Correct data is fundamental in a GxP quality system. This podcast will discuss what needs to be put in place to achieve data integrity and minimize the risk for an organization. We will discuss how to achieve data integrity and give real examples from FDA warning letters about the most frequent violations. To prevent violations, processes and systems should be designed to follow the ALCOA principles which will be explained in detail. We will review how a modern lab instrument can provide all the technical features which are needed to automate processes, ensuring that data integrity compliance issues are not created. As an example, we will present the functionalities of Cubis II, the 2nd generation premium laboratory balance from Sartorius. We will also discuss software applications for QC- or production-relevant applications like Tablet & Vial checker (Uniformity of dosage, USP chapter <905>), Loss on Drying (USP Chapter <731>), Standard preparation (USP Chapter <129>), Pharma Filling (Transfer of liquid products) or MYCAP CCX (Transfer of media and inoculum). The software applications safely guide operators through the workflow, automatically calculate the results and have conformity checks included.
ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
Beam’s base-edited cell therapy met its primary endpoint in the BEACON trial, and a U.S. biologics license application is planned as early as year-end.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
