Search results for "qbd"
Article
Improving Upstream Predictability
Better understanding and control of cell behavior is yielding benefits, upstream and beyond.
By Agnes Shanley
In the earliest days of biotech, developers often struggled to sust…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
…ith design of experiments (DoE) and multivariate data analysis (MVDA), support a quality by design (QbD) approach to process development. These approaches can generate meaningful process data faster …
Article
Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
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The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
Article
2019’s Top Bioprocessing Trends and What to Expect in 2020
QbD, Regulatory, and Validation Considerations
Viral clearance is a topic on the minds of many in the biopharma industry, and for good reason. Considering the manufacturing challenges experienced …
Article
Risk Assessment: Studying Chromatography Resin Variability
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Many factors can give rise to process variability, such as variation in different process parameters or raw materials. This article focuses on process robu…
Article
Raw Material Variability: The Need for Deeper Process Understanding
Principles and methodologies for biopharmaceutical development and manufacturing are well established today. However, the increased molecular diversity and drive for higher productivity brings new c…
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
I think this could be very important in the era of QbD and increased process understanding.
Read more Q&As with Industry Leaders Here
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
In addition to assessing factors and conditions for the optimization of the purification steps, the quality-by-design (QbD) initiative introduced by FDA requires a deeper understanding of critical pro…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…s processing can facilitate real-time testing approaches and can support FDA’s quality-by-design (QbD) initiatives (4). Biotechnology products, when run continuously, can be sampled regularly, and an…
Article
Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…