Search results for " scaling"
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Under pressure: exploring root causes of leaks in single-use mixers
Single-use technology offers huge benefits for both flexibility and efficiency. It reduces downtime by eliminating cleaning steps, helps avoid risk of cross-contamination, and enables modulari…
Article
Considerations in depth filter scale-up
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in diffe…
Article
Selected courses from cell culture and downstream process development to scale-up and manufacturing
Examples of available free of charge eLearning courses:
What is quality by design (QbD)?
Principles of cell line development
Bioreactor scaling
Filtration in bioprocessin…
Article
Innovations in Perfusion Bioprocessing
In this study, we present a method for deriving perfusion culture media by leveraging existing fed-batch media and feeds.
Furthermore, we illustrate the successful transfer of the develop…
Article
Evaluating the Use of Continuous Chromatography
Continuous processes continue to advance in bioprocessing. In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharma…
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
About this talk
Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics Presented by Irina Ramos, Director, Bioprocess Technology and…
Article
Bioprocess filter selection guide
Filter selection can be a daunting task, and with so many options available, it’s hard to know what is right for your process. This new bioprocess filtration selection guide can help get you o…
Article
Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …