Industry Insights

  1. Critical Factors Of Fill/Finish Manufacturing For Biologics

    Unlike small molecule drugs, biologics are extremely sensitive, and therefore require specific handling procedures throughout the manufacturing process.

  2. Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.

  3. The Impact Of Waste On The Cost Of Quality In The Pharma Industry

    Waste has a significant impact on the cost of quality (COQ)—or more exactly, the cost of poor quality—in the pharmaceutical industry.

  4. Biosimilar Developers Must Scale Mountains of Data

    The U.S. FDA approved Sandoz’s filgrastim product, Zarxio, a biosimilar of Amgen’s Neupogen. This was a big step for the Agency, and one some feel was long in coming. The same product was approved for marketing in Europe six years earlier (under the name Zarzio).

  5. Which Laboratory Software Is The Right One For Your Lab?

    “Why do you need this laboratory information management system (LIMS)?” “We have an enterprise resource planning (ERP) system, why do we need to purchase yet another software product?” “How will the system you’re recommending improve lab operations?”

  6. Six Myths About Serialization

    Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  7. Divergent Approaches To Stem Cell Regulation

    Cell-based therapies are a challenge to regulators because they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro, and then administering in some form the expanded cells population back into the patient.

  8. Solutions to Today’s Biomanufacturing Challenges

    With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.

  9. Four Steps To Conducting A Successful Data Integrity Audit

    A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification.

  10. Applying QRM To The Change Control Process

    Since the publication of ICH Q9: Quality Risk Management in 2005 (1), there has been much written about the application of risk management to the production process, product development and validation (2–5). Relatively little has been published about its application to some of production’s supporting processes that comprise an important part of the pharmaceutical quality system (PQS).