Search results for "quality by design" in Articles / App Notes
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
By Feliza Mirasol
…
Article
e-Learning: what is quality by design (QbD)?
This free interactive course shares what quality by design (QbD) is all about. The focus lies on applying QbD to process development of biopharmaceuticals.
Key learnings:
- Fundamen…
Article
Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …
Article
Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
Click here to download the white paper now >>
The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
Article
Designing a 1.5 L Bench-Scale Model of a Perfusion Process
Establishing an appropriate model allows for higher throughput during simultaneous operation and monitoring of several cultures at different process conditions. In this article, we discus…
Article
Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …