Newsletter | September 5, 2025

09.05.25 -- Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities

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Webinar: Scientific Insights into Vaporized Hydrogen Peroxide (VHP) Biodecontamination and Managing BI Quality Variances

This Körber webinar explores best practices for biodecontamination in pharmaceutical manufacturing, emphasizing Quality Risk Management and compliance with the revised EU GMP Annex 1. Topics include comparing VHP vs. dry fog, managing Biological Indicator (BI) quality—especially Rogue BIs—applications in barrier technology and material transfer, optimizing cycle efficiency, ensuring biocompatibility with biological products, and strategies for reliable, compliant process validation. Click here to learn more.

INDUSTRY INSIGHTS

Ensuring Tablet Logo Legibility: A Critical Step In Preventing Medication Errors

Tablet debossing aids medication identification and must meet FDA standards. Font, scale, color, shadow, and stroke details are key for optimal legibility and safety.

The Roadmap To Asset Performance Management In Life Sciences

Find out how asset performance management boosts reliability, compliance, and efficiency in life sciences, which guides organizations from reactive fixes to predictive optimization.

FEATURED EDITORIAL

Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities

In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

INDUSTRY INSIGHTS CONTINUED

Human Factors Testing: Engaging End-Users In Med Device Development

Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

Advancing QC Efficiency With SEC-MALS System And Empower Software

Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.

Why Fill-Finish Strategy Can Make Or Break Your Drug Program

Sterile injectable success depends on early CDMO partnerships. The right fill-finish partner ensures regulatory compliance and scalability, transforming development challenges into commercial success.

CLD To Upstream Optimization: Enhancing Biologics Quality, Productivity

Watch how advanced cell line development and upstream processing strategies optimize both productivity and therapeutic effectiveness, ensuring the development of high-quality biologics.

Influence Of Peptones On CHO Glycosylation Profiles

This study explores the impact of nutrient availability and complexity on the glycosylation profiles of monoclonal antibodies (mAb) produced by different CHO cell lines.

Performance Dashboards Development

Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.

Strategy Planning And Execution For Facility Compliance

A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

Still Pipette-Filling Cryovials? There's A Better Way

Manual cryovial filling in cell therapy is risky, time-consuming, and unsustainable. See why automating this crucial step is essential for precision, viability, and scalability.

Optimized Stability Storage

A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to another company, resulting in reduced costs and focus on core competencies.

SOLUTIONS

3-Bucket Mopping System - Correct Mopping Protocol

Take Action Faster: Gain Control Over Your Critical Processes

Polymer Processing Capabilities

Bio-Expo Live February 2025: Quality, Data, And Analytical Solutions

Validation Doesn't Need To Bleed Time Or Money

The Future Of QC: Robotics And Automation

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