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WHITE PAPERS AND CASE STUDIES

• Labware Washing Techniques And The Sinner's Circle

  Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• Preparing CRAs For Success In Oncology: Targeted Training In An Era Of Advanced Therapeutics

  Explore the pivotal role of Clinical Research Associates (CRAs) in oncology clinical trials, emphasizing their critical responsibilities and the importance of specialized CRA training programs.

• 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.

• Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells

  Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.

• Quality By Design: Better Data Using Participant Insights

  While clinical trials will always encounter challenges in driving quality experiences and data, there is one approach that’s backed by regulatory agencies and proven to lead to better outcomes.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• 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.

• Expanding The OSD Toolbox: An Industry Approach To Adsorb Lipids Onto Powder Substrates

  Explore innovative solutions for improving the solubility and bioavailability of poorly soluble compounds in solid oral dosage forms to enhance drug delivery and therapeutic effectiveness.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• 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.