Business Process Management

WHITE PAPERS AND CASE STUDIES

• Automated Validation And Centralized Data

  Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• How Lipid Nanoparticles Enable Next-Gen Delivery

  Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

• Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide

  Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.

• 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.

• 2026 State Of Clinical Trial Technology: The Five Strategic Imperatives

  AI acceleration and digital fragmentation are reshaping clinical trials. Discover five imperatives driving interoperability, smarter site enablement, and data‑ready workflows for future‑ready operations.

• OPTICHECK Technology Built-In – Diagnostics, Verification, And Functional Safety With OPTIMASS Coriolis Mass Flow Meters

  State-of-the-art measuring devices such as OPTIMASS Coriolis mass flow meters combine robust measuring principles and powerful electronics to produce a wide range of readings and device-specific data. OPTICHECK technology built-in leverages the features of the devices to translate their available comprehensive measuring system data into sophisticated diagnostics information for plant personnel. 

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• The City Of Fayetteville's Flood Resiliency In The Face Of Climate Change: Mapping 15 Watersheds

  The city of Fayetteville, North Carolina has always had flooding issues, but it’s been getting worse as weather patterns have been changing. They were hit four years in a row by storms Matthew (2016), Irma (2017), Florence (2018), and Dorian (2019). 

• Elevating Downstream Process Development With Real-Time Data Monitoring

  Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

• Getting Started With Product Development Strategies

  Simplify and streamline new product development for success. Explore the importance of new product innovation, different process methods, and best practices for optimizing your company’s strengths.

• 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.