Centivax, a developer of broad-spectrum vaccines, announced on Tuesday that it has partnered with Emery Pharma, a California-based contract research organisation specialising in GLP/CGMP compliant solutions for analytical testing, bioanalytical testing and microbiology.
This partnership leverages Emery Pharma's expertise to develop an IND-enabling GLP compliant potency release assay for GMP batches of the Centivax pan-influenza universal vaccine clinical candidate, Centi-Flu.
Emery Pharma will establish a mass-spectrometry based comprehensive Centi-Flu expression and in-vitro potency assay, which will serve as the definitive batch release assay necessary for validating manufactured vaccine doses for use in the clinic and post-approval commercial doses. According to Centivax, Emery Pharma's expertise enables an unparalleled quantitative resolution to ensure that manufactured batches of Centi-Flu are released with uniform potency and quality for all components. The partnership further establishes a compatible process for potency batch release assays further enabling follow-on universal vaccines from the Centivax antibody and T-cell epitope focusing platform.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA