Cover: There is much that large-scale commercial stem cell therapy processes can adopt from the existing bioprocessing industry. This article addresses some of the unique challenges posed by large-scale stem cell and stem cell–derived product manufacturing processes, and what should be considered while designing a manufacturing facility.
Feature: Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the pharmaceutical and biotech industries in recent decades. Although there is a great promise to treat and even cure many diseases with these products, there are also unique challenges, especially with their supply chains.
Feature: Facility design decisions made early in conceptual design can have a significant impact on the cost of goods sold (COGS) in the manufacture of autologous and allogeneic cell therapy products. Understanding the impact of a COGS analysis is an important aspect of the early-phase design process.
Technical: Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical, and medical device manufacturers leverage capability analysis along with other statistical quality control (SQC) techniques to enable timely supply of quality medicine to patients.
There is much that large-scale commercial stem cell therapy processes can adopt from the existing bioprocessing industry. This article addresses some of the unique challenges posed by large-scale stem cell and stem cell–derived product manufacturing processes, and what should be considered while designing a manufacturing facility.
Michelangelo Canzoneri, PhD, is a seasoned leader in the digital transformation space within the healthcare and life science industry currently serving as the Global Head of Group Smart Manufacturing at Merck KGaA, Darmstadt, Germany. In this pivotal role, he functions as the primary business interface across the life science, healthcare, and electronics sectors, steering the incubation,...
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements in recent years. The Emerging Leaders (EL) community from the Belgium and Germany/Austria/Switzerland (D/A/CH) affiliates collaborated to develop an inclusive series of online seminars on ATMPs. This article gives highlights of the speakers, topics, and knowledge shared in ATMP online seminars...
Erich H. Bozenhardt is the Associate Director of Process Engineering in Regenerative Medicine Operations at United Therapeutics. Erich is an experienced bioprocess subject matter expert and internationally recognized authority in the areas of cell and gene therapy and bioprocessing. He has published more than 30 technical papers and is a frequent presenter at conferences.
This is my last column in Pharmaceutical Engineering®. It has been my real pleasure and an honor to serve as your International Board Chair. Thank you for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.
We welcomed 2023 with high hopes and dreams of what Women in Pharma® could eventually be. As I prepare to conclude my time as the Chair of ISPE’s International Women in Pharma Steering Committee, I do so with immense gratitude.
As my first year on the ISPE Board of Directors draws to a close, I find myself reflecting on a year filled with unprecedented learning, growth, and valuable insights.
The 2023 ISPE Biotechnology Conference opened on 26 June with a series of six keynote presentations on biotechnology and the development and manufacturing of advanced therapies. Tom Hartman, President and CEO of ISPE, introduced each of the keynote speakers.
Since 2005, ISPE’s Facility of the Year Awards (FOYA) have recognized state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality...
Cell and gene therapy (C>) products comprise a rapidly growing field of innovative medicines that hold the promise to treat and, in some cases, cure diseases that are otherwise untreatable. In this article, we provide points to consider when evaluating the comparability of C> when changes are made in their manufacturing processes.
Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However, these living microorganisms are difficult to produce due to evolving government regulations and limited GMP manufacturing experience. New facility designs and more specific process guidance could help overcome these challenges. This article explores the nuances of facility design and regulatory...
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical, and medical device manufacturers leverage capability analysis along with other statistical quality control (SQC) techniques to enable timely supply of quality medicine to patients.
In August, ISPE unveiled a new Guidance Documents Portal that provides a significantly improved online user experience for ISPE’s full library of Guidance Documents.
Facility design decisions made early in conceptual design can have a significant impact on the cost of goods sold (COGS) in the manufacture of autologous and allogeneic cell therapy products. Understanding the impact of a COGS analysis is an important aspect of the early-phase design process.
Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the pharmaceutical and biotech industries in recent decades. Although there is a great promise to treat and even cure many diseases with these products, there are also unique challenges, especially with their supply chains.
Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are continually developed and pursued. The 2022 ISPE Pharma 4.0™ Emerging Leader (EL) Hackathon was designed based on innovator needs and provided a hands-on blueprint manufacturing exercise. Over a period of two days and facilitated by 40 subject matter experts, coaches, and jury members, 50...
