2011

Are Single-Use Technologies Changing the Game?

Recently, I have heard the term game changer used to describe single-use technologies (SUTs). Whether this is hyperbole or reality remains to be seen. But it does bring baseball to my mind. After all, it’s finally spring, games began in April, and optimism reigns supreme — at least in some major-league cities. I was struck recently by an article in my home-town Washington Post by venerated columnist Thomas Boswell, who wrote in March about hope for the future of our…

NIR Spectroscopy Analysis of Phosphate Salts

Confirmation of raw material quality is a vital part of biopharmaceutical manufacturing processing. Incorrect or poor-quality vendor materials account for a considerable portion of failed and recalled product. To prevent these expensive problems, strict quality control (QC) procedures are often implemented and used to screen for inappropriate incoming materials. QC procedures commonly used are chemical tests that involve removing samples to a laboratory and performing, which can at times be complex, time-consuming, and laborious protocols. A common test procedure that…

Productivity Bottlenecks Drive the Demand for Innovation

    Spending is up, the global economy is slowly getting back on track, and the biopharmaceutical industry continues to roll along at double-digit growth. Productivity has been the primary industry focus over the past few years, and it remains a hot topic. Companies are aggressively going after the bottlenecks to their efficiency, and now they’re opening their wallets to fix what’s broken. One of the biggest productivity fixes today centers on improved single-use devices and systems. They top a…

Working with a Powerful and Robust Mixed-Mode Resin for Protein Purification

    Orthogonal methods for assuring robust downstream purification are critical to today’s demanding downstream process industry. Regulatory scrutiny on the immunogenic propensity of drugs has increased and broadened over the past two decades. Although immunogenicity can come from a number of sources, common concerns include host-cell proteins and aggregates. Constantly lurking in the background are other issues such as viral clearance, DNA levels, and so on. Those problems can be addressed simultaneously with the mixed-mode chromatographic support known as…

Global Marketplace

Shaker–Incubator Product: Multitron II system with shaker-bag option Applications: Cultivation of mammalian, insect, or plant cells Features: A Multitron II unit (50-mm orbit) with shaker-bag option enables 1- to 10-L cell cultures in disposable bags. Direct gassing of air or air–CO2 mix provides pH stability, and media temperature is controlled by air inside the incubator chamber. Up to three 2-L or two 10-L bags, or one 20-L bag from a number of manufacturers can be accommodated. The system also works…

Disposable Bioreactor Sensors Play Catch-Up

The evolution of single-use bioreactor (SUB) systems in biologics manufacturing has been rapid and influential. Reliance on efficient and flexible bioreactor technology will be critical for reducing scale-up costs and facility capital expenses as well as aggressively growing biotherapeutic and monoclonal antibody production. The biopharmaceutical industry has seen considerable growth in the proliferation of single-use bioreactor platforms as well as manufacturing areas where these systems are applied. Need for Improved Single-Use Sensors As disposable technologies are widely accepted and established,…

From the Editor

        Bonjour! I am writing this from Nice, France, on the last day of the eighth annual BPI European Conference and Exhibition organized by our London-based Informa Life Sciences colleagues. Despite the attraction of some exquisite spring weather (a welcome respite for me from the rain-drenched Pacific Northwest), sessions were well attended till the very end, and discussions were lively and productive. This event was organized into five tracks: manufacturing strategies, process optimization, economics and QbD; cell…

Improved Downstream Technologies Are Needed to Boost Single-Use Adoption

Greater adoption of single-use systems in biomanufacturing is going to require downstream device innovation. To get there, over a third of the biopharmaceutical industry is demanding that suppliers innovate and develop new single-use purification devices, according to BioPlan Associates, Inc.’s annual survey of biopharmaceutical manufacturing capacity (1). Such new products would create exceptional opportunities for innovators. However, calls for new, more fully integrated single-use technologies and processes will require more adventurous innovation on the part of biomanufacturers and their suppliers.…

Disposable Downstream Processing for Clinical Manufacturing

Although disposable parts and modules have been used in the biopharmaceutical industry since the 1970s, as detailed in the “History” box, total disposable manufacturing has become a viable option only very recently. Whereas liquid storage became disposable in the 1990s, processing operations such as depth filtration, tangential-flow filtration (TFF), and chromatography have still required skids with reusable flow paths that needed cleaning and sanitization. Important recent milestones in total disposable technology included introduction of stirred bioreactors by HyClone (Thermo Scientific)…

New Plant Expression Systems Drive Vaccine Innovation and Opportunity

Plant expression systems are emerging as fast and inexpensive methods for producing vaccines. Someday, plants may surpass mammalian and even many microbial systems in efficiency and cost-benefits for the manufacture recombinant proteins. This is particularly so for the rapid manufacture of truly large-scale (million- or even billion-dose) vaccine antigens. Whether grown as single cells or tissues in photosynthesis reactors, as whole plants in controlled laboratory situations, or cultivated in fields of transformed food-commodity plants (e.g., rice, potatoes, or tobacco), plants…