, 2013 10:09 am | by John Lyons, PhD, Vice President, Translational Research and Development; Gavin Choy, PharmD, Vice President, Clinical Sciences and Operations; Amarpal Sahai, Senior Medical Writer; Mohammad Azab, MD, Chief Medical Officer; Astex Pharmaceuticals | CommentsA key function of heat shock proteins (HSPs) is to act as molecular chaperones to assist in the folding and stabilization of numerous client proteins. One family of HSPs—heat shock protein 90—stabilizes a diverse range of client proteins, many of which are involved in key pathways in malignancy.
Coming Up Short
April 12, 2013 9:54 am | by Peter Bennett, Editor | CommentsThe neverending din of partisan squabbling coming out of Washington can be deafening at times. Luckily for everyone, legislation like The Food and Drug Administration Safety and Innovation Act of 2012 seemed more or less immune to this cacophony, passing the Senate with 92 yay votes.
Tackling the Challenges of Compound Management
April 11, 2013 4:50 pm | by David Booth, Regional Sales Manager (Europe); Titian Software Ltd., London | CommentsThe day-to-day pressures on a compound manager come from several directions. There is pressure to support the increasing demands for samples in more diverse delivery formats; pressure to keep operational and supply costs down; and there has been the unfortunate trend toward staff reductions.
Dermal Delivery of Large-molecule Drugs
April 11, 2013 4:31 pm | by Bob Bruno, Principal; R.P. Bruno and Associates | CommentsScientists recently demonstrated that biphasic vesicles can deliver large-molecule or macromolecule drugs into the skin. Success with biphasic vesicles offers the potential for needle-free administration of many pharmaceuticals that could previously only be administered by injection.
Assessing Cardiac Toxicity Using Stem Cell-derived Cardiomyocytes
April 11, 2013 4:02 pm | by Oksana Sirenko, Research Scientist; Carole Crittenden, Application Scientist; Evan F. Cromwell, Director of Assay Development; Molecular Devices LLC, Sunnyvale, Calif. | CommentsPredicting the side effects of drugs remains one of the industry’s greatest challenges, with a large percentage of new drugs failing in clinical studies due to cardiac toxicity. The overall success rate from Phase 1 studies is only 11%, with 30% of these failing for safety reasons.
Controlling Your Image
April 11, 2013 3:29 pm | by Mike May, Contributing Editor | CommentsDrug discovery and development depends increasingly on imaging, from traditional microscopy to high-content screening. Moreover, these techniques provide sophisticated capabilities. To make the most use of these tools, researchers need advanced software that provides automation, analysis, and ease-of-use.
Engineering a Cure
March 7, 2013 12:05 pm | by Cynthia Fox, Science Editor | CommentsWhile the latest antiviral treatments can drop HIV levels to near undetectable levels, these drugs are a life sentence. Stop taking them and the virus comes raging back. New techniques are offering patients something previously thought impossible: a drug-free cure.
