Search results for "qbd"
Webcast
Accelerating time to market through process innovation
Wed, Jun 14, 2023 8:00 AM - 10:30 AM EDT
The journey from molecule discovery to manufacturing can be challenging and market success is heavily dependent on the swift creation of high-performing…
Article
How to program, run and evaluate a design of experiments (DoE)
In this free, interactive course, Dr. Martin Sichting, Product Manager Lab Scale Chromatography Systems at Cytiva, guides you through the DoE process.
You’ll learn how to program, run, and e…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
Statistical models based on QbD sometimes fail. When you set up a statistical model based on DoE, you don’t really know if you have all the right parameters in play and whether or not you’ve taken eve…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Prior to QbD, pharmaceutical development did not require the establishment of functional relationships between CPPs and CQAs. Consequently, process characterization experiments were primarily univaria…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
The best solution to managing risk factors is to use quality by design (QbD) to classify them, applying tools such as Ishikawa fishbone diagrams or failure mode and effects analysis (FMEA), agrees Luc…