Quality/GMPs

Several methods are available to assess RNA integrity and purity, which may affect downstream applications.

Operating costs are the white-hot issue in the boardrooms of our life sciences clients and they tend to rule the site selection process. A soft economy, worldwide trade competition, drug cost containment pressures from the US government, and a lean and mean message sent by the venture capital community mean that quantitative factors that focus on the cost of doing business are trumping qualitative lifestyle factors, especially when evaluating sites for a new biopharmaceutical facility.

Many industry professionals know that analytical testing for biopharmaceuticals for all raw materials, production in-process stages, and final containers must be validated, and they generally understand how this can be achieved. Many of us even understand the basic concepts of laboratory compliance and production process quality. However, how exactly are analytical test method performance and process robustness related and how do they depend on each other? Furthermore, how do we monitor and maintain the accuracy and reliability of analytical methods long after validation completion to ensure the suitability of these methods for measuring process quality?

...each day a product is delayed is estimated to cost upwards of $1 million to $100 million.

Departure from dilutional similarity can be interpreted as evidence that the groups of organisms are not comparable or the preparations do not contain the same active compounds.

IT, payroll, manufacturing, and clinical-trial data management are key areas for growth in biopharm outsourcing efforts.

Health programs seek to establish secure systems to manage the fast-expanding quantities of drugs and medical products going to developing countries.

The Senate confirmed Lester Crawford in July as the official head of the Food and Drug Administration (FDA). Crawford's nomination had been put on hold as various legislators pressured FDA to approve an over-the-counter version of the "morning-after" pill, Plan B, and to support broader drug importing.

Formal process and operation improvement activities are being employed in almost every biopharmaceutical manufacturing company, according to a recent survey conducted by Tefen Ltd and Millipore Corporation. The industry-wide survey was conducted to assess current biopharmaceutical operations excellence (OpEx) trends and needs, as well as OpEx perceptions and expectations related to industry suppliers.

...biopharmaceutical companies still face rampant piracy and counterfeiting of patented products.

Daunting but common challenges currently face many biotech, pharmaceutical, and device firms. These companies are encountering a restless public, worried investors, and a skeptical, publicity-hungry Congress that are all concerned about product safety and the reliability of regulators' scrutiny.

Current best practices of containment reduce the risks associated with biotech development.

Pharma industry equipment utilization hovers below 40 percent, which would be an unacceptable figure in most industries.

Part of the problem with cancer drugs as investment picks is that investors don't trust the underlying studies that seem to prop up vaccine maker stocks.

Historically, the big pharmaceutical companies (Big Pharma) have sought to feed their marketing machines by manufacturing blockbuster drugs—chemical-based, one-type-fits-all products that treat chronic conditions such as heart disease or arthritis. This approach has yielded recurring revenue streams from large patient populations. In contrast, biotechnology companies typically have created protein-based drugs,or biologics, to treat acute or niche conditions and diseases. With few exceptions (such as the biotech giant Amgen), biotech companies have foregone doing the marketing and sales of their drugs themselves, and have, instead, relied on others to perform their marketing and sales functions.

The Interface of America's Antitrust and Intellectual Property Laws

Patents are litigated in the biopharmaceutical industry perhaps more often than any other form of IP

Trademark protection in the US is based on a dual system of federal and state laws.

Biopharmaceutical companies need to consider intellectual property issues early on, even at the start-up stage.

Your research and development team has just shouted "Eureka!" after long and expensive years of research, exclaiming they have developed a next-generation pain reliever. What do you do next? This article explores and suggests your next steps and identifies pertinent questions to ask a patent attorney. The focus is on intellectual property; this article does not address the myriad regulatory issues that must be resolved.

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

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.

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.

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

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