Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

• A Strategic Guide For Biotech And Biopharma Leaders

  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.

• Cleanroom Recovery. Proven Results. Contamination Control Case Studies

  Through this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• Designing More Representative Trials Through Strategic Planning

  Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.

• 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.

• Navigating The Complexities Of Pre-Filled Syringe Manufacturing

  Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

• NuGenesis 9.3 – What's New

  Explore the latest features of a user-centric lab management system that comprises data, workflow, and sample management capabilities to support the entire product lifecycle.

• 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.

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• Gene Therapy For Mitochondrial Disease: A Guide To Emerging Regulation

  Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.