Quality/GMPs

Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.

I was playing tennis recently with my friend Ron who, in addition to a wicked backhand, is well-versed in new technologies and gadgets.

FDA plans to conduct good manufacturing practices (GMP) inspections of flu vaccine manufacturers annually instead of every two years.

One of the very last sessions on the very last day of BIO 2005 drew quite a crowd. It was titled, "The Five Worst Mistakes You Can Make When Creating a Collaboration or Strategic Alliance."

When data are not normal, a more efficient approach to monitor and control the performance of this assay requires transforming the data to a normal distribution. One of the most useful transformations was invented by Taguchi.

Cell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.

The manufacturer should propose stability-indicating methodologies that provide assurance that changes in the identity, purity, and potency of the product will be detected.

Web-based asset performance management provides pharmaceutical manufacturing with a number of advantages over traditional asset maintenance and tracking.

Reading about the sophisticated advances in biotechnology is now a common, enlightening occurrence. But the field certainly has taken its lumps over the past three decades, creating doubts in the minds of investors and periodically striking fear in the hearts of the public. Take the late-night sci-fi thriller I awoke to one evening, where an army of diseased and highly intelligent rats was infiltrating a stalled subway car filled with terrified passengers. Of course, the animals were sick, smart, and reproducing offspring with similar attributes because of an experiment-gone-awry in a biotech lab — they'd been treated with some kind of therapeutic grown in a rare plant — which was now abandoned after its occupants received one too many warning letters from "a regulatory agency." THAT woke me up real fast.

Our society's penchant for prescription drugs has torn a gaping hole in our collective wallets. According to the US government, overall US health spending has risen to $1.9 trillion in 2005.

The least we can do in our industry to ensure scientific integrity in our pursuit towards effective CAPA is to have our data peer reviewed.

In March of 1932, socialite and millionaire playboy Eben M. Byers died of a horrible and mysterious disease, his body corroded until his bones began to shatter apart. Strikingly handsome in his youth, by the time of his death a series of last ditch operations had eliminated the lower part of his face and reduced him to a distorted shadow of his former self. His bizarre death was the result of his addiction to a quack cure, radium-laced water.

As the bustle of Sarbanes-Oxley (SOX) 2004 compliance deadlines for companies winds down, executives have an opportunity to reconsider their company's compliance strategy.

Last year's catastrophic flu vaccine shortage and escalating Congressional debate over drug safety continue to shine the spotlight on biotech product manufacturing. FDA officials are under pressure to address concerns about access to quality biotech products, while also encouraging the development of new treatments to meet patient needs.

An anionic column with modified chitosan bead matrix performs well in purifying cell culture. A pair of cationic-exchange columns shows promise in purifying S25 antibody.

Utilizing a measured approach can increase the probability for identifying search criteria that fulfill a company’s strategy.

Cancer remains the primary indication (three products), again mirroring recent approval trends.

Saturated fractional factorial plans minimize the number of trials by one-half or better, which saves time and money.

Despite the ringing of two stray cell phones disrupting the quiet, all eyes and ears were glued, almost reverently, on New York City's former Mayor Rudy Guiliani at INTERPHEX when he presented the day's keynote address. First, he thanked the audience for providing the therapeutic options that allowed him to successfully defeat prostate cancer awhile back. Next came his imitation of James Gandolfini in the hit TV show "The Sopranos," as he reminisced about his duties as NYC's former chief prosecutor. Once he had our full attention, close to 1,000 of us, he shared what he felt are the most valuable leadership attributes and how they will successfully get you through challenging and uncertain times.

Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis.

$200 million and two years could be shaved off a drug's development time by using informatics effectively.

Geron rose 7% and StemCells 15% . . . when news of the New York capital funding effort hit the business pages.

FDA will allow nonprescription NSAIDs to share the market with products carrying black-box warnings.

You don't really care what people say about you (the biopharm industry) behind your back, do you? According to a recent survey of 670 BioPharm International subscribers, conducted by Derek Ellison from Eden BioDesign, some of you care very much about the public's perception of the industry.

During the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts.