May 2011

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 statute”). 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…

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…