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WHITE PAPERS AND CASE STUDIES

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• 5 Steps To Design A Microbiological Performance Qualification For Facilities Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
• Biotech Delivers A Superior Patient And Site Experience

  To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

• 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.

• Validating New Identification Algorithms With Objective Criteria & Clinical Trial Data

  Learn how researchers and clinicians can make better-informed decisions to advance patient care and enhance public health outcomes related to myocardial infarction.

• 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.

• 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.

• A Partnership To Deliver Excellence In Antibody Discovery And Production

  Explore the partnership that assisted FairJourney Biologics in methodically handling 30 to 40 different production projects concurrently.

• Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

  A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• A Feeder-Free Platform For Generating Mature Natural Killer Cells

  NK cells represent a promising avenue for immunotherapy. Examine the advantages of NK cells in cellular immunotherapy and the importance of developing efficient activation and expansion platforms.

• Pasteurized Equivalent Water For AgriMark-Cabot Dairy In Vermont

  Discover how AgriMark-Cabot Dairy transformed wastewater into a valuable resource using UV technology, achieving significant energy and water savings while maintaining stringent food safety standards.