Quality/GMPs

The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.

Engaging executive leadership in the quality process is the key to compliance success.

A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.

Did the 2005 Patents Act engender a Western intellectual property rights culture in the country?

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

Now is a good time for companies to know their suppliers well.

The supply base for preclinical and clinical development services continues to expand in China.

India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.

More informed submissions may lead to regulatory flexibility for postapproval changes.

A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.

Emerging therapies pose challenges for standardizing QC.

The expanding globalization of the industry poses a challenge for international enforcement.

Need a standard to follow? Just ask, What would Genentech do?

Following the partial recall initiated on January 25, 2008, Baxter Healthcare has expanded its recall of heparin.

It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.

Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps.

The development and optimization process can improve a method, but validation does not. Validation is the final proof that regulations and expectations are met.

Several steps can be taken to maintain test method suitability after the formal completion of the analytical method validation studies,

Two case studies illustrate a systematic approach.

The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.

Both innovator and generics companies are using analytics to support comparability arguments.

Best practices from Big Biotech, including how to handle new product introductions.

The key to a good graphical presentation is to select the method that best fits the data.

Indian biogenerics could form a major piece of the global biotherapeutics market in the future.

The new year begins on a note of optimism. A major breakthrough in stem cell research promises to open the door to new biomedical research opportunities. The drawn-out Congressional debate over user-fee reauthorization and drug safety regulation is over, and most parties seem satisfied with resulting compromises. The vaccine industry is experiencing a resurgence after years in the doldrums, with important new vaccines on the market and more under development. And unlike many previous years, the US Food and Drug Administration (FDA) had a confirmed commissioner for all of 2007 and relatively stable leadership.

In the process of developing breakthrough biopharmaceuticals with profound therapeutic promise, the many detailed requirements for a successful investigational new drug (IND) submission may seem petty, but they are not. With an IND, you are essentially moving from the cloistered world of the laboratory into a highly regulated industry where details not only matter, but are also greatly magnified by the overriding requirements of safety and efficacy. Treat those details with forethought and you will eventually succeed. Treat them as an afterthought and all of your pioneering science, state-of-the-art technology, and therapeutic ambition could come to nothing. At the very least, your progress to market could be delayed significantly. And if, like most young biopharmaceutical companies, you are on a short financial leash, such delays can be fatal for securing additional funding.

Design space concepts are key to a successful technology transfer.

How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.

Developing a process validation strategy early in clinical development is critical for a successful validation program.

Many companies acknowledged that Western regulatory standards are tougher than those in China.