Data Integrity Challenges in Manufacturing

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

The addition of the two larger-volume bioreactor sizes to Cytiva’s Xcellerex X-platform portfolio will allow scientists and researchers to scale up from 50 L to 2000 L to meet growing demand for clinical trials and regulatory approved products.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

PharmTech Group chatted with Markus Laubscher of Orbia during DCAT Week 2025, covering the topics of sustainability, regulatory hurdles, next-generation innovation, and the DCAT Week experience.

EsoBiotec’s proprietary lentiviral platform primarily enables the immune system to attack cancers but could ultimately offer patients cell therapy treatments delivered in minutes rather than several weeks.