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 World.
Thank you to the
BioProcess International
editors, who created this supplement to provide us insight into the trends, insights, and relationships between topics in the 2008 BIO International Convention breakout sessions and product focus zones within the BIO Exhibition. We hope you will use “myBIO” online tool to sort through the event content and customize your schedule to meet your business needs. Hundreds of new companies are taking part in the BIO Exhibition. You can easily ...
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 investigational product, medical directors, project managers, statisticians, clinical research monitors, institutional and independent review boards (IRBs, also known as ethics committees), recruitment specialists, data managers, contract managers, medical writers, clinical investigators, clinical research coordinators, auditors, regulatory agency inspectors — and the list goes on.
Many of those clinical research professionals are employed by sponsor companies. Increasingly, however...
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 200 marketed products and hundreds more in development.
The maturation of this industry has created in its leaders an urgent desire to find solutions to manufacturing problems. Some perennially successful biotech companies such as Amgen and Genentech are joining the ranks of “Big Pharma” themselves, and “Little Biotech” isn’t so little anymore. And a grown-up industry has grown-up concerns. Any discussion these days of biomanufacturing systems inevitably falls under the growi...
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 the environment of a human body. Cells and tissues present an entirely different set of problems, from culture of autologous cells to immune-system problems with allografts.
The emergence of regenerative medicine and a move toward a global marketplace are creating a demand for new technologies that allow worldwide shipment of biological products while maintaining their viability or function. Effective biological packaging requires new understanding ...
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 ft
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to build new biopharmaceutical manufacturing space (
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,
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,
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). 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 of strict regulatory compliance required (
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). A “virtual biotech” company uses this fact to its advantage, contracting out the manufacturing and housing only scientists in an office environment with the leanest approach to this theme. That business model certainly has its advantages in the uncertain world of biopharmaceuticals, where everything rests on costly and lengthy clinical trials.
However, companies from small to large with successful products are facing the choice of whe...
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 energy needs.
“The renewable fuels and fuel efficiency standards that are now law have created a huge opening for advanced biofuels in the US transportation fuel markets,” said Brent Erickson, executive vice president for the Biotechnology Industry Organization’s (BIO’s) Industrial and Environmental Section, at a recent press conference.
“Make no mistake about it,” he stated. “This will be an ongoing project larger than both the Manhattan Project and the Apoll...
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 patient care, and other life-science and healthcare technologies, goods, and services (see “A Sampling of IT” products box).
Those who were working in the biotech industry in 1997 when 21 CFR Part 11 was introduced — detailing the FDA’s then-new requirements for incorporating electronic records and signatures — will remember how daunting those processes appeared to be (and how expensive) (
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,
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,
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). Enforc...
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 plates, apply dyes, dispense reagents, mix whatever needs mixing, incubate cells, maintain temperature controls, apply UV light or chromatography or spectroscopy or X-rays, and measure and record reactions — thousands of them in an hour. The whole operation is governed by a PC on the laboratory bench, which tells the workstations and robots how to conduct the testing and tracks the experiment’s progress from start to finish.
Laboratory automation offers scientists “the ability to set up large sequences of experi...
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 Dog
With an estimated market value in excess of US$57 billion in 2006 and a growth rate of 12% until 2010 (
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), it’s not hard to see why companies are still very active in protein therapeutics. One driver of this market (encompassing monoclonal antibodies, proteins and peptides) is the increasing need to produce safer protein therapies. Jeff Cleland, vice president of therapeutic development at Barofold and a speaker at the BIO convention this year, states: “The...