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,…
Business
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In November 2008 the US FDA finally issued a new draft guidance on process validation (1).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.…
Q&A with Dr. Florian Wurm
In early April, I chatted with the chair of ESACT, Florian Wurm, a professor of biotechnology in the faculty of life sciences of école Polytechnique Fédérale de Lausanne in Switzerland. As chairman of ESACT, what are your duties? How is the chairperson selected, and how long does he or she serve? How long have you been chair? The ESACT chair is elected from among the members of the executive committee, which are elected by the membership. The executive committee organizes…
A Few Small Steps for Biotech Will Yield Giant Leaps for Humankind
Biotechnology’s mission has never been more critical. In a call to action reminiscent of President Kennedy’s challenge to place a man on the moon in the 1960s, President Obama has challenged the scientific community to seek “a cure for cancer in our time.” The challenge is tremendous, but the place to look for such a momentous and meaningful achievement is among the great minds of scientists and inside the research laboratories of biotech companies. And that is but the tip…
FDA 21 CFR Part 11 Revisited
Six years after the US FDA applied a narrower scope to its interpretation of 21 CFR Part 11 on electronic records and signatures (1), the agency is ready to release the revised Part 11. The 2008 release of a draft revision of Annex 11 — Europe’s version of Part 11 (2) — put pressure on the FDA to complete its long-overdue Part 11 revision. As I made clear to members of my SmarterCompliance executive advisory group in May of last…
Sailing Through Pharmaceutical Risk Management
Trends in Single-Use Bioproduction
Most people in the biopharmaceutical industry recognize, at least anecdotally, that the use of disposables in biomanufacturing is moving forward. At BioPlan Associates, we’ve tried to quantify how things are advancing and capture some of the shifts in attitudes, especially in light of current economic challenges. The major shift is that decisions are being made more from an operational point of view. It’s become less a question of if disposables will be implemented than of where and how.…
Ratiometric Photometry Improves Laboratory Quality Assurance
Laboratory scientists often assume that their liquid-handling instruments, from pipettes to automated liquid handlers, are operating within specification. But given that data integrity for applications from drug discovery to molecular diagnostics relies on accurate and precise liquid delivery, that can be a very risky assumption with high costs of failure. Those costs and risks are compounded by several trends in today’s life-science laboratories, such as the growing use of valuable reagents at low volumes and an increasingly strict regulatory environment.…
Encyclopedia of Rapid Microbiological Methods
Many different rapid microbiological methods (RMM) have been developed in recent years, although their acceptance and implementation in the pharmaceutical industry has been slow. To stimulate the integration of RMMs in the pharmaceutical industry, the Food and Drug Administration (FDA) introduced the Process Analytical Technology (PAT) initiative in 2004. A year later, the Encyclopedia of Rapid Microbiological Methods, edited by Michael J. Miller, was published. Miller, senior research fellow in the manufacturing and science department at Eli Lily, recruited many…
Growing the Future
No segment of the biotechnology industry has received more public scrutiny than agricultural biotech — except maybe its application to food. And none has been subject to more “hype†and high hopes for instant results than biofuels. By contrast, industrial biotechnology seems almost invisible to the public at large. In general, the more immediate the effects on consumers, the more likely they are to pay attention and either laud or loathe the associated technology. The general public…