• A Functional History Of Process Validation, Part 1 – A Weak Foundation

    This article is the first of a two-part series that describes the origins of process validation to explain the underlying concepts necessary to control the advanced bioprocess manufacturing technologies required to make the next generations of biopharmaceutical therapies.

  • COVID-19’s Impact On Bioprocessing: Insights From Industry Leaders

    We interviewed 26 biopharma senior executives regarding how they are handling the crisis and its long-term impact on their operations. We found the pandemic has begun to catalyze and accelerate a number of significant changes, including many preexisting trends.

  • Regulatory Implications Of The CARES Act On Over The Counter Drugs

    The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed in response to the COVID-19 pandemic, reforms how OTC drugs are regulated in the U.S. In announcing the legislation, the FDA called the changes a “landmark step that will have an impact lasting long after the current public health emergency.”

  • Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering

    Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

  • Critical Thinking In Root Cause Investigations: Are You Asking The Right Questions?

    As we write or review a root cause investigation, it is up to each of us to challenge the information we are given and see if it stands up to having a critical light shined on it.

  • Lessons From An Outsourced Validation Project That Came Off The Rails

    I was recently hired by a sponsor company to support initiatives related to computer system, IT validation, and automation system validation. This article discusses my experiences and perspectives on this engagement, including best practices and lessons learned that other life sciences sponsor companies can apply in their interactions with their consultants.

  • 4 Skills An Exceptional Project Manager Can’t Survive Without

    Project manager can mean many different things to many people. To some it means passing a PMI-accredited test and being knighted into project management. To others it means running cross-functional meetings, issuing and following up on minutes and action items, and managing GANTT charts. And to others it means meeting key project milestones and budgets.

  • 5 Operational Priorities For Pharmas In The Wake Of COVID-19

    Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!


  • When Clean Is Critical—Understanding Parameters And Definitions Of Clean

    Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

  • Dye Ingress For CCIT: A Poor Bet In A High Stakes Game

    The dye ingress test method continues to be a widely used test method for Container Closure Integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this paper explains why the dye ingress test method is not a suitable approach.

  • Can You Afford Not To Outsource Buffer Preparation?

    The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

  • Labtainer Pro BPC Extractables Profile

    With the introduction of the Thermo Scientific Labtainer Pro BPC, Thermo Fisher Scientific offers a compilation of the standard BPC assemblies for use in conjunction with other bioprocessing products.

  • How To Avoid Last Minute CMC Roadblocks To Approval

    Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.




Whether you’re trying to coax a toddler into taking cough medicine or puzzling out how best to introduce a large-molecule biologic, each drug delivery scenario presents unique challenges. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.

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