INSIGHTS ON QUALITY CONTROL

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

  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.

• Understanding cGMPs For Phase 1 Investigational Drugs

  Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

• Aseptic Expertise And Delivery Of Services

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

• Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

  Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

• Strategic CMC Planning Through A Phase-Appropriate Quality Approach

  5/28/2024

  A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.

• A Powerful Non-Destructive Tool For Tablet Characterization

  10/6/2025

  Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

• Leachables Method Development, Validation And Relevant ICH References

  5/16/2025

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO

  5/14/2025

  Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.

• How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows

  2/3/2025

  The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.