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WHITE PAPERS AND CASE STUDIES

• Process Development For Lyophilized Products

  Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

• Advancements In Microbial Manufacturing Of Biopharmaceuticals

  Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• 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.

• 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.

• 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.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

  This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

• Navigating The Challenges Of Large, International Phase III Breast Cancer Trials

  In the competitive landscape of breast cancer research, aligning biomarker testing, regulatory pathways, and regional operations from day one creates a path to faster enrollment and stronger outcomes.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Drinking Water Disinfection At Lunenberg, Massachusetts, USA Local Community

  In this case study, read how the Lunenburg Water District improved their water disinfection system with the installation of an Atlantium RZ300-11 HOD UV system. The system effectively disinfects water, meets future demands, and eliminates chlorine taste and odor.