Next Generation Nasal Spray Against Influenza
Avir Green Hills Biotechnology (GHB, Vienna, Austria, www.greenhillsbiotech.com) has started the first clinical Phase 1 study for its novel influenza vaccine FLUVACC. FLUVACC is based on the deletion of the NS1 gene.
Avir Green Hills Biotechnology (GHB, Vienna, Austria, www.greenhillsbiotech.com) has started the first clinical Phase 1 study for its novel influenza vaccine FLUVACC. FLUVACC is based on the deletion of the NS1 gene. The first eight volunteers were vaccinated in collaboration with the Medical University Vienna at the General Hospital. The protection rate is expected to surpass the rate achieved with currently available vaccines. FLUVACC is administered as an intranasal spray and differs in its method of production from the currently available flu vaccines. In contrast to conventional influenza vaccines, which are manufactured in chicken eggs, FLUVACC is produced in cultured cells (vero cells). The use of reverse genetics allows quick and efficient fine-tuning to circulating virus strains.
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.
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.
