Articles

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  • Demystifying Multivariate Analysis

    In order to identify sources of process variability, you need to be able to integrate information ranging from raw material and intermediate measurements to processing and environmental data. Multivariate analysis techniques such as principle component analysis (PCA) and partial least squares (PLS) can be highly effective. Chris McCready, an engineering specialist with the software firm UMetrics, shows how MVA methods can be applied to improve your process IQ.

    02/24/2005
  • J&J Looks at Stable Isotopes for Process Analysis

    Stable isotopic analysis is already being used in pharmaceutical and raw material authentication, but spectrometry based on the technique promises to become a useful PAT tool. In this exclusive interview, John Jasper, CSO of Molecular Isotope Technologies, discusses the technology with Managing Editor Paul Thomas. (An article in April’s Pharmaceutical Manufacturing will discuss work under way at Johnson & Johnson.)

    02/24/2005
  • Rick Cooley Puts PAT in Perspective

    A pioneer offers his perspectives on PAT and where it’s heading and reminisces about his 23+ years leading Eli Lilly’s process analytics program. His advice: Remember that PAT won’t magically lead to headcount reduction; it isn’t always easy to do, and you can (and should) start small! Before starting a new position as North American manager of process analytics with the chromatography vendor Dionex, he shared his views with Editor in Chief Agnes Shanley.

    02/24/2005
  • Pfizer Goes On the Offensive

    Even before Peter Rost testified in favor of reimportation before a Senate committee, Pfizer SVP Chuck Hardwick had fired off this letter to Senate Committee Chairman Enzi, arguing that reimportation endangers the U.S. drug supply and the public.

    02/16/2005
  • Dr. Rost Goes to Washington

    Did you know that one leading drug company's CEO recently sent a memo to its U.S. employees urging them to buy generics? This is only one of several conflicted industry positions pointed out by Pfizer marketing executive Peter Rost. On February 16, Rost testified before a Senate Committee -- not as a Pfizer employee, but as a public citizen. In this transcript, he argues that reimportation would only benefit the U.S. public.

    02/16/2005
  • Peptides Prepare for Takeoff

    Some 40 peptide drugs are on the market today, but hundreds are in the pipeline. Get ready for a new era for biopharmaceuticals, says a new report by Frost & Sullivan. Read our conversation with analyst and report author Himanshu Parmar, then download the executive summary to receive more details and figures.

    02/16/2005
  • Nine Steps to Pharmacovigilance

    Drug firms today must create comprehensive drug safety strategies amid an ever-changing regulatory environment. Matthew Boyd, senior counsel with Holland & Knight, provides nine must-dos for pharmaceutical firms.

    02/16/2005
  • Therapeutic Dose: The Scruffy Guy Cometh

    Director Michael Moore is pointing his lens toward the pharmaceutical industry, and drug company employees are on high alert. Love Moore or hate him, enjoy the limelight while it lasts, says Managing Editor Paul Thomas. Besides, an encounter might also be an opportunity to talk about the positive work you're doing.

    02/16/2005
  • Downstream Bioprocessing: More is More

    What's good for upstream processes -- higher concentration levels for MAbs and proteins -- can strain downstream operations, forcing manufacturers to rethink the purification train.

    02/16/2005
  • 13 Qualities to Look For in a Systems Integrator

    A successful project can hinge on finding the right engineering services firm, says John Sever, president of Cascade Controls, Inc. Here are 13 things you should consider before making a selection.

    02/16/2005
  • Achieve Success with Biosimulation

    Biosimulation, if done right, aids in allocating equipment, managing utility requirements and optimizing processes. Here's how to apply simulation to improve purification.

    02/16/2005
  • How Pharma Can Find RFID's ROI

    Before they can embrace RFID and integrate it into their enterprise IT systems, pharmaceutical manufacturers must grapple with several key issues, including how to justify the ROI. In this exclusive interview, SAP's Jim Sabogal discusses problems firms are having with RFID, and strategies that SAP has in store.

    02/10/2005
  • Isotope Analysis Expands Its Forensic Niche

    Remember isotopes from Chemistry 101? As used in Stable Isotope Analysis, they offer a surefire way to authenticate APIs and products without additives. John P. Jasper, who helped pioneer the technology, discusses what it can do and where it's heading.

    02/09/2005
  • Pedigree Tags Need HF; FDA Agrees

    Pedigree RFID tags can never take off unless HF (13.56 MHz) becomes the norm; FDA appears to realize this, and is leaning toward HF at the unit level. Bert Moore of AIM Global discusses this situation.

    02/09/2005
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