Healthcare

WHITE PAPERS AND CASE STUDIES

• Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility

  Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Automated Evidence Generation For Regulatory-Grade RWD

  Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

• Unveiling The Critical Role of Sleep In Clinical Studies

  Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.

• Preparing The Next Generation Of Clinical Research Professionals

  Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.

• Innovation In Filtration

  Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

• Oligonucleotide Synthesis: Scale-Up Made Simple

  Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

• Rewriting The Future Of Clinical Trials

  In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development

• How A Pharma Company Improved Yield By 1.5% In Just Three Months

  A pharma company faced a 4% yield drop and variability at a manufacturing facility. Explore how they leveraged an AI-based platform to unify data, pinpoint inefficiencies, and enhance consistency in yields.

• Machine Learning In Intelligent Power Management Systems

  Machine learning for MCU implementation (Tiny ML) is transforming battery management and motor control by utilizing machine learning algorithms to analyze sensor data, optimizing performance and assessing system health.

• 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.