THERMO SCIENTIFIC SOLUTIONS CENTER
Quality by Design: You Cant Manage What You Dont Measure
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Pharmaceutical and biopharmaceutical manufacturers face unprecedented pressures today as they strive to bring safe, cost effective new treatments to market as efficiently as possible. For the past few years, the U.S. Food and Drug Administration (FDA) has been encouraging the industry to take a more scientific approach to drug development and manufacturing. With the mantra of Quality by Design, the Agency has promised regulatory flexibility to those who know their processes and who can control and improve them.
Getting a process right the first time requires a deep understanding of risk, as well as the factors that are critical to product safety and quality, starting at the beginning of the R&D cycle.
Modeling and statistical analysis are essential, but they wont work without data---measurements of critical parameters within the process as it evolves from preclinical to clinical, scaleup and manufacturing stages.
Uniting the broad capabilities of Thermo Electron and Fisher Scientific, Thermo offers capabilities ranging from informatics and bioinformatics tools, to help speed the discovery process, to analytical tools that will help optimize both small molecule and biopharma process development and manufacturing.
Learn more about Thermos diverse products and how they can advance your drug discovery, development and manufacturing efforts.
- PAT in Biopharma Manufacturing by Brian Davies
- PAT and Advanced Control: Bridge the Gap by David Radspinner, Ph.D.
- PAT Solutions Center
White Papers and Articles
- Centrifuge Safety and Security by Tammy Goodman
In this article, Goodman discusses the inherent safety of centrifuges based on new product designs and features.
- HyClone Library
This HyClone resource center provides information on disposable process equipment selection.
- Case History: Automated Screening at AstraZeneca
This case study reveals how Thermo Fisher's Nautilus LIMS was implemented at AstraZeneca to centralize biochemical screening and how it dramatically improved efficiency through superior information management.
About Thermo Fisher Scientific
With more than 30,000 employees around the world, Thermo serves science, and is the largest provider of analytical instruments, equipment, reagents and consumables, software and services for research, analysis discovery and diagnostics. The company prides themselves on four core values: Integrity, Intensity, Innovation, Involvement.
Serving over 350,000 customers in pharmaceutical and biotechnology companies, healthcare and other industries, the company offers products designed to speed time to market and guarantee product safety and quality. Thermo aims to help customers solve analytical challenges from complex R&D issues to routine testing, through a wide range of instrumentation and analytical equipment, software, process equipmment, lab consumables and reagents.
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