Development

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.

Design space concepts are key to a successful technology transfer.

The personalized medicine bandwagon is on a roll, offering a new model for calculating reimbursement of high-cost biotech therapies. Strategies for identifying patients who will respond to a certain therapy, as well as those most likely to suffer adverse events, promise to improve healthcare quality while eliminating waste and inappropriate spending. Interventions based on individual genetic characteristics may have limited sales, but support higher prices and less costly clinical research methods.

A solution for the problems of a "bag in a can" system would be a fully jacketed and insulated container, similar to a traditional freeze tank.

Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development

Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.

It is commonly believed that technologies in the next 10–15 years will enable sequencing an individualized human genome for less than $1,000. With innovations like these, the twenty-first century will certainly belong to biotechnology. From an industrial standpoint, the discovery of therapeutic molecules and the development of cell lines and processes to produce these molecules will be of paramount importance. This article describes various approaches that have been prevalent in the industry or are likely to be used in the future for generating cell lines with desirable traits and developing high titer cell culture processes.

It became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.

Small biotechnology companies often need guidance during the development of new therapies-particularly when it comes to manufacturing.

In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.

The new legislation authorizes the use of fee revenues for drug safety oversight and assessment throughout a product's lifecycle.

From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.

Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination.

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.

Now equipment makers are designing new systems that can be deployed rapidly, are less costly to build, and require less water and power to operate.

FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.

Viragen, Inc. (Plantation, FL, www.viragen.com), and its collaborative partners in the field of avian transgenics-Roslin Institute (Scotland, UK, www.roslin.ac.uk) and (Oxford, UK, www.oxfordbiomedica.co.uk)-have announced a significant breakthrough in the development of the OVA system, an avian transgenic protein expression technology.

Growth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.

In addition to existing guidance, in January 2007 the FDA announced further proposals to prohibit the use of certain bovine materials as ingredients in some medical products or as elements of product manufacturing.