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WHITE PAPERS AND CASE STUDIES

• Manufacturing Strategies To Industrialize Autologous Therapies

  Discover how a systematic approach to autologous cell therapy manufacturing can reduce costs, improve reliability, and accelerate access to life-changing treatments.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• 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.

• ADC Development Grows More Complex — SPR Insights Bring Clarity

  Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• 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.

• 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.

• Tracking Functional Capacity To Advance Neuromuscular Disease Research

  This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.

• 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.

• Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration

  Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.