Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing

  Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.

• 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.

• Inspecting On The Edge — Understanding Punch Tip Wear

  Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?

• Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments

  During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.

• Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour

  A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.

• Fortrea Optimizes Site Matching On Retina Clinical Trials

  Faced with challenges in engaging clinical trial sites within the retina research landscape, Fortrea sought a partnership that leverages RWD to streamline site feasibility assessments.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Improving Patient Health And Safety: Medical Safety Scientist

  See how this experienced safety scientist managed benefit-risk assessments and pharmacovigilance while streamlining product development and lifecycle management for a pharmaceutical company.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• 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.

• Navigating Digital Transformation For Pharmaceutical CDMOs

  Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.