GlaxoSmithKline Gets Positive Opinion on Pandemic Vaccine
Daronrix, GlaxoSmithKline (GSK) Biologicals' (London, UK, www.gsk.com) first-generation, alum-adjuvanted, inactivated, whole-virus candidate flu vaccine for one-time use in a pandemic has received a positive opinion from Europe's Committee for Medicinal Products for Human Use.
Daronrix, GlaxoSmithKline (GSK) Biologicals’ (London, UK, www.gsk.com) first-generation, alum-adjuvanted, inactivated, whole-virus candidate flu vaccine for one-time use in a pandemic has received a positive opinion from Europe’s Committee for Medicinal Products for Human Use. This is a first step in the preparation against a possible H5N1 pandemic.
GSK also announced that it is about to submit a second file to the European regulatory authorities for another vaccine, a second-generation H5N1 candidate vaccine. This vaccine, which is currently in late-stage development, uses GSK’s novel proprietary adjuvant system technology.
The new generation vaccine candidate has the added benefit of requiring a substantially lower amount of antigen to raise a strong immune response, and gives the ability to produce very large quantities of vaccines for mass vaccination. Upon licensure, this second vaccine could potentially be used as part of a proactive pre-pandemic vaccination campaign, helping to prepare the human immune system in advance of a pandemic and give broad protection against different H5N1 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.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
