High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• 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.

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

• Anaerobic Digestion Optimization System Provides Exceptional Improvements

  Faced with soaring ammonia loads—especially during race weekends when 250,000+ fans descend on the town—the Speedway, Indiana Wastewater Treatment Plant was in urgent need of a solution.

• Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine

  Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

• Medical Device Manufacturer Implements A Next-Gen MES

  A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.

• Soil Testing: From Filtration To Fertilizer To Food

  Soil analysis offers a clear view of the factors that influence land productivity while helping identify contaminants that could threaten safety. Understand the indicators to support sustainability decisions.

• Converting iPSC To T Cells: Key Challenges And Considerations

  Explore how by addressing challenges in differentiation, clone selection, and manufacturing, iPSC-based T cell therapies could revolutionize cancer treatment and other diseases.

• 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.

• Extractables And Leachables Assessment For Single-Use Systems

  Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Breaking Down Operational And Financial Complexity In Clinical Trials

  Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.