August 1, 2008 (Vol. 28, No. 14)

During a discussion on biofuels in China, Carsten Lauridsen, director of R&D, Novozymes China, pointed out that Novozymes has been working with China National Cereals, Oils & Foodstuff to develop biomass-based biofuels in that country. Strengthening national energy security, improving the welfare of farmers, and reducing air pollution are the three main drivers underpinning the strong push for the development of alternative energy sources, including the production of ethanol from cellulosic substrates, according to Thomas Videbaek, evp for Novozymes.

Official fuel ethanol production began in 2004. Actual production reached 640 thousand metric tons in 2005. Expected 2007 production is 1.5 million metric tons, making China the third largest fuel ethanol producer after the U.S. and Brazil, continued Videbaek. Corn-based fuel ethanol accounted for 2% of total gasoline in 2006. China aims to more than double its fuel ethanol production by 2010.

Ethanol will grow from the current 2% to 5% of total transport fuel in 2010. The additional capacity will come from the usage of alternative starchy feedstock of cassava, sweet potato, and sweet sorghum and also cellulosic feedstock such as corn stover, rice, or wheat straw. Commercialization of cellulosic ethanol is expected within three years from now, added Videbaek.

> The first products to be marketed via a strategic alliance between Millipore and Novozymes will be launched at the beginning of the fourth quarter. CellPrime™ Recombinant Human Transferrin and CellPrime Recombinant Human Albumin (Saccaromyces) are animal-origin free and can be used in defined media, noted Andrew Bulpin, Ph.D., vp, upstream processing, Millipore.

> Martin Madaus, chairman and CEO of Millipore, awarded Jeanne Loring, Ph.D., of The Scripps Research Institute, a $150,000 grant to investigate the potential of human pluripotent stem cells for treating Alzheimer’s and Parkinson’s diseases. Dr. Loring thanked Madaus for providing “pickaxes for the new gold rush,” while he recognized her epigenomics research.

> Heath Knight, Ph.D., executive director, genomic services, Third Wave Technologies, explained that the company’s recent acquisition by Hologic, a company focused on women’s health, for $580 million was largely due to Third Wave’s expertise in molecular diagnostics, including its Invader® chemistry technology and its HPV tests currently in development.

It’s estimated that there are 10 million HPV tests being performed in the U.S., representing a $200 million market with growth in excess of 40% in each of the past five years. A Hologic spokesperson thinks the global market for HPV testing will increase to $800 million in the next few years.

> Friedrich Nachtmann, Ph.D., head of biotech cooperations at Sandoz, described the company’s new Npro Autoprotease Fusion Technology (NAFT). Sandoz developed the tool for improved expression and isolation of fusion proteins. The system leads to controllable, quantitative, and autoproteolytic cleavage resulting in an authentic N-terminus, according to Dr. Nachtmann.

“Advantages of NAFT include high fermentation yields [>10 g/L] and cleavage/refolding yields greater than 75 percent,” said Dr. Nachtmann. “In addition, process enzymes and costly reagents are not required for cleavage.”

> Eden Biodesign Ltd. chose Research Triangle Park, NC, for its new U.S. subsidiary—Eden Biodesign, Inc. The facility will offer cell line/strain development and early process development services. Eden targeted the eastern seaboard and mid-Atlantic region from Massachusetts to North Carolina for reasons of communication with the company’s operations in the U.K., according to Roger Lias. Ph.D., president, Eden Biodesign, Inc.

“We ultimately selected the Research Triangle Park area because it is a key biopharmaceutical manufacturing hub that offers access to highly qualified employees and excellent class A wet lab space for lease at reasonable rates,” said Dr. Lias.

“The first-rate local universities, the support of the North Carolina Biotechnology Center, excellent training initiatives, and a cohesive local biotechnology community all contributed to making us very happy with our decision.”

> Chris Newton, Ph.D., senior vp of BioFocus DPI, the service division of Galapagos, gave a “BIO” Theater Presentation talk on his company’s new Intelligent Screening approach designed to accelerate drug discovery programs.

