Biologic Drugs

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.

A comprehensive book about mass transfer benefits from the author's personal touch.

Cooling water is a critical component in the research and development, bulk manufacturing, and packaging of pharmaceuticals.

A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.

Biopharmaceutical companies generally try to avoid paying royalties on novel technologies, including novel expression systems, in part because of the inability to predict revenue flow after a product is commercialized.

The emergence of influenza A (H1N1) and the efforts to provide vaccines to the vulnerable are timely examples of biopharmaceuticals' continuing importance.

There may well be a pending revolution in biopharmaceutical expression systems. Nearly 50% of biomanufacturers today are demanding a whole lot more from their primary expression systems than they have during the past 30 years.

The importance of liposomes as an effective drug delivery system is well accepted in the pharmaceutical industry, but their handling remains a challenge.

The identification of an increasing number of drug targets coupled with advances in manufacturing technology could lead to many more blockbuster therapeutic antibodies.

The number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

Michiel Ultee talks about the challenges involved in transferring technology to a CMO and why communication is so important.

The productivity of the pharma industry has been declining for several years. Could biotechnology reinvigorate drug development?

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

A discussion of the basic principles of immunity and the nature of antibodies.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

The biotechnology sector is occasionally described as a rainbow, with each sub sector having its own colour. But what do the different colours of biotechnology have to offer the pharmaceutical industry?

A new year, all things being equal, is a time of looking to the future with positive intent and traditional bonhomie. At the very least, it suggests new beginnings. As we enter 2009, however, the world is moving into a major recession and things are far from equal.

Reducing ecological footprint and achieving more sustainable production of pharmaceuticals could help create a better future.

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

Hundreds of pharma–biotech deals have been announced during 2008 and many of these probably began at biopartnering conferences. Susan Aldridge examines some of this year's big buyouts and mergers.

Although realized in 1983, ASTM's standrad test method for determining bacterial retention of membrane filters used for liquid filtration is still hugely beneficial to today's pharmaceutical industry.

A well-balanced guide to industrial bioseparations provides valuable information.

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.

Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.

The author examines re-use of hydrophilic- or hydrophobic-membrane sterilizing-grade filters in liquid sterilizing applications.

More than 235 biotechnology companies call New Jersey home. They range from early start-ups with just a few employees to fully functioning companies with research, marketing and sales offices.

Although California remains the country's biotech leader, Michigan anticipates that the wind is shifting direction, albeit slowly

There are many challenges upstream and downstream in manufacturing a biotech drug.