2010

How Pore and Fibrous Interstice Structure Influence Filter Performance

    A common objective in pharmaceutical processing is the removal of solids from fluid suspensions through filtration. The usual purpose is the removal of the solid particles to a specified extent, within a given time interval, at the largest possible throughput. Attainment of those goals is managed by proper selection of filtration conditions: principally an adequate effective filtration area (EFA) as defined by filter porosity and a proper rate of flow as regulated by applied differential pressure (ΔP) over…

Effect of Sterilization on the Mechanical Properties of Silicone Rubbers

    Silicone rubber is widely used in the pharmaceutical industry, where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products are sterilized frequently and repeatedly by high-level energy and/or chemical vapor to eliminate bacterial surface contamination. Such treatments may also affect the molecular structure of silicone rubbers, causing changes in their physical properties and performance. Several studies on this topic have been reported; until now, however, no systematic investigation has been performed on the effect of…

Isolation of Novel High-Osmolarity Resistant CHO DG44 Cells After Suspension of DNA Mismatch Repair

    Recent technological advances in cell line and bioprocess development have driven significant improvements in product titers and enabled scientists to accelerate product development timelines (1). Despite those successes, many limitations in developing cell lines for biotherapeutics remain. One example in fed-batch cultures is an apparent paradox: when cell growth is inhibited by high osmolarity after multiple additions of concentrated nutrients intended to enhance cell growth and protein production. Generation of novel host cells to overcome specific bottlenecks found…

Global Marketplace

Small-Scale Fluid Control Product: Flipper 6650 solenoid valve Applications: Analytical fluid dosing Features: With a pitch of only 4.5 mm, the Flipper 6650 solenoid valve comes in 2/2- and 3/2-way versions that offer performance comparable to 10-mm and 16-mm valves. The media-separated valve is compact and fast-switching, optimized especially for reproducible and precise dosing of aggressive fluids. Because of its compact size, the valve requires smaller internal volume in the connecting plates, thus increasing efficiency of media use, which can…

TIDES® Oligonucleotide and Peptide Technology and Product Development

Moving to Boston, MA, after four years in the western United States (Las Vegas and Carlsbad, CA), the Tides conference continues to be the must-attend event for the industry that grows in attendance each year. The 2010 agenda includes thought-provoking keynotes and featured presentations, a compelling regulatory session, and discussions with CBER, FDA, and European regulatory agency speakers. In separate tracks for each type of molecule, learn more from the new, full-day sessions on CMC manufacturing and analysis and a…

Making a Positive Urban Impact

Like so many other midwestern industrial cities, St. Louis, MO, saw its manufacturing base decline over the past 40 years. Led by the automobile, shoe manufacturing, and defense industries, that decline was coupled with a notable decrease in the city population. From 1950’s high of 850,000 people, the city dwindled to ~350,000 by the 1990s, although its metropolitan area grew to >2,000,000. Accelerating growth of high technology in the 1990s had minimal impact on St. Louis the “old industry” the…

The Growing Role of Biobanking in Today’s Medical Environment

    For decades, biomaterials such as tissues, blood, and serum derived from clinical testing have played a critical role in drug development and academic research. The recent focus on molecular-based therapies, genomics, and biomarker discovery in today’s medical research have dramatically transformed the way biotechnology and pharmaceutical organizations collect, transport, and store their biospecimens. As the pharmaceutical industry shifts toward a more personalized approach to medicine, the need for high-quality, well-maintained biospecimens is at the forefront of medical research.…

Managing the Product Pipeline

    In 2007, the biopharmaceutical market represented ~$71 billion: 10% of the entire pharmaceutical market. Therapeutic proteins and monoclonal antibodies (MAbs) account for 98% of all biotherapeutics in development, the rest being blood proteins and enzymes — all the products of recombinant DNA technology. Before the recession hit full on, growth of this market was estimated by some at ~15%. (Now it’s hard to predict at all.) Making biotech drugs consumes huge amounts of time and money, but they…

Delivering Affordable Biologics from Gene to Vial

    In launching this new series of articles under the theme of delivering affordable biologics, from gene to vial, we intend to examine some of the challenges the bioprocess industry faces. We will discuss the implications of key cost challenges facing the industry, develop an understanding of the economics underlying development and manufacturing, and explore options for driving out cost. We wish to encourage dialogue and debate, so in addition to the articles we will also use webcast interviews…

The Business of Biotechnology

    All companies — large and small, biotech included — have felt the pinch of the current (or recent, depending on your point of view) recession. From huge multinational companies to virtual start-ups, all are taking a good hard look at the way they do business. And as it does every year, the 2010 BIO International Convention will offer something for every company and every situation. Business-oriented sessions range from hard-earned experience to provocative new ideas. On the BioProcess…