Safety First: Methods of virus inactivation for increased safety of advanced therapies

Regulatory agencies around the world have been steadily increasing pressure on cell, gene, and tissue-engineered drug development companies to put safety first and find ways to control the inherent risks present in many of the raw materials used in the downstream processing of their advanced therapies. The industry has been largely transitioning away from animal-derived

Human-Derived Plasma Ancillary Materials for Cell Therapies: What Virus Inactivation Methods Should You Consider?

Human plasma is defined as “clear, straw colored, complex liquid that is 7% protein, 91% water, and 0.9% mineral salts” and can be derived from Source or Recovered Plasma. Today, human plasma is used to produce several ancillary materials such as Human AB Serum, Human Fibronectin, Human Serum Albumin (HSA), and Human Vitronectin. These materials