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WHITE PAPERS AND CASE STUDIES

• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• 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.

• 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.

• How Fine Screens Simplify The New Waste Discharge Requirements

  How are fine screen solutions aiding winemakers in their efforts to meet California State Water Resources Control Board mandates for enhanced monitoring and treatment of winery process water.

• Acoustic Inspection Helps Campbell River Optimize Inspection Program

  In this case study, explore how incorporating the SL-RAT into their maintenance program has realized significant savings for the city of Campbell River.

• From Months To Hours: MMC Medical's EDC Revolution

  Learn how a specialized CRO reduced study build times by 95%. Discover strategies for template reusability and flexible resource scaling to accelerate early-stage medical device validation.

• Case Study: Groundwater DWTP (AK) - DEXSORB Full-Scale

  A DWTP client in Alaska detected elevated PFAS contamination levels in two groundwater wells supplying drinking water to 85 service connections. PFAS concentrations are provided in Table 1, where combined concentration of EPA PFAS6 was detected at 490 to 810 ppt.

• Generation Of Stable CHO Cell Lines For Protein Production

  By following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.

• Why Choose Robotic Processing For Small Batch Aseptic Filling

  Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• A Scalable Single-Use Two-Step pDNA Purification Process

  Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.