He described the three core technologies that constitute the screening paradigm, including PrimePath™ compound screening in disease-relevant complex assays in human primary cells, ion-channel screening in high-throughput/information-rich assays, and natural product screening to address difficult targets.

> Lytix Biopharm reported that it has gained enough data to advance Oncopore™, its first oncology product, to clinical trials next year. This therapy quickly disintegrates a wide range of tumor- as well as drug-resistant and drug-sensitive cancer phenotypes and also evokes an immune response, according to company scientists.

> Diagenic is preparing to launch a breast cancer assay in September in India that accurately detects stage 0 and 1 tumors using only a drop of blood. The company expects the product to be CE marked by the end of the year for marketing in Europe in 2009.

> Paul Kinnon, the California-based CEO of New Zealand company Zygem, commented on his company’s June signing of agreements with Zee Tags for DNA kits designed to facilitate the extraction of DNA from various types of samples used for the genetic testing of livestock and with Diagnotec for kits to detect the devastating infectious pancreatic necrosis virus affecting fish farms.

“Our DNA-extraction technology harnesses the power of an extremophile enzyme to extract DNA from a wide variety of sources in a single tube,” he explained.

“This technology is flexible and can be integrated into a wide variety of analytical platforms for the analysis of DNA and other nucleic acids. We currently market our prepGEM™, forensicGEM™ and livestockGEM™ kits for specific markets and scientists.”

> Currien MacDonald, M.D., medical director of ASPIRE IRB, believes that “the next generation of diabetes drugs will prevent and cure diabetes, rather than just prevent complications.” Among the drugs in clinical trials are an insulin sensitizer, a drug to reverse blood vessel damage, and several glucagon-like peptide analogs that control weight loss and blood sugar.

> Parexel International is adding pain modeling capabilities and combining traditional pharmacodynamic methods with relevant biomarkers in its CRO service offerings.

“Central nervous system diseases, which are reported to account for one-third of the world’s disease burden, include neurodegenerative diseases such as Alzheimer’s and conditions characterized by chronic pain,” said Michelle Middle, corporate vp of Parexel.

> Many scientists say cell-based assays are theoretically capable of generating multiple readouts from each test. Jo Oliver, Ph.D., CEO of Avanticell, noted that 3-D cell screens are expected to provide the best in vitro models. As a result, cell-based assays incorporating 3-D culture and/or multiplex options are being added to the AvantiCell product range this year, according to Dr. Oliver.

> Finn Willingham, Ph.D., head of project management at Angel Biotechnology, reported that the company signed a GMP-manufacturing deal with Novolytics. Angel will manufacture and supply GMP materials for use in a bacteriophage-based MRSA prophylactic treatment as part of a Phase I/II trial scheduled to commence in 2009. The GMP-production project will be carried out over a period of seven months at Angels’ facilities in Edinburgh, according to Dr. Willingham.

> Pascal Bolon, Ph.D., sales and marketing manager for Eurogentec, discussed the company’s launch of a new range of Mesa Blue qPCR kits for SYBR® Assay with inert Blue dye, which does not affect the qPCR reaction.

The new product was designed to significantly enhance the contrast between reagent and plastic, making verification of master mix dispensing “quick, easy and foolproof,” said Dr. Bolon, who added that the the combined use of MESA kits for SYBR assays and the recently introduced opaque white plastic plates “shows a dramatic improvement in the sensitivity of qPCR results.”

> Xceleron announced that microdose data for 25 clinical candidates proved more than 80% predictive of pharmacokinetics compared to pharmacological dose.

“Microdosing is gaining acceptance as it is a new and more precise method for evaluating a drug candidate’s profile earlier than traditional practices,” said Colin Garner, Ph.D., CEO of Xceleron.

“With 1 out of every 5,000 compounds making it from bench to bedside, the intrinsic value of microdosing is that it enables companies to select and advance only those compounds to clinical trials that demonstrate optimal drug profiles predictive of success.”

The EMEA/FDA definition of a microdose is one hundredth of the proposed pharmacological dose, never to exceed 100 µg, explained Dr. Garner. “At these doses, the studies are classified as research and do not require GMP manufacture of the drug, saving both time and cost,” he added.

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