Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Reducing Risk And Timelines In Cell Line Development

  Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

• Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech

  This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.

• Thales Receives Custom 10PW Beam Dump For World's Most Powerful Laser

  By collaborating with Gentec-EO and their distributor Laser Components, see how Thales was able to gather the necessary specifications and requirements for this project.

• Overcoming Known Pharmacological Effects

  Uncover how our team was able to address the challenges of evaluating treatments that reduce food consumption and cause body weight loss while ensuring animal health and study integrity.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• Removing Translation Bottlenecks With AI

  See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.

• 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.

• Stopper Migration In Frozen Pre-Filled Syringes

  Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Forge Boosts Efficiency And Compliance During External Collaboration

  Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

• 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.