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WHITE PAPERS AND CASE STUDIES

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• 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.

• 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.

• Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials

  Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.

• 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.

• 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.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Advancing Drug Development With Optimized LC-MS/MS Bioanalysis

  Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.

• How eSource Reduced Benchmark's Protocol Deviations By Almost 40%

  Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.

• A Powerful Non-Destructive Tool For Tablet Characterization

  Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

• Multiple Fill Line Delivery Experience

  Learn how a multinational pharmaceutical company successfully implemented a global strategy for insulin cartridge filling, achieving seamless regulatory approval with zero deviations.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.