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…
May 2011
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.…
Implementing a Single-Use Solution for Fill–Finish Manufacturing Operations
Fill–finish is the final operation in manufacture of sterile products (except for terminally sterilized products). This process requires sophisticated technology and machinery in a highly controlled, aseptic environment. Fill–finish assemblies must meet stringent requirements to ensure flow-path sterility and integrity, ensure operational safety and efficiency, and provide fill-volume accuracy to exacting requirements. Traditional fill–finish machinery comes as fixed systems comprising complex components that require assembly, cleaning and sterilization, disassembly, and material storage after filling is complete. Those operational…
Quality By Design and the New Process Validation Guidance
Where were you in 1987, and what were you doing? I’m not too embarrassed to say that I was beginning my last year of high school and paying far more attention to guitar lessons and writing my first novel than what I might eventually do for a career. Meanwhile, the US FDA was publishing a guidance document on process validation that the biopharmaceutical industry has relied on ever since. I’m willing to bet that quite a few readers…
A Case Study in Qualification of Single-Use Filling Manifolds for Particles and Endotoxins
Single-use technology is being examined for implementation in an increasing number of steps in the biopharmaceutical manufacturing process. Some examples of currently available disposable components include filter capsules, tubing, connectors, and biocontainers (for storage, mixing, and bioreactors), as well as devices for chromatography and multipass tangential-flow filtration (1,2). This technology was first implemented in upstream and API downstream processes such as media and buffer preparation, followed by upstream bioreactors and mixers (3). The single-use trend has most recently…
The New US Biosimilar Legislation, One Year Later
About a year ago, President Obama signed into law the highly publicized health care reform bill known as the Patient Protection and Affordable Care Act. This legislation included the new Biologics Price Competition and Innovation Act of 2009 (now a “biosimilar statuteâ€). Before enactment of that biosimilar statute on 23 March 2010, no “abbreviated†regulatory approval system existed in the United States for biologics — unlike Europe, which has had a system since 2005, and unlike US generic…
Adoption of Single-Use Sensors for BioProcess Operations
The increasing adoption of single-use technology in biopharmaceutical, vaccine, and cell therapy production is one indication that such technology has moved far beyond its novelty stage. Arguably, this is the preferred technology of newly developed processes. Benefits have been well documented in journals and conference presentations and have led the industry to form the Bio-Process Systems Alliance (BPSA). One current need is for process sensors that offer the same convenience as disposable bags, tubings, and filters being used. An ideal…
Won’t Get Fooled Again
The world loves a winner, and no one wants to be linked to a failed endeavor that could stall or otherwise negatively affect his or her career. If you’re reading this magazine, you’ve probably been inspected or audited by regulators and/or customers at some point. When it was finished, did your company compare favorably with expectations, or did the reports reflect a negative image? Did they mirror management’s view of operations, or was there a disconnect with management…
A Framework for Selecting and Working with a Normal-Flow Filtration Supplier
The biopharmaceutical market accounts for about 20% of the total market for pharmaceuticals, but its share continues to increase because of double-digit compound annual growth rates leading to projections that by 2014 eight of the top 10 best-selling drugs will be biologics (1). The industry faces many challenges and opportunities, as Jim Davies of Lonza Biologics explained to me: “Biomanufacturers have to contend with what is at present a dynamic technical and commercial landscape. Industry consolidation continues to occur as…
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…