Quality by Design White Papers & Case Studies

  1. 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine

    A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.

  2. Manufacturing Process Scale-Up For Phase III

    The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.

  3. A Case Study In Real-Time Release Testing

    Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.

  4. Quality By Design In Biomanufacturing

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  5. Accelerating Generic Approvals: 5 Keys To Being First To Market

    Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.

  6. MTOSoftgels: Providing Cohort Specific Hand Filled Softgel Capsules For Dose Escalation Studies

    Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall

  7. White Paper: Advancing Regulatory Science For Public Health
    This document outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA, working with partners, to strengthen the field, both within the agency and throughout the Nation. By Food and Drug Administration (FDA)
  8. Case Study: Wyeth Pharmaceuticals, Ireland, Getting Production Down PAT
    The 10th-largest pharmaceutical company in the world, Wyeth Pharmaceuticals, features strongly in the development of innovative products in the pharmaceutical sector and biotechnology. By Siemens Industry, Inc.
  9. Managing Risk And Driving Profitability With Today's Process Analytical Technologies In the Pharmaceutical Industry

    Over the past few decades, terms such as Lean Six Sigma, Total Quality Management, and Continuous Improvement Strategy have become increasingly common in discussions of manufacturing plans.

  10. Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods

    Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software