Virus Inactivation in the 1990s ? and into the 21st Century Part 3a, Plasma and Plasma Products (Heat and Solvent/Detergent Treatments)
by Gail Sofer, BioReliance Plasma products have been associated with high levels of risk from viral contamination; therefore, most viral inactivation methods described in the literature during the past ten years have addressed plasma and plasma products. Plasma is the largest group to cover, and Part 3 takes two articles in our series to describe the many methods published. This article covers heat and solvent/detergent inactivation treatments for plasma.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
