GUEST COLUMNISTS

• 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!