Development

The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.

Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.

The US Food and Drugs Administration is boosting its efforts for orphan drugs development.

Resolve confusion about measurements.

Best methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process.

A discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells.

With a variety of recombinant, animal-free, defined protein supplements such as growth factors, transferrin, and albumin entering the market, the biopharmaceutical industry now has innovative and safer alternatives to serum and other animal-derived supplements.

Gene fusion tags can improve the yield and solubility of many recombinant proteins. This article discusses the most popular fusion tags and the proteases used to remove them, with special reference to recently introduced technologies.

Using chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.

Recombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide.

Process-modeling tools can ensure smooth tech transfer.

The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.

US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency.

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

A comparison of primary harvest techniques.

Disposable technologies that mimic the conventional stainless-steel bioreactor will be most readily adopted

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

Manufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology.

An alternative approach to traditional Protein A schemes is comparable in overall efficiency, product recovery, and quality.

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

If certain engineering challenges can be addressed, precipitation may prove to be a valuable tool for antibody purification.

When platform processes are applied to fusion molecules, innovation and flexibility are needed.

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.

On February 21, 2008, a congressional committee sent letters to Baxter Healthcare and the FDA seeking information related to the recent heparin recall.

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

The use of disposables has changed significantly in the biopharmaceutical industry.

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.