Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
The purpose of this guidance document is to inform all establishments engaged in the manufacture of Source Plasma that FDA, has approved nucleic acid tests (NAT) to identify human immundeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in Source Plasma donations; 2) that it believes that a licensed nucleic acid test to identify HIV and HCV in Source Plasma donations, when available, should be used to adequately and appropriately reduce the risk of transmission of these communicable diseases; and 3) that it expects that a licensed nucleic acid test to identify HIV-1 and HCV in Source Plasma donations will be available after establishments submit biological license application (BLA) supplements providing for the use of an approved nucleic acid test, and after we have approved such supplements.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
