Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline

  Go inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.

• Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids

  Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.

• Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process

  Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.

• How Adaptive Design Accelerates Early‑Phase NSCLC Development

  Adaptive trial designs and an adaptive mindset enable non-small cell lung cancer (NSCLC) sponsors to optimize dose, respond to evolving expectations, and accelerate early‑phase development.

• 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.

• Quantitation Of Monoclonal Antibodies In Serum

  Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

• 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. 

• Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance

  Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.

• Incorrect Clinical Trial Enrollment Is Preventable. A Tale Of Three Case Studies

  See how three clinical trials used centralized eligibility review to accelerate enrollment, eliminate enrollment-based protocol deviations, and keep studies on track, even at a global scale.

• How A Global Biosimilars Company Cut Manual Data Errors By 50%

  Learn how a global biopharmaceutical leader halved transcription errors and integrated over 350 instruments to accelerate the development of high-quality, clinically proven biosimilars.

• Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies

  Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.

• The Digital Transformation Of A Leading CDMO's Process Development Lab

  Discover how a leading CDMO was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.