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|October 15, 2001
- BioPharm International-10-01-2001
- Volume 14
- Issue 10
Statistical Tools for Setting In-Process Acceptance Criteria
by Robert J. Seely, Louis Munyakazi, and John Haury Regulatory approval and successful manufacturing depend on establishing meaningful and reasonable acceptance criteria for process validations and ongoing monitoring. Three methods are presented here to correct for the likely underestimation of process limits due to small samples.
Advertisement
Articles in this issue
almost 25 years ago
Qualification of Network Components and Validation of Networked Systemsalmost 25 years ago
Managing Your Career: Recruiter-Proof Your Organizationalmost 25 years ago
Inside Washington: Crisis and Costs Grip Biotech Industryalmost 25 years ago
Outsourcing OutlookAdvertisement
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