Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 3 Ways To Address Sterility Assurance Requirements Of The EU GMP Annex 1

  Learn about the three key proactive steps companies need to take to meet the sterility assurance requirements of the EU GMP Annex 1 for the manufacture of sterile medicinal products.

• On-Demand Payment Technology Offers Accuracy, Speed, & Transparency

  Review current grant payment practices and how new software tools can transform the process, efficiently solving the problem that first gave rise to sponsor-funded escrow accounts.

• 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.

• Performance Dashboards Development

  Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.

• Optimal Syringe Carton Design To Meet Drug Manufacturers' Needs

  Learn about the advantages of an optimal packaging design and the resulting benefits of its implementation to the overall process.

• Controlling Trace Impurities In Chemically Defined Media

  Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

• Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing

  An integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.

• Accelerated Peptide Drug Development And Clinical Strategies

  Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

• 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.

• 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.

• Navigating The Translation To Clinic: Future-Proof Your Plasmid Products

  Future-proofing products with strategies that reduce risk and timelines for later stages can be resource-intensive but add significant value. Explore the challenges encountered progressing from development to clinic.