Newsletter | February 27, 2025

02.27.25 -- A New Approach For Minimizing Human Errors In Biopharmaceuticals

FEATURED EDITORIAL

Computer Systems Validation Pitfalls, Part 4: Inattention To Details

The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

Top 10 Data Auditor Statistical Software Requests

Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.

A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

INDUSTRY INSIGHTS

Adapting Single-Use Chromatography To Manufacturing Scale

Gain insights into strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.

NEWS HEADLINES

FDA Approves First Rapid-Acting Insulin Biosimilar Product For Treatment Of Diabetes

Samsung Bioepis Gains European Commission (EC) Approval For Denosumab Biosimilar (OBODENCE, XBRYK)

FDA Approves Samsung Bioepis' OSPOMYV, XBRYK (denosumab-dssb), A Biosimilar To Prolia And Xgeva

Celltrion Expands Biosimilar Portfolio In The European Union Following European Commission Approval Of Two Biosimilars

Alvotech And Teva Announce Filing Acceptance Of U.S. Biologics License Application For AVT06, A Proposed Biosimilar To Eylea (aflibercept)

SOLUTIONS

An NGS-Based Platform To Streamline Genetic Stability Testing