April 2008 Supplement

In the Information Technology Zone

Successfully driving your global business requires vigorous, secure information exchange within your facility, from site-to-site, and with your partners and contract service providers. Tools to capture data in real time support decision making and enable companies to manage volumes of historical data needed for regulatory submissions. Software is available for data mining, managing clinical trial networks, and assessing toxicology data (among many other things). Information technologies in the biotechnology industry facilitate development and delivery of new therapies and diagnostics, improvements…

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…

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…

In the Clinical Trials Zone

A new product takes a long and winding road from a laboratory to the patients it is designed to help. Many factors and organizations affect just how many months and dollars it will take to shepherd a new product from preclinical studies to market. Carefully documented, regulatory-compliant clinical trials are key to marketing approval. Clinical trials involve a choreographed network of regulatory agencies, sponsor companies, and clinical investigators. Myriad specialists in that network include those who produce and deliver an…

In the Bioprocess Zone

Since the turn of the century, industry analysts have touted the “coming of age” of the biotech industry — and they’re inevitably talking about biopharmaceuticals. In fact, biotech has become the innovation engine for the pharmaceutical industry as a whole. Advances in genomics, proteomics, and other biotech research are bringing about not only new drug molecules, but also whole new therapeutic classes such as gene and cell therapies. Biotherapeutics represent the fastest-growing segment of the pharmaceutical industry, with more than…

In the Drug Delivery Zone

A rule of thumb in drug development states that the larger a therapeutic molecule is, the more trouble it will be to make, ship/store, and administer to patients. Biotherapeutics include proteins (such as antibodies), vaccines, some smaller peptides (such as hormones), DNA for gene-transfer therapies, cells and tissues, and to a lesser extent blood-fractionation products, allergenics, and RNA/oligonucleotides. Biomolecules are big and unwieldy, they’re produced in complex mixtures by biological processes, and they face numerous challenges in storage and within…

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…

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…