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WHITE PAPERS AND CASE STUDIES

• Converting iPSC To T Cells: Key Challenges And Considerations

  Explore how by addressing challenges in differentiation, clone selection, and manufacturing, iPSC-based T cell therapies could revolutionize cancer treatment and other diseases.

• The Savings Are Blowin' In At Port Washington Wastewater Treatment Plant

  The municipal wastewater treatment plant in Port Washington, Wisconsin, is located on the picturesque shore of Lake Michigan, so it’s essential that their plant performs as designed.

• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

• 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.

• Leveraging Integrated Electronic Laboratory Notebook And Inventory Systems

  Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development.

• 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

• 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 Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• 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.

• 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.

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.