Regulatory Requirements for Biologic Drug Development

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.

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

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.

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

The Member Company Announcement Forum is the kickoff event of the annual DCAT Week in New York City, which is being held from March 17–20.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.