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WHITE PAPERS AND CASE STUDIES

• The 5 Ws Of A Human Factors Strategy

  A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

• 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.

• Targeted Indication Selection Using Adaptive Design

  What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• 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.

• 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.

• Ensuring Supply Through Speed And Transparency

  Through speed, transparency, and close collaboration, the pharmaceutical company was able to switch vendors seamlessly, maintaining virtually uninterrupted manufacturing operations.

• Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes

  The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

• Assuring Multipotency Of Human Mesenchymal Stem Cells (hMSCs)

  Stem cell research has revolutionized tissue repair and regenerative medicine. Discover how mesenchymal stem cells play a key role and offer insights into connective tissue repair, immune response, and inflammatory diseases.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

• Pharma R&D Review 2024: Pleasant Weather Ahead

  Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.

• Designing And Evaluating A Water Treatment Media Pilot

  Evaluating the use of activated carbon and other media for water treatment is a crucial step to ensure project goals are achieved.