Featured Bioprocessing Editorial

1. A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future 8/14/2020

   This article describes how process validation concepts can be evolved so the industry can better develop, manufacture, and launch the next generations of biopharmaceutical products.

2. CBER Takes On More Oversight Of Biologic & Biosimilar Master Files 8/11/2020

   This year saw a significant change in the process for submitting drug master files (DMFs) for biologic products: as of March 23, biologic-related DMFs are now administered by the FDA’s Center for Biologics Evaluation and Research (CBER). This transition of responsibilities presents a number of challenges for sponsors accustomed to working under the Center for Drug Evaluation and Research ( CDER).

3. Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products 8/11/2020

   The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.

4. A Functional History Of Process Validation, Part 1 – A Weak Foundation 8/7/2020

   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.

5. COVID-19’s Impact On Bioprocessing: Insights From Industry Leaders 8/5/2020

   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.

6. 3 Healthcare Changes Biosimilar Companies Must Prepare For 8/4/2020

   There are several changes I have been observing in the broader healthcare space that biosimilar companies must be prepared to consider to promote greater uptake of biosimilars and, in turn, greater cost savings.

7. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

   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.

8. The Case For Optimism In The U.S. Biosimilar Market 7/28/2020

   In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S. 

9. Critical Thinking In Root Cause Investigations: Are You Asking The Right Questions? 7/27/2020

   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.

10. Lessons From An Outsourced Validation Project That Came Off The Rails 7/24/2020

    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.