Quality/GMPs

The Food and Drug Administration's Prescription Drug User Fee program (PDUFA) has to be reauthorized by Oct. 1, 2007, and all the interested parties are fine-tuning their wish lists for "improvements." Although some consumer advocates and their Congres-sional allies blast user fees for extending industry control over the drug approval process, FDA officials, pharma companies, and patient disease groups applaud the program's success in ending "drug lag" and speeding new drugs and biotech therapies to market.

Before designing cleaning procedures, it's vital to know all physical and chemical characteristics of the product ingredients.

Human infections with avian flu strain H5N1 are occurring in a number of southeast Asian countries that have experienced large outbreaks of avian influenza. How great a risk to the human population is posed by this virus, and what steps can be taken to minimize its impact? Preventive vaccines have great potential to avert the spread of avian flu and other infectious diseases. What are the factors affecting the creation of new vaccines, and how can they be optimized to promote public health?

Ultra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.

Cleaning validation is a critical consideration in the pharmaceutical industry. Inadequate cleaning can result in contamination of drug products with bacteria, endotoxins, active pharmaceuticals from previous batch runs, and cleaning solution residues. Such contaminants must be reduced to safe levels, both for regulatory approval and to ensure patient safety.

How much of an impact does patent reform, real or imagined, have on biopharmaceutical stocks?

Andrew von Eschenbach, acting commissioner of the Food and Drug Administration (FDA), says that implementing the Critical Path Initiative is "one of my highest priorities," and is encouraging more FDA collaboration with other government agencies, academia, and industrial partners to find better ways to encourage innovation. As head of the National Cancer Institute (NCI), Von Eschenbach has supported joint projects with FDA to spur development of new cancer drugs, including efforts to qualify biomarkers for cancer detection in specific patient populations and to examine how imaging technologies can monitor the impact of therapies on cancer tumors.

PAT can be defined as a collection of real-time data in-line to make decisions about product quality early in the production process.

The cell density achieved in a CELLine bioreactor is typically 1 to 2 orders of magnitude higher than in a conventional culture vessel

A 2000 cyber crime study revealed that 71 percent of security breaches were caused by people who worked within the company.

All potential uses and supporting endeavors of the data must be examined and then defined as a virtual process stream.

Doctors can charge up to $500 per hour to discuss the pros and cons of clinical drug trials.

This quality approach to biotech manufacturing may also establish a pathway for approving generic versions of biotech therapies.

You tell me whar a man gits his corn pone, en I'll tell you what his 'pinions is."

Achieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive. In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these guidelines more evident.

"Smart" tags speak only when spoken to. "Brilliant" tags are capable of independent decision-making.

Facts@FDA...ultimately will contain current product labeling information plus safety data gleaned from adverse event reports.

According to a 2005 study by the American Academy of Neurology, donepezil may improve the memory of Alzheimers patients and those suffering with multiple sclerosis.

Validation of a cleaning process demonstrates that it can reliably and effectively remove residue to an acceptable level.

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.