Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

• Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer

  Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

• 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.

• Alzheimer's Study Involving Home Infusions Exceeds Expectations

  Gain insight from this Phase 3 global clinical trial focused on pre-clinical Alzheimer’s Disease where adult patients received one-hour intravenous infusions every month for 4.5 years.

• 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.

• 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  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress.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.

• Mobile Lab For A Large Pharma Client

  Completed in 2021, learn how this custom BSL-3 mobile laboratory received PHAC approval and ensured a secure environment for PPD powder-related MTech development work.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• 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.

• 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.

• Solving The Silicone Challenge In Pre-Fillable Syringes

  Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

• 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.