David O Dornan

Mar 7, 2024 | bioprocessintl.com | Cheryl Scott |Tian Lan |Brian Gazaille |David O Dornan

Regulatory compliance cannot be an afterthought when you apply artificial intelligence, machine learning, and other advanced information technologies to biopharmaceutical development and manufacturing. The authors in this eBook encourage readers to keep product quality (as well as business concerns) in mind, using agile methodologies and good automated manufacturing practices while embracing the bioprocess 4.0 paradigm.

Feb 22, 2024 | bioprocessintl.com | Brian Gazaille |David O Dornan |Christopher Nasveschuk

eBook: ADC Advances — Leveraging Classical and Emerging Technologies Between 2000 and 2019, the US Food and Drug Administration (FDA) approved only four antibody–drug conjugate (ADC) products for commercial distribution.

Feb 22, 2024 | bioprocessintl.com | Brian Gazaille |David O Dornan |Christopher Nasveschuk

Between 2000 and 2019, the US Food and Drug Administration (FDA) approved only four antibody–drug conjugate (ADC) products for commercial distribution. Between then and 2024, however, the number of marketed ADC products has swelled to 13, and clinical studies are underway for more than 100 candidates that address nearly 40 indications, mostly in oncology. Recent successes might seem to have come suddenly considering the previous dearth of approvals.