June 2009

A Presanitized, Purpose-Designed, Single-Use TFF Strategy

    For many years, biopharmaceutical manufacturers have worked to increase capacity, address upstream production issues, and improve product yields. Notable successes recently achieved in upstream technology have significantly increased expression rates and therefore, upstream production capacities. Successes in generating higher titers combined with increasingly stringent quality and regulatory requirements have led to a number of challenges in aligning the efficiency of downstream processing with upstream titers. It is generally recognized that downstream processing costs account for about 70% of…

Applying Intelligent Flow Microscopy to Biotechnology

Ongoing requirements for additional insight and CGMP-compliant measurement have led to interest in new technologies that can be applied to the analysis of many different types of particle-containing fluids. Micro-Flow imaging (MFI) is a robust, versatile, and intelligent vision technology that is increasingly used for evaluating populations of microparticles encountered during bioformulation development (1). It is also being accepted in fill–finish processes and many other biotechnology applications. Features of MFI technology that have contributed to its rising popularity include the…

BioProcess International Conference and Exhibition

IBC’s BioProcess International Conference and Exhibition (BPI) will head back to the US east coast for 2009 to Raleigh, NC. This has become the largest, most respected forum focusing on technical, regulatory, and strategic planning challenges in the manufacture of biotherapeutics. Four comprehensive conference tracks as well as intimate workshops, strategic discussion groups, training seminars, and colocated conferences will continue to provide you with an interactive and lively format all in one location. BPI allows you to meet face-to-face with…

Global Marketplace

Custom DNA Product: McBox luc minicircle and plasmid DNA Applications: Transfection optimization Features: The McBox luc kit includes 100 µg each of certified minicircle and plasmid DNA, both including the firefly luciferase reporter gene. A vial with endotoxin-free water for injection ensures high quality after dilution. Scientists can now directly compare minicircle DNA with a corresponding “classical” plasmid in individual applications. Minicircle DNA contains almost exclusively the gene of interest and its regulating sequence motifs. This provides a safe and…

New Validation Guidance Causes a Stir

In November 2008 the US FDA finally issued a new draft guidance on process validation (1). The original guidance on this topic was published in May 1987, and the FDA explained that “since then, we have obtained additional experience through our regulatory oversight that allows us to update our recommendations to industry on this topic.” The new guidance is intended to reflect some goals of the FDA’s Pharmaceutical GMPs for the 21st Century, an initiative that was finalized in 2004.…

Setting the Stage

Much has already been written lately about addressing the so-called “downstream bottleneck(s).” A number of companies are leading the way toward developing products and platforms for reducing both the costs and the time required for downstream processing. Our task with this special issue was to provide a state-of-the-art update on these activities — but as always, within a limited number of pages allotted. The primary issue behind this bottleneck debacle is to address purification challenges posed by aggregation in cell…

Patents, Politics, and Polypeptides

Humor columnist Dave Barry once opined, “Without question, the greatest invention in the history of mankind is beer. Oh, I grant you that the wheel was also a fine invention, but the wheel does not go nearly as well with pizza.” Certainly, few biological concoctions have achieved that level of popularity — but with a little luck, your company will produce at least one invention with the potential for measurable success in its target market. But with success comes competition,…

The Road to a Fully Disposable Protein Purification Process

    What’s keeping senior biopharmaceutical executives awake late at night? According to BioPlan Associates, Inc., which publishes an annual comprehensive survey of the state of worldwide biopharmaceutical manufacturing, capacity constraints are among the key issues at hand (1). And one of the most important constraints is the lack of physical capacity in purification equipment. Bioreactors are producing a lot more protein than current downstream purification steps are designed for. Overcoming the resulting bottlenecks may require increasing the productivity of…

Making Your Way to Excellence

    As organizations launch operational excellence (OpEx) programs, they are faced with challenges that must be overcome before they can achieve true excellence. One of the largest barriers to overcome is employee perception. The first step is to provide training that will energize employees and change their understanding of what operational excellence can do for them and their organization. For this reason, Bayer has developed an OpEx fundamentals training that starts with the “heart and mind,” focusing on less-threatening…

Single-Use Strategies in Bioprocessing

BioProcess International has followed, from the beginning, the ways in which single-use technologies have transformed the landscape of industrial bioprocessing. On 18 March 2009, we organized a panel session at the annual Interphex conference (Jacob Javitz Center, NYC) to drive discussion toward longer-term implications of single-use components and technologies on the future of bioprocessing. Is their use a cost-saving strategy overall? What economic factors are driving their adoption? The panelists were prepared to address such topics as economic considerations in…