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  • The Long Arm of S88

    Batch automation standards are having an impact far from the control room, changing approaches to plant design, specification, and validation

  • Risk Management Still Eludes Vaccine Manufacturers

    Despite the buzz about "process understanding" and PAT, vaccine manufacturing remains defiantly un-PAT-able and an extremely risky business. Chiron's recent Fluvirin case offers important lessons in due diligence, quality management, and GMPs. However, it also points out an urgent need for incentives and regulatory flexibility.

    Agnes Shanley, Editor in Chief
  • Therapeutic Dose: Manufacturing Phil: A Drug&#39;s Life

    A Pfizer public education campaign and its cute mascot are praiseworthy, but neglect to mention the key stage in a drug's life. What will it take to make manufacturing a hot button issue and to better educate the public?

    Paul Thomas, Managing Editor
  • PAT Means Revolution — For FDA, Too

    PAT demands cultural change, not only within pharmaceutical manufacturing companies but also within FDA. Currently, the skills, training and background of FDA inspectors vary widely. Can they make the leap from the traditional chemistry-based quality approach to a future grounded in analytics and instrumentation?

  • Survey Sees Trends in Resource Allocation, Technologies

    At a recent Pharmaceutical Process Analytics Roundtable meeting, the latest results of a PAT survey of pharma and biopharma companies were released. In this exclusive article, PAT Insider examines findings and their implications for the future.

  • PAT: An Excipient Supplier&rsquo;s Perspective

    Although PAT is certain to change pharmaceutical manufacturing, it is difficult to tell how PAT will influence excipient manufacturing. Brian Carlin and Christophe Massip of FMC Corp. discuss how the company is using PAT to make its Avicel product, within the broader context of PAT in the pharmaceutical industry.

  • Question of the Month: Is Biopharma Ahead of the PAT Curve?

    For December 2004's PAT Insider, we posed the following question: Is biotech ahead of, or behind, the curve where PAT implementation is concerned? What are the biggest challenges that bioprocessing operations pose, and how can some of them be addressed? The response, from Ian Clegg and David Hughes of the ABB Centre of Excellence for PAT, follows.

  • Documenting the Journey: Assembling a PAT Dossier

    As Albert Einstein once said, “If you are out to describe the truth, leave elegance to the tailor.” A PAT dossier, describing your process from a scientific and technological standpoint, will be the log for your technical journey. This article summarizes what should go into this important record.

  • Explorations in Effusivity

    An annual effusivity seminar draws a standing-room-only crowd. Wyeth, AstraZeneca, Patheon, and USP share their research findings.

  • What Capacity Crunch?

    Is a cell culture capacity shortage likely? Biomanufacturers are still scratching their heads.

  • RFID Pilot Raises Hopes and Red Flags

    In Phase 1 of its "Jump Start" RFID project, Accenture identified pros and cons for drug makers. Now the firm and its project participants are gearing up for Phase 2.

  • Going Small, Thinking Big

    Microreactors and micro-scale equipment enable faster, continuous reactions, and are starting to make their mark in pharmaceutical manufacturing.

  • Broadening PAT's Manifesto

    The last word on PAT extends its use from a manufacturing to a cradle-to-grave tool for gaining process knowledge, FDA’s Ajaz Hussain says.

  • Don't Burn Your Bridges

    As the world evolves toward a paperless pedigree, RFID promises to be a key trace and track tool, but “bridge” and complementary technologies remain essential

  • Getting Past the Hype of RFID

    Not so fast—RFID is going to cost you. Both a new study by ARC and R4 Global Solutions’ CEO Jeff Richards discuss the issues

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