Government

WHITE PAPERS AND CASE STUDIES

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• 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.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Extra-Terrestrial Connections: Enabling Optical Mesh Networks In Orbit

  Optical filter implementation into orbital mesh networks must consider how price, performance, and delivery timeline can be optimized together to align with specific customer needs.

• Leveraging AI For TMF Classification To Improve Quality, Consistency

  Explore diverse AI methodologies, such as natural language processing and machine learning, elucidating how they seamlessly integrate with current systems to elevate efficiency and uphold quality standards.

• 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.

• Unclogged: Exploring The Evolution Of Grinder Pumps With Axial Cutters

  Explore the V2 Series Grinder campaign, and its advanced features, improved efficiency, durability, and innovation in grinding technology for enhanced industrial and commercial applications.

• Global Resourcing Maximizes PV Operations To Meet Timelines

  Explore how clients were able to leverage the extensive resources of PPD FSP Solutions to maximize their PV operational delivery model and successfully meet ambitious timelines.

• Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

  Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

• Building A Legacy In Sterile Injectables Through Strong CMO Synergy

  Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Enhancing Value In High-Performing Research And Development Teams

  Strategic partnerships are characterized by highly advanced therapeutics and increasingly segmented patient populations. Explore the necessity of multidisciplinary collaboration, from drug discovery to commercialization.