The most important developments in biotechnology, as covered in Genetic Engineering & Biotechnology News, are available in print and on the web. Current GEN content, including feature stories, tutorials, news columns and financial, legal, opinion, and biomarket trends articles can be accessed at the GEN website.

Take a look at the stories that made it on to page 1 of GEN’s February 15 issue.

On Page 1: Coupling SPR Increases Value

Surface plasmon resonance (SPR) is not the new kid on the block. What is new is coupling this premier technology with thermodynamic methodologies or molecular dynamics simulations. When used together, these provide a powerful means to generate a greater depth of information than either can alone. Further, the ability to sensitively gauge kinetics and equilibrium information positions use of SPR as an adjunct to high-throughput screening and affinity ranking during lead optimization.

keywords: SPR, high throughput screening, lead optimization

On Page 1: Aiming to Optimize qPCR Steps

Progress in real-time quantitative PCR (qPCR) technology has been steady since its invention approximately 15 years ago. Representatives of different biotech companies and research organizations discuss recent innovations and where the technology is headed in the future.

keywords: qPCR, PCR

Point of View: How Is the FDA Really Doing?
By Henry I. Miller, M.D.
keywords: FDA, policy/legislation
Dr. Miller read with interest—and mounting skepticism—Patricia Dimond's Insight & Intelligence™ piece about FDA, “FDA New Drug Approvals in 2011 Outpace Recent Past,” on GEN's website. He explains why he feels some of its assertions and assumptions lacked essential context and disclosures.

Bioinstrument Manufacturers Go Global
By John Sterling
keywords: Policy/legislation, manufacturing

During President Obama's State of the Union speech last month, he called for revitalizing the U.S. manufacturing industry. Regarding the possibility of more manufacturing jobs actually coming back to the U.S., talks with biotech officials might lead one to conclude that the President just might be whistling in the dark and either does not understand or is ignoring the main reasons behind the establishment of regional manufacturing operations. They argue that calls for patriotism or nationalistic pride don't enter into the manufacturing equation and, from the business point of view, they shouldn't.

Biomarket Trends: As Fungal Infections Expand, so Does Market
By By Bruce Carlson
keywords: Fungal infections

A growing and aging population, increasing incidence of fungal conditions, the development and approval of new products, additional indications and formulations, and increased worldwide market penetration will be driving factors for the antifungal drug market over the next decade.

Corporate Profile: Firm Focuses Operations on Gene Silencing
keywords: Benitec, gene silencing, RNAi

Benitec, an Australian biotechnology company, holds a predominant patent position for silencing genes with DNA-directed RNA interference (ddRNAi). It is developing therapeutics to prove the validity of ddRNAi in treating cancer, infectious diseases, and disorders of the central nervous system.

Company Update: Protein Production Services Come Stateside
keywords: Contract manufacturing, protein production, Novoprotein Scientific

Novoprotein Scientific was among the early contract manufacturers of recombinant proteins, according to Huaxing Zhu, Ph.D., president and CEO. The company has expanded and now also produces and sells 500 off-the-shelf cytokines and recombinant protein products for research and manufacturing. Last year, Novoprotein opened a business development office in Short Hills, New Jersey.

Tutorial: Finding New, High-Quality Compounds
By Matthew Segall
keywords: Optibrium, StarDrop, medicinal chemistry

A suite of software for guiding decisions in drug discovery using predictive models and multiparameter optimization, StarDrop™ includes a plug-in module called Nova™ that specifically enables medicinal and computational chemists to automatically generate new compound ideas by applying transformations to their molecules in order to improve their properties.

Assay Tutorial: Membrane-Binding Studies with Living Cells
keywords: Molecular biology, SAW Instruments, biosensors

Several approaches exist to measure binding between a drug compound and its target. However, these techniques often involve radioisotope or fluorescent labeling, which may inhibit the antibody-target interaction in vitro and would not be used in vivo. In addition, many of these equilibrium techniques lack the temporal resolution required to facilitate accurate kinetic binding analysis, while another option, surface plasmon resonance (SPR), has only been able to work with purified receptors and membrane fractions. To address these limitations, SAW Instruments has developed the sam family of biosensor solutions for detecting and displaying biomolecular interactions in real-time.

miRNA Closes In on Therapeutic Potential
By Diana Gitig, Ph.D
keywords: miRNA, genomics, gene silencing

Although miRNAs were first identified in 1993, their importance as genetic regulators was not recognized for another ten years or so. Now it is estimated that the human genome encodes on the order of 1,000 miRNAs, and their prominent role as genetic regulators means that they are important players in many essential cellular processes. They have also been found to be misregulated in many disease states.

Getting the Most from Outsourced Projects
By Gail Dutton
keywords: Contract manufacturing, outsourcing, biomanufacturing

Making outsourcing an efficient and effective option for biotechnology manufacturing often is dependent upon innovation, a keen awareness of potential risks, and close collaborative relationships between CMOs and their clients.

Tutorial: Practical Interpretation of Equivalent Acceptance Criteria
By Keith M. Bower
keywords: Biomanufacturing, Amgen

A quality practitioner may be interested in assessing whether two process means are statistically equivalent, e.g., whether two processes (an historical process and a new process) produce equivalent results for a quality attribute. Statistical equivalency tests, e.g., two one-sided t-tests (TOST) are widely accepted as an acceptable method for demonstrating equivalency. In contrast with traditional hypothesis testing approaches, where the null hypothesis assumes equality across two parameters of interest (e.g., equal means), the null hypothesis using TOST can assess whether the average difference exceeds a comparability criteria known as the EAC (equivalency acceptance criteria).

Molecular Diagnostic Alliances Increasingly the Norm
By Josh P. Roberts
keywords: Molecular diagnostics, companion diagnostics

While molecular diagnostics may never completely replace “turn and cough,” it continues to gain prominence—from the companion diagnostics used to separate out potential responders to a specialty drug, to establishing a faster, more sensitive test for something as prevalent as tuberculosis.

Reformulations Must Provide Added Value
keywords: Formulation, reformulation

Reformulating currently marketed pharmaceuticals is a common way to both improve drug performance and manage the life cycle of a brand. In today's environment of constrained resources and rigorous formulary reviews, however, these new drugs must improve on the original beyond only dosing convenience. They should provide a new formulation that can improve bioavailability, pharmacokinetics, and/or route of administration with the goal of improving safety and/or efficacy for its intended use.