Business Process Management

WHITE PAPERS AND CASE STUDIES

• Global e-Consent Matrix

  Navigate complex regional regulations and identity requirements to modernize your global clinical trial enrollment. Ensure compliance and access while moving toward digital participant engagement.

• 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.

• Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

  Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

• Open-Label Study Assessing Relative And Absolute Bioavailability

  Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

• Small Volume ATMP Cryo-Freezing Strategies

  Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.

• Unravelling The Complexities Of ADC Manufacturing

  Whether you're in the early stages of development or scaling up for commercialization, understanding ADC manufacturing challenges is essential for bringing life-saving therapies to patients worldwide.

• Why Choose Robotic Processing For Small Batch Aseptic Filling

  Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.

• How A Strategic Partnership Drove Micro Molding Success

  In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling production program into a 150-million-part success through trust, scalability, and true strategic partnership.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• Comparing Process Development Approaches For Recombinant Proteins

  Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.

• Office Of Naval Research Contract Leads To New Chlorine Sensor Technology

  Developed from U.S. Office of Naval Research requirements, this multiparameter chlorine sensor offers extended maintenance-free operation, flow-independence, and automatic compensation for reliable, in-pipe monitoring.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.