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WHITE PAPERS AND CASE STUDIES

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• 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.

• 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.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• 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.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• Generate High Quality Data And Execute Full Factorial Design Of Experiments

  Learn how a bioprocessing company supplemented their in-house bioreactor capacity and performed large-scale DOE studies using a cloud bioreactor facility.

• 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.

• How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs

  Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.

• Leaks Go Acoustic: How Rogers Water Reduced Waste And Built Resiliency

  Read how Rogers Water Utility (RWU) took action to mitigate constant leaks in their distribution system, which made it challenging to maintain volume in the eastern district’s water tower.

• 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.

• Precision Project Management In Action

  Discover how a tailored, risk-based project management approach was used to overcome the challenges of a complex Phase I/IIa FIH multi-country study of an advanced therapy medicinal product (ATMP).