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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.

• Achieving Self Sufficiency In Data Collection For Optinose

  Uncover how this specialty pharmaceutical company was able to gain control over its EDC environment by adopting a solution their team could use in-house.

• 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.

• Patient Insights Informed Consent Engagement

  By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.

• The State Of Global Clinical Trial Disclosure

  See what industry organizations are saying about trial transparency, regulations by region, what penalties are on the books, and whether they are enforced.

• How GIS Improved Workflows For The Largest Municipal Utility In The U.S.

  Read how LADWP updated its workflows and enriched its management of data by implementing a new enterprise-wide GIS platform, based on Esri’s ArcGIS Enterprise, as well as several apps.

• 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.

• Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

  Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

• The Burden Of MES Vendor Cloud Migration In Drug Manufacturing

  Uncover the challenges and limitations of on-premise MES vendor cloud migration, and explore the modern, cloud-based solutions that can circumvent them.

• The State Of Plastics Recycling In BioPharma

  Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.

• The Importance Of Understanding Materials In Medical Product Development

  Explore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.