April 2008

Anything But Chromatography?

In 2006 a new term was coined that is now all too familiar in the industry: downstream bottleneck. With observations of a slow cycle of downstream process improvements indicating potential solutions in the next five years, downstream processing is a very hot topic at conferences and in publications. Thus, the Recovery and Purification track will be highly focused on this pertinent and timely issue. Beyond discussing the bottleneck itself head-on in the opening sessions, the track will focus on alternatives…

Management Engagement Is Key to Successful Quality Systems

Many models are available for establishing a quality system in regulated industry, whether for pharmaceuticals, medical devices, or biologics. Each company establishes a set of standard operating procedures (SOPs) that enables it to manage operations and then implements a quality system around its product and process. But why do some quality systems work well, whereas others falter or fail miserably? Does the fault lie in procedures, implementation, or maybe training? Perhaps the answer can be found by examining the involvement…

In the Therapeutics Zone

Small molecules are still not providing cures for many diseases, and this is why biological therapies continue to be developed. They often offer greater convenience to patients, as well as longer lasting therapies,” says William Prather, MD, senior vice president of corporate development at the Israeli stem cell company, Pluristem. The therapeutics area at this year’s BIO International Convention will play host to many interesting technologies for producing and improving protein therapeutics, vaccines, and stem cells. Protein Therapies Remain Top…

“In the Zone” at the BIO International Convention

We invite you to the 2008 BIO International Convention, Tuesday–Friday, 17–20 June 2008. Biotechnology innovations are addressing the world’s challenges to heal, fuel, and feed growing and changing populations. Our event cochairs (Catherine Mackey, PhD, senior vice president of Pfizer in La Jolla, CA, and Greg Lucier, chairman and CEO of Invitrogen Corporation in Carlsbad, CA) have focused the 2008 event theme and program to highlight this important role of biotechnology: Innovate. Heal the World. Fuel the World. Feed the…

Tackling Formulation and Delivery

The final hurdle in getting a product to market is the formulation and fill–finish step in process development. By their nature, protein therapeutics are more fragile and require a great deal of work to achieve product stability in final formulations. A cell line can be highly productive and efficient in protein production, but if you can’t stabilize the resulting protein and deliver it to patients intact, that’s a costly and useless exercise. The Formulation and Drug Delivery track of the…

In the Laboratory Automation Zone

When you hear the phrase “laboratory analysis” on a TV commercial, maybe you imagine a technician in a white coat and safety goggles pouring a chemical from one test tube to another. Technicians still wear white coats and goggles, but today, in many labs, they’re not the ones pouring the chemicals. Instead, tiny trays carrying minuscule dabs of samples are whisked by robots from one analytical workstation to another. The workstations are equipped with ultraprecise instrument systems to prepare the…

Cutting Down Process Time and Costs

Because the biopharmaceutical industry operates as an industry rather than a nonprofit, the bottom line is an important consideration in every aspect of product design. From laboratory automation methods that speed discovery to streamlined manufacturing processes that incorporate the themes of operational excellence, Lean manufacturing, and quality by design, the industry is undeniably focused on minimizing cost and maximizing revenue. At the BioProcess International European Conference and Exhibition, the Scale-Up and Manufacturing track will focus on economic strategy and technology…

In the Industrial Zone

Figure 1. The same genomic and proteomic technologies used to discover new drugs and therapeutics are also changing the way we live and some of the products we buy. Technologies have yielded new enzyme biocatalysts, used in producing raw and intermediate materials and consumer products. In addition to improving crop and food production, companies are using the tools of biotechnology to manufacture materials from renewable and sustainable resources, build environmentally sound industrial processes, and develop innovative solutions to growing global…

Austria Welcomes BioProcessors

When it comes to agriculture, the people of Austria are among the most dead-set against so-called “genetically modified organisms” of any population in Europe (1). But as is so often the case elsewhere, their attitude toward biotechnology used in medicine is much more friendly. This may have to do with the country’s traditional strength in environmental biotech (ranging from wastewater treatment and organic waste composting to anaerobic digestion for biogas generation) and also food biotechnology. That is the suggestion of…

In the Facility Design Zone

As companies grow and expand their product offerings, it becomes necessary to consider manufacturing space. The decision to build is not made lightly, because CGMP manufacturing space comes at a steep price. Estimates range from $500 to $1,400 per ft2 to build new biopharmaceutical manufacturing space (1,2,3). As Jean-Francois Denault, Agnes Coquet, and Vincent Dodelet point out in their article in the February issue of BioProcess International, non-GMP biomanufacturing space comes at a much lower cost due to the lack…