Quality by Design White Papers & Case Studies

  1. Manufacturing Process Scale-up For Phase III

    Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?

  2. 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.

  3. Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry

    As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

  4. Pharmaceutical Manufacturing: The Challenge Of Setting Effective Product Specifications

    Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments

  5. 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.

  6. 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.

  7. 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

  8. 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)
  9. 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.
  10. 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.