INSIGHTS ON QUALITY CONTROL

• Material Transfer Into A Cleanroom: How To Reduce Contamination Risk At Every Step

  Evaluate packaging integrity and master wiping techniques to prevent cleanroom contamination. Focus on surface coverage and controlled transfer paths to ensure consistent product safety and quality.

• Leveraging A Modern HPLC System For Peptide Drug Substances Analysis

  This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

• Esco IntelliGlove Tester (EIGT)

  Ensure sterility with wireless glove leak testing. Align with Annex 1 and ISO standards through portable, traceable, and cable-free integrity checks that optimize cleanroom safety and workflows.

• Quantifying Endotoxins Via Absorbance Or Fluorescence

  Find out how endotoxin assays use Factor C activation to generate measurable absorbance or fluorescence signals, with guidance on selecting detection formats and implementing scalable workflows.

• Detection And Quantification Of Amorphous Content In Materials

  12/30/2024

  Complementary analytical techniques like DSC, MDSC, cRHp, DVS, and SolCal accurately quantify amorphous content in pharmaceuticals to ensure stability, compatibility, and efficiency.

• Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

  12/9/2024

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

• 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.

• The Role Of Quality By Design In Pharmaceutical Tablet Development

  7/30/2024

  Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.

• The Pain Of Change – Could Suppliers Be Part Of The Cure?

  10/15/2024

  Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.