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WHITE PAPERS AND CASE STUDIES

• 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.

• Dechlorination For Disinfectant Wipes Manufacturer

  Nice Pak/PDI, a disinfectant wipes manufacturer, chose Atlantium's HOD UV solution for dechlorination due to its cost-effectiveness and alignment with their chemical-free production goals. The solution effectively removes chlorine and reduces biofouling potential, providing double protection.

• Choosing The Right Tech To Optimize Processes And Reduce Costs For Therapeutic Proteins

  Discover how scalable and cost-effective manufacturing solutions can optimize your biopharmaceutical production, ensuring the successful commercialization of your therapeutic protein and broader patient access.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• 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.

• Custom Mobile Pharmacy Cleanroom Trailer For Oncology Infusion Pharmacy Services

  Gain insight into the mobile cleanroom that was created to accommodate the needs of Moffitt Cancer Center's Oncology Infusion Pharmacy Services and adhere to USP <797> and <800> standards.

• 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.

• Simplifying The Transition To Multi-Column Chromatography

  Explore the advantages of multi-column chromatography and how to transfer your process from batch to an intensified system, step-by-step.

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• 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.

• Key West Resort Utilities Maximizes Reuse And Nutrient Recovery

  Water scarcity poses unique challenges to KW Resort Utilities Corp. (KWRU), the utility firm that provides wastewater management, wastewater recovery, and wastewater treatment in the region. KWRU began operation in the late 1960s and has worked hard over the decades to keep up with wastewater needs as population and tourism have boomed, spurred by land reclamation and development. 

• Low-SWaP SWIR ALPD Product Development At SUI

  Sensors Unlimited Inc. advances SWIR imaging with cost-effective, uncooled ALPD technology, enhancing multi-mode tracking, increasing detection range, and improving manufacturability for high-volume military and commercial applications.