May / June 2022

The implementation of a mammalian cell-based biopharmaceutical manufacturing process demands robust methods for knowledge handling, from early-stage development and technology transfer to production scale. Mathematical process modeling can summarize this knowledge as the relationships of critical...

Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols...

Advanced therapy medicinal products (ATMPs) pose specific manufacturing challenges beyond those typically addressed by pharmaceutical chemistry. Often in current ATMP applications, a change in approach is introduced at some point in the development process out of convenience or necessity, which...

The lack of diversity in the pharmaceutical engineering industry is widely recognized. Less well understood is why change is so hard to achieve. From my years of work in this space, and through observation of ongoing efforts to embrace diversity in all forms, I have developed a hypothesis: Progress...

Released in November 2021, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)–Autologous Cell Therapy focuses on manufacturing facility development and design for autologous cell therapies for parenteral use. This guide provides an overview of the critical aspects of ATMP facility design...

The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing...

Two sessions at the 2022 ISPE Facilities of the Future Conference in early February captured varied views of emerging technologies in the pharmaceutical industry, and the industry’s work to embrace these technologies.