Applying smart, continuous manufacturing to biopharmaceuticals ultimately requires detailed digital models for each unit operation. Although the industry is moving toward that goal, achieving ...

Determining the critical quality attributes (CQAs) of emerging, more complex nucleic acid (NA) therapeutics and their carrier systems poses a new challenge for biopharmaceutical companies. Low ...

The US Food and Drug Administration (FDA) on Monday finalized draft guidance that provides manufacturers of chewable tablets with current thinking on the critical quality attributes that should be ...

This study presents a comprehensive approach for assessing multiple quality attributes of antibody-oligonucleotide conjugates.

In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications ...

Adopting a Quality by Design (QbD) approach for wet granulation requires manufacturers to comprehend the correlation between process variables, such as powder characteristics and equipment ...

The approvals of Roche’s Luxturna® (2017) for inherited retinal disease and Novartis’ Zolgensma® (2019) for spinal muscular atrophy are indicative of a resurgence in the gene therapy field after a ...