INSIGHTS ON QUALITY 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.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• 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.

• Compressed Gas Risk Assessment: A Significant Step In Your CCS

  Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

• 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.

• A Closer Look At Multi-Lane Checkweighing In Pharma

  5/2/2025

  Learn how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets and nutraceutical products.

• Automation-Assisted Washing Of Multicellular 3D Spheroids

  11/7/2025

  Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.

• 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.

• Host Cell Impurities, Bioassays, Micro-Flow Imaging

  4/9/2024

  Ensuring the safety and efficacy of cutting-edge biopharmaceuticals hinges on meticulous quality control measures. Explore the role of qPCR and MFI in safeguarding drugs from potential contamination.