INSIGHTS ON LIQUID DOSE MANUFACTURING

• Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process

  Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.

• Explore A High-Performing Basal Medium And Feed Pairing

  A customer sought to replace a chemically defined CHO medium with a more efficient medium and feed pairing strategy in bioreactors.

• Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing

  Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

• Safeguarding Biologic Integrity Through Enhanced Component Compatibility

  For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

• A Standardized Gloveless Robotic Isolator

  10/16/2024

  By eliminating human intervention—the primary risk factor compromising drug sterility and quality—gloveless aseptic processing technology offers manufacturers greater flexibility, safety, and regulatory compliance in their filling operations.

• A Risk-Based Decision Framework For Selecting Aseptic Barrier Technologies

  3/20/2026

  EU GMP Annex 1 requires a risk-based approach to selecting Isolators or RABS. This framework evaluates human intervention and decontamination to ensure robust sterility assurance.

• Practical USP <1665>/<665> Guide To E&L Risk Assessment

  2/17/2026

  A practical USP <1665> and <665> framework helps manufacturers evaluate and manage extractables and leachables risk, supporting quality, safety, and regulatory compliance.

• The Successful Implementation Of A New Aseptic Filling Line

  10/10/2024

  Discover how a Quality by Design approach can streamline the development of new sterile product filling lines, featuring a real-life example illustrating its effectiveness.

• Navigating Your Holistic Approach To CCI For Biologic Drug Products

  6/12/2024

  Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.