BioPharm International-03-01-2021

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

Despite the persistence of the patent thicket, and slow uptake by the medical community, biosimilars are positioned for growth in the US.

Overcoming time and cost constraints can help enable seed train intensification efforts to maximize product yield.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Homology Medicines discusses how the clinical-stage biopharmaceutical company met its need for supply of adeno-associated virus vectors.

While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

Bio/pharma works hard today to change the calendar to tomorrow.

Auditing distribution suppliers provides understanding and documentation of the services performed.