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WHITE PAPERS AND CASE STUDIES

• Nasal Vaccine Development, Manufacturing, And Device Selection

  When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• Optimizing Poloxamer 188

  Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

• Patient Insights Informed Consent Engagement

  By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Pharma Custom Isolator For Sterile Lab Process

  This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.

• RO Protection At Trimble County Power Station, US

  Read about how the installation of the HOD UV technology has been a viable non-chemical means for biological control and membrane protection for Trimble County.

• Full Scale Operations For Parenteral Pharmaceuticals

  Explore how a project team accelerated through milestones in development, approval and execution of Equipment Evaluations, Equipment Specification Documents, Installation Qualification, and Operational Qualifications.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization

  There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

• Navigating The European Market's Regulatory Complexities

  Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.

• Industrial Smart Components: What To Use When

  The objective of this paper is to provide an overview of the current standard industrial HID Global RFID tag portfolio and provide a guideline of the RFID tag family’s main propositions.