November-December 2022: From the Editors

With this issue, we bid a reluctant farewell to our managing editor as she retires. Cheryl and I have known her and appreciated her friendship for 26 years. Her accumulated knowledge of cell and gene therapy development and the ease with which she can interpret the nuances of automation, digitalization, and equations will be sorely missed. To honor her time with us, I asked her to share her perspectives below. Maribel — it has been a thorough joy to work with you!

—S. Anne Montgomery

Maribel Rios,
BPI managing editor

At the end of BPI’s 20th year in publication, I find myself looking back through the different perspectives that many of you have shared in our issues this year and looking forward to new beginnings. Completing this current issue is bittersweet to me because after 26 years of working on pharmaceutical manufacturing publications (13 of those years at BPI), I am retiring. The opportunity to speak with many of you has been my favorite part of the job. The most memorable conversations have been what I like to call “doorway” discussions, when it feels like I’ve entered an entirely unfamiliar but fascinating room. Two of my early favorites were my first interview in 2000 with J. Craig Venter about the Human Genome Project and discussions with experts in academia for a 2001 article on the future of pharmaceutical industry education (which recommended that future students study bioinformatics).

When Anne invited me to reflect on the past 26 years for this editorial, I thought about what has (and has not) changed in the industry. Communication among collaborators, patients, industry suppliers, and (though some would argue only incrementally) regulators has improved over that time. The number of working groups and member organizations involving industry, academia, and regulators has grown, which has facilitated harmonization of regulatory requirements and improved compliance overall. That said, communication between the industry and the general population remains weak in many areas. Misunderstandings and fear of the unfamiliar among many people have led to hesitation, misinformation, and mistrust particularly with novel vaccines, as has been evident in the COVID-19 pandemic. The pharmaceutical industry still suffers from a public-relations problem. Drug companies emphasize repeatedly that they focus heavily on the needs of patients. But whether that message has been made clear is debatable. More work is needed to clarify for the general public all the steps that are taken to ensure drug safety and high quality.

Time, cost, and funding pressures continue to weigh heavy on the biopharmaceutical industry. Developers and manufacturers always have been in a race to clinical testing and commercialization. Unfortunately, doing more with fewer resources and within shorter timelines is part of the job, as it is in many sectors. That is especially true for developers of cell and gene therapies, who must work within the narrow vein-to-vein timeframes for patients who suffer from quickly progressing diseases such as cancer. In a September 2022 presentation at Biotech Week Boston, Mike Lehmicke of the Alliance or Regenerative Medicine pointed to the need for funding and investments in cell and gene therapies.

The industry’s focus on good science and risk mitigation continues and must remain the foundation upon which all work is based. Increasing attention to risked-based approaches and implementation of innovative methods based on science and proof of sound drug-product quality, safety, and efficacy has improved efficiencies in biomanufacturing. Especially after the FDA introduced its Pharmaceutical Quality for the 21st Century paradigm, the past quarter century has brought widespread adoption of quality by design (QbD), elimination of “silos” in development, definition of design spaces and critical quality attributes, incorporation of design of experiments, and recognition of critical process parameters. Considering quality early in development (even at the research stage) has become an essential strategy.

The science- and risk-based approach to development and manufacturing also has led to several innovations over the past 26 years. Many participants in BPI’s 20-year anniversary issue highlighted single-use technologies, standardization, automation, and digital applications as major game changers. Other disruptive technologies could include gene editing, cell-free synthesis, modular and closed manufacturing, robotics, bioprinting, new lyophilization methods, connected and integrated platforms, single-cell analysis, membrane-based filtration, miniature bioreactors, feedback control solutions, optimized media, and monitoring systems for use throughout biomanufacturing processes.

Such innovations are initiating novel manufacturing approaches. Intensified production with continuous and perfusion systems now run within open, closed, or semiclosed environments. Manufacturing is becoming more sustainable within smaller environmental footprints. Encouraging investigations into smart manufacturing, predictive modeling, and control strategies combined with new tools such as digital twins and data-driven approaches to identify ideal process conditions could minimize variability to levels lower than ever before. Forward-looking platforms and integrated systems are enabling biomanufacturers to evaluate their processes holistically. And current digitalization efforts toward machine learning and ultimately the full use of artificial intelligence promise to advance the industry down new pathways.

I have been the most fortunate person to have had a front-row seat to such developments. I thank you for the lively conversations, the advice, and the education. To the BPI family, you are some of the best people I have ever had the privilege to know and work with. Best wishes for a prosperous 2023 and beyond.