Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 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.

• AOC GMP Manufacture For A FIH Study

  Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.

• Increasing Batch Size And Reducing Cycle Times For A Biologic

  JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• Newport News, VA Deploys 130,000 Mueller AMI Meters

  Eight years ago, Newport News started having discussions about moving away from reading their mechanical, manually read meters every other month to go to monthly billing. Knowing they did not have adequate staffing to handle that task, the department decided to outsource its meter reading responsibilities to a third party. 

• Accelerating SARS-CoV-2 Immunotherapy Speed To Clinic

  A clinical-stage biotherapeutics company developing a COVID-19 immunotherapy searched for a solution to the difficulties it faced in scaling up its manufacturing operations due to limited resources.

• Pioneering The End-To-End Decentralized Trial Experience

  This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• 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. 

• Authentic Engagement: Reaching Underserved Lupus Patients

  By partnering with the ICLF, see how we were able to gain access to and build trust with influential community leaders and advocates within the African American communities located near study sites.

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.