Cover: Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines. This article provides an overview of key considerations for manufacturers of cell and gene therapies.
Features: Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, Massachusetts, 18–20 June. Future directions for the biopharma manufacturing industry were well represented by speakers from a range of environments.
Features: Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference.
Features: Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the 2019 ISPE Biopharmaceutical Manufacturing Conference, sharing information about groundbreaking work underway at Moderna.
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines.
Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical...
The November-December issue of Pharmaceutical Engineering is published in the months of the Thanksgiving holiday in the US and the year-end holidays celebrated around the world, so it seems appropriate to note the many changes to the magazine this year and give thanks to those who have contributed to and supported those changes.
I was recently meeting with one of the individuals I am lucky enough to call a mentor and friend. During our dinner, we talked about various topics from general life items to questions about work. One of the questions she asked that inspired me to write this article was, “If leaders are people with experience and wisdom, how can I be seen as a leader when I am just starting my career?”
Tracy L. Clemmer’s experience has spanned the globe, and she has an impressive list of ISPE roles on her résumé. In addition to being a past President and Chair of the Training and Education Committee of the ISPE Singapore Affiliate, she was a Board Member and Chair of the Training and Education Committee of the...
Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing...
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.
ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial...
Cleanrooms and laboratories can save a significant amount of energy by reducing airflow of air handling units (AHUs) after closing hours. Although challenging, airflow reduction is a successful energy reduction measure and has been implemented within the energy reduction program of Janssen Vaccines & Prevention B.V. in Leiden, the Netherlands.
The internet has led to an increase in e-commerce of prescription and over-the-counter (OTC) medicinal products; one in four adults has purchased medicines online.1
