Quality by Design White Papers & Case Studies

1. Characterization Of Protective Face Masks 10/7/2020

   Face masks, such as surgical masks, are intended to prevent large particles from being expelled by the wearer into the environment. This report focuses on the physical characterization of a three-layer pleated mask and a molded cup mask.

2. 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine 12/26/2018

   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.

3. Manufacturing Process Scale-Up For Phase III 8/15/2017

   Explore factors that pharmaceutical companies of all sizes and experience levels must consider to ensure their formulations are successful during larger-scale manufacturing.

4. A Case Study In Real-Time Release Testing 7/11/2017

   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.

5. Quality By Design In Biomanufacturing 12/22/2011

   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 12/12/2011

   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 11/2/2011

   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 12/9/2010
   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 2/28/2010
   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. 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