CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.
|Articles|April 15, 2003
- BioPharm International-04-01-2003
- Volume 16
- Issue 4
Virus Inactivation in the 1990s and into the 21st Century
by Gail Sofer, BioReliance Dorothy C. Lister, and Jeri Ann Boose Smallest of the microorganisms, viruses depend on other cells ? like those used by biopharmaceutical manufacturers ? for reproduction. And viruses and drug products are idiosyncratic: Both the inactivation process and the product strongly influence the successful outcome. In this conclusion to the virus inactivation series, model ivruses are used to represent single- and double-stranded DNA and RNA viruses, to enable you to reach conclusions about effective inactivation methods for a range of viruses.
Advertisement
Articles in this issue
over 23 years ago
Getting Ready for Risk-Based GMPsover 23 years ago
GMP Issues: Breaking Groundover 23 years ago
Guest Editorial: Benchmarking Biotechover 23 years ago
Optimized Nutrient Additives for Fed-Batch Culturesover 23 years ago
Inside Washington: GMP Progress ReportAdvertisement
Related to this article
LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.
Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.
Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.
The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.
A planned phase 3 trial will test the TROP2 ADC and PD-1/VEGF bispecific together in 1st-line triple-negative breast cancer.
Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.
Advertisement
Advertisement