INSIGHTS ON QUALITY CONTROL

• Predicting Softgel Stability And Shelf Life Using Accelerated Modeling

  Predict ibuprofen softgel shelf life in 21 days instead of years. ASAPprime modeling identified PEG-ester degradants as the limiting factor, estimating 5.5-year and 3.8-year shelf lives before long-term studies concluded.

• CMC (Chemistry, Manufacturing and Controls) Management

  Eliminate regulatory risks caused by fragmented data. Learn how a continuous data thread from bench to batch streamlines tech transfer and accelerates filing timelines.

• Ask Us Anything: Mark Benger On Solid-State Strategies For Drug Development

  Mark Benger, Site Director at Cambrex Edinburgh, on solid-state characterization as an insurance policy — front-loaded work that quietly determines whether a program survives the jump from kilos to tonnes.

• Manufacturing Readiness: Why Compliance Is Won Or Lost On The Floor

  Achieve continuous regulatory readiness by embedding ALCOA++ compliance directly into manufacturing workflows to eliminate paper-based documentation risks.

• Trend Analysis Of Particle Monitoring Data And Defining Alert And Action Limits

  9/9/2026

  Routine trend analysis of total and viable particle monitoring data helps identify operational shifts early, set statistical limits, and strengthen cleanroom contamination control strategies.

• Factory Acceptance Testing (FAT): Pre-Shipment Quality Verification Guide

  7/6/2026

  Quality control begins long before installation. Discover how pre-shipment testing mitigates risk, ensures specification compliance, and streamlines cleanroom project timelines.

• How To Achieve Right-First-Time Manufacturing

  1/21/2026

  Modernizing QC requires more than isolated fixes. Discover how cloud-based platforms unify systems, automate workflows, and improve data access to help labs reduce cycle times and minimize rework.

• 0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?

  2/19/2026

  Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

• Cloud Migration In Regulated Environments: Validation Implications And Best Practices

  3/27/2026

  Cloud adoption is essential for BioPharma growth, offering scalable tools for faster research. Success requires a risk-based approach to ensure data integrity and GxP compliance during the shift.