BioPharm International-08-01-2005

August 01, 2005

Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.

August 01, 2005

Presenting documentation in a timely manner will expedite the inspection process and provide a positive impression to agency representatives.

August 01, 2005

It's summer and the living is easy if you don't mind heat, insects, and thunderstorms. The biopharm indexes are listless, because August and September are notorious for inactivity in the various life sciences stock market indexes. Earnings announcements taper off and life sciences companies keep their gunpowder dry by holding off new announcements until after Labor Day. As of mid-July, the American Biotech Index (Symbol: BTK) has leveled off at the tail end of a year of unbridled growth. If history is any indication, the autumn months will see another rise from the 550 or so levels we're now seeing in the BTK.

August 01, 2005

The pharmaceutical and biotechnology industries are at a critical point in their evolution. Industry experts at Datamonitor, an independent market analyst firm, say that in 2002 about $30 billion worth of blockbuster drugs lost patent protection. By 2008, an additional $35.5 billion worth of products is expected come off patent. At the same time, a host of scientific innovations in drug discovery including the use of high-throughput screening techniques, new classes of therapeutics such as aptamer technology and RNAi, and genomics-driven discovery methods, have resulted in large numbers of new drug candidates.

August 01, 2005

The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.

August 01, 2005

Scotland has a ready pool of skilled workers for companies seeking to conduct business in our country.

August 01, 2005

Subcutaneous administration is likely to be an important factor in generating an immunogenic response.

August 01, 2005

A more recent challenge for CBER is to ensure the safety of an expanding number of tissue and cellular products used in transplants.

August 01, 2005

Shortly after London's ordeals, I heard of a new piece of intelligence suggesting that a large pharmaceutical company is on a short list of possible Al Kaeida targets. Since I'm sure all pharmaceutical facilities are securely buttoned up, I wonder more about our industry as a whole becoming a focus of attack by these maniacal extremists.

August 01, 2005

Successful acquisition of funding from venture capital (VC) partnerships requires a carefully planned, well-executed marketing campaign. You are, after all, selling ownership interests in your company when you seek VC investors. This sale requires an attractive product, nicely packaged, and presented in a way that allows the potential customer to understand and appreciate its value. The attractiveness of your company is the sum of many factors including revenue potential, intellectual property estate, time-to-milestones, existing competition, ease of entry, quality of management, and the perceived interest in your work by "the big guys" in your sector. Every potential venture investor will not perceive your company the same way.

August 01, 2005

Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.