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WHITE PAPERS AND CASE STUDIES

• Orthogonal Methods To Understand And Define CQAs Of AAV Therapies

  An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

• Site Satisfaction: Influencing Tech Development Strategies

  Technology is playing an increasingly important role in clinical trials, helping to improve efficiency, compliance, and data quality. Learn why it’s critical that clinical study technologies are easy to use across sites and fit into the team’s workflows.

• Improve Your Molecular Cloning Process With Synthetic Biology Automation

  Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.

• Leveraging The Bolar Exemption To Accelerate Market Access

  Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

• Full Scale Operations For Parenteral Pharmaceuticals

  Explore how a project team accelerated through milestones in development, approval and execution of Equipment Evaluations, Equipment Specification Documents, Installation Qualification, and Operational Qualifications.

• Solving The EHR-To-EDC Challenge: A Scalable-First Approach

  Unearth how industry shifts, technology adoption, and interoperability openness are paving the way for scalable solutions.

• Metastatic Breast Cancer Rates Show Disparities Between Black And White Patients

  Given that age and screening have observable but not fully explicable effects on risk, a new analysis investigates the racial disparities in breast cancer outcomes.

• 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.

• BMS Adopts A New Clinical Data Architecture

  Learn how Bristol Myers Squibb was able to optimize data review processes to streamline and improve access to clinical trial records.

• Establishing Analytical Methods For mRNA-Based Therapies

  Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

• 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.

• Revolutionizing Lead Service Line Removal: A Milestone For Detroit's Water Infrastructure

  Detroit, like many other cities across the U.S., has grappled with a silent threat lurking within its aging water infrastructure: lead service lines. Learn why The Detroit Water and Sewage Department partnered with BlueConduit to help make the lead service line inventory and removal process more efficient than ever before.