Case Study from the Journal of Pharmaceutical Science and Technology
The traditional 14-day sterility test for microbial detection leads to longer release times and a lack of data integrity in a manufacturer’s products. Most QC microbiologists understand that innovation is their key to success in operational efficiency and confident data. While they may not know where to start, they do know that they must convince stakeholders of its benefits.
This case study, published in the 2023 PDA Journal of Pharmaceutical Science and Technology, gives an in-depth look at not only the comparisons between several types of rapid microbial detection technologies, but also outlines the steps of the buying journey. Knowing the steps in developing a business case, and how to tackle each hurdle during implementation, brings manufacturers one step closer to meeting their operational and quality goals.
Read real-world experiences from industry thought leaders on how they successfully implemented rapid microbial detections like Celsis® ATP bioluminescence.
Key Takeaways:
- An actionable framework for implementing a rapid microbiological method in your QC lab
- Key decision-making criteria to bring into discussions with stakeholders
- A comparison of ATP-bioluminescence-based and respiration-based sterility platforms based on core and application-specific requirements
Authors:
Sven Deutschmann - Roche Diagnostics GmbH, Penzberg, Germany
Mousumi Paul - Merck & Co., Inc., Kenilworth, NJ, USA
Marja Claassen-Willemse - MSD, Oss, The Netherlands
Jonas van den Berg - Roche Diagnostics GmbH, Mannheim, Germany
Pieta IJzerman-Boon - MSD, Oss, The Netherlands
Viviane Grunert da Fonseca - Roche Diagnostics GmbH, Penzberg, Germany
Ellen Brunbech - Novo Nordisk A/S, Bagsvaerd, Denmark
Lynn Johnson - Takeda, Lexington, MA, USA
Chris Knutsen - Bristol-Myers Squibb, New Brunswick, NJ, USA
Lucile Plourde - Sanofi Pasteur, Marcy-l’Etoile, France
Joanny Salvas - Pfizer, Kirkland, QC, Canada
Philip Villari - Merck & Co., Inc., Kenilworth, NJ, USA
Lisa Wysocki - GlaxoSmithKline, Collegeville, PA, USA
