INSIGHTS ON QUALITY CONTROL

• Ensuring Performance And Compliance: Successful FAT Of Filling Line Isolator For Creative Lifesciences, Taiwan

  Rigorous Factory Acceptance Testing ensures filling line isolators meet performance and safety standards. This validation is vital for aseptic integrity and protecting both product and operator.

• 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.

• Organ-Chips Outperform Animal Models And Spheroids

  Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.

• 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.

• Contamination Control Strategy: Compressed Gas Monitoring Of Microbes

  3/3/2026

  Microbial survival during gas decompression is a proven risk. Learn why point-of-use monitoring is essential for Annex 1 compliance and how to ensure process gas purity in sterile environments.

• Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy

  2/6/2026

  The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.

• Building A Connected Quality And Manufacturing Ecosystem In Life Sciences

  12/27/2024

  Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

• HPLC Autosampler Performance I: Challenging USP Methods

  9/16/2024

  In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.

• Lentiviral Vector Upstream Process

  12/12/2025

  Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.