Real-world data show weight loss after switching to the Wegovy pill, Lilly reports positive hand and foot atopic dermatitis data, and Teva wins FDA approval for a Xgeva biosimilar.
|Podcasts|April 16, 2021
Data Integrity and Digital Workflow Guidance for the Contemporary Pharma Lab
Author(s)Sartorius
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.
Related to this article
In the OCTANE real-world analysis presented at EASD 2026, adults who switched from injectable semaglutide or tirzepatide to once-daily oral semaglutide lost an average of 4.1% of body weight after 3 months.
Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.
More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.
Sponsored
Meeta Gulyani, Ecolab Life Sciences, shares where biomanufacturing is headed next and why the relationship between drug developers and their suppliers is changing along with it.
Novo Nordisk licenses a once-weekly oral GLP-1/GIP candidate, uniQure reports 48-month Huntington’s disease data, and AstraZeneca invests $2 billion in Summit Therapeutics.
Novo gains global rights, excluding Greater China, to HRS-1596, a phase 1-ready GLP-1/GIP dual receptor agonist that Hengrui says has potential for once-weekly oral dosing in obesity and type 2 diabetes.
NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.