BioPharm International, June 2005 - BioPharm International

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BioPharm International, June 2005
Special Section
Downstream Processing of Monoclonal Antibodies: from High Dilution to High Purity
By Uwe Gottschalk, PhD
In a mere 30 years of development, a total of 23 MAbs and MAb-related proteins have been approved for medical treatments.
Columns and Departments
StreetTalk: Send Lawyers, Guns, and Money: My Patent Has Hit The Fan
By Brian O'Connell
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.
Book Review: Inside the FDA
By K. John Morrow, Jr., PhD
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.
From the Editor in Chief—Biopharm Moves Up A Rung On The Ladder of Worldwide Respectability
By Carol L. Fisher
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.
Outsourcing: New Financial Realities Will Alter Biopharmaceutical Outsourcing Landscape
By Jim Miller
Avariety of forces are combining to fundamentally change the financial dynamics of the biopharmaceutical industry. The initial public offering (IPO) appears to be giving way to licensing arrangements with, and acquisitions by, major pharmaceutical companies.
Final Word: NIH-Biopharm Interactions and the New NIH Conflict-of-Interest Regulations
By Howard A. Young, Ph.D.
. . . These new stringent rules will strongly impact the pipeline of scientific talent the NIH has provided the biopharm industry.
The Art and Process of Successful In-Licensing
By Ranan Lachman , Marc Samet, Ph.D.
Utilizing a measured approach can increase the probability for identifying search criteria that fulfill a company’s strategy.
The Susceptibility of CAPA to Subjective Bias
By Benjamin Locwin
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.
Regulatory Beat: New Policies Seek to Spur Biopharmaceutical Development
By Jill Wechsler
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.
Articles
The CRO Advantage: Outsource Clinical Trials to Launch Biotech Development Success
By Wendy Porter , Susan Krivacic
Less than 35 percent of all biotech companies have sufficient finances to survive beyond one year.
Chromatographic Purification of MAbs with Non-Affinity Supports
By Anu Subramanian, PhD
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.
Centralizing Compliance for Competitive Advantage
By Vega Finucan
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.
Cell Line Authentication Using Isoenzyme Analysis
By Raymond W. Nims, PhD , Christopher J. Herbstritt
Strategies for accurate speciation and case studies for the detection of cell line cross-contamination using a commercial kit.

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