Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
Biosimilars Hit Their Stride
Despite the persistence of the patent thicket, and slow uptake by the medical community, biosimilars are positioned for growth in the US.
Jumping Seed Train Intensification Hurdles to Maximize Yield
Overcoming time and cost constraints can help enable seed train intensification efforts to maximize product yield.
Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing
The need for real-time monitoring and control has spurred the development of new analytical tools.
Finding Success in AAV Manufacturing
Homology Medicines discusses how the clinical-stage biopharmaceutical company met its need for supply of adeno-associated virus vectors.
Increases in Manufacturing Capacity Target Vial and Syringe Shortages
While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.
Toxicology: Ensuring Drugs are Safe for People
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
FDA Documents Achievements and Plans for Future
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
Fighting Through This Slow Season of Change
Bio/pharma works hard today to change the calendar to tomorrow.
Auditing for Good Distribution Practices
Auditing distribution suppliers provides understanding and documentation of the services performed.
