Maintenance / Service

WHITE PAPERS AND CASE STUDIES

• Maintaining Quality And Regulatory Compliance To Support Rapid Global Growth

  Discover how Huvepharma, a global pharmaceutical company, implemented software to standardize quality management processes across its manufacturing sites, enhancing compliance and efficiency.

• Media Exchange In iPSC Cell Expansion And Differentiation: A Comparative Study

  Low-shear, closed-system media exchange in iPSC differentiation is vital for scalability. This study compares automated centrifugation to gravity sedimentation, showing equivalent or superior differentiation outcomes.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• Inline Checkweighing Of Packaged Products In Manufacturing

  Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

• Implementing A Next-Gen MES At A Fraction Of The Cost

  Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

• Contamination In The Shadows: Risks Lurking From Environmental Issues

  Discover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• Streamlining Antibody Capture With Multi-Column Chromatography

  Explore innovative solutions to overcome the limitations of traditional batch chromatography, improving efficiency, reducing costs, and optimizing production for complex biologics like monoclonal antibodies.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• Illumina Fortifies Supplier Relationship With Digitalization

  Illumina improved its quality management by adopting digitalization, enhancing supplier collaboration and efficiency in monitoring, while transitioning from rigid manual processes to a streamlined, integrated system.

• 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.

• 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.