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WHITE PAPERS AND CASE STUDIES

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials

  Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

  This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

• Building Local Biomanufacturing Capacity In South Africa

  Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

• Exploring Perfusion Technology For Virus Manufacturing Process Intensification

  Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.

• How A Global Pharma Manufacturer Reduced Line Stops And Increased OEE

  Gain insight into how a leading pharmaceutical company identified the root cause of long-standing inefficiencies, optimized performance, and productivity with unprecedented speed and accuracy.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Precision Project Management In Action

  Discover how a tailored, risk-based project management approach was used to overcome the challenges of a complex Phase I/IIa FIH multi-country study of an advanced therapy medicinal product (ATMP).

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Quick Response Following Tropical Storm Prevents Service Disruption

  Following Tropical Storm Isaias, a damaged reservoir outlet pipe needed fast, custom repair. Learn how a quick response, site assessment, and custom-engineered couplings prevented a major water service shutdown.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress