INSIGHTS ON LIQUID DOSE MANUFACTURING

• Cutting Through Complexity: An Integrated Model For Faster PFS Development

  Discover how integrated, end-to-end development for prefilled syringes can streamline timelines, enhance patient-centric delivery, and scale efficiently from early development to global launch.

• Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing

  This session is designed for teams developing new products, optimizing processes, or preparing regulatory submissions, and will provide practical tools for a better approach to E&L management.

• ASEPTICARE | Multipurpose Aseptic Isolator For GMP Pharmaceutical Processing

  Learn how a multipurpose isolator supports aseptic and aseptic-toxic pharmaceutical processing, from sterile formulation to small-scale filling, with fast decontamination and modular GMP-ready design.

• MIDBA: A New Regulatory Approach To Clinical Device Bridging

  When devices evolve, evidence expectations can shift. Explore a risk-based clinical bridging approach to support regulatory decisions.

• Overview Of Single-Use System Integrity Assurance

  9/24/2026

  Single-use system integrity depends on managing risk across the entire life cycle. Explore how materials, packaging, transport, installation, handling, and use influence sterility assurance.

• Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems

  4/20/2026

  Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.

• Robust, High-Throughput Automated Solution For Water Endotoxin Testing

  4/21/2026

  High-throughput water endotoxin testing doesn’t have to sacrifice consistency. Gain insight into how an automated workflow delivers reliable results, low variability, and strong control recovery.

• Identifying Worst-Case Locations Assessing Homogeneity Using BIs And EIs

  7/27/2026

  Combine quantitative enzyme indicators, computational fluid dynamics, and traditional biological indicators to improve VPHP isolator validation and process confidence.

• The Importance Of Tube Welding In Aseptic Bioprocessing

  3/9/2026

  Sensitive biologics rely on aseptic processing and single‑use systems, making dependable sterile connections essential. See how tube welding offers a reliable way to reduce contamination.