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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.

• 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.

• 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.

• 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.

• 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.

• Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators

  Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

• 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.

• Tackling Product Quality And Safety Issues Through Global Collaboration

  How the development and execution of a tiered support system, and its results, positively impacted this global collaboration on capacity, efficiency, and cost management.

• Exploring Perfusion Technology For Virus Manufacturing Process Intensification

  Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.

• If You Can't Win The Game, Change It

  Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

• Novel Platform For Execution Of Pragmatic Studies Boosts Cancer Trial Efficiency

  Learn how Flatiron partnered with Genentech and Foundation Medicine to develop a novel platform for the execution of pragmatic studies.

• Analytics–Powered Approach To Patient Recruitment Strategy

  In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.