Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1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 Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Novartis Acquisition of Regulus Therapeutics is Complete
June 25th 2025A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.
