Search results for "bioprocess"
Article
Driving Change in Biomanufacturing
Implementing a new technology into a bioprocess is a big change. The new technology must be fully understood, all regulatory requirements fulfilled, the quality of the product output secured, and a th…
Article
Connected Polishing and Concentration Under One Automation Method
Chromatography and tangential flow filtration (TFF) steps are traditionally performed as separate unit operations in downstream bioprocessing. This work aims to demonstrate the capability of the UNICO…
Article
Start With the End in Mind: GMP Tech Transfer
How can you be one step ahead in process development and prepare for future GMP work?
Hear what tech transfer experts have to say about this important issue in this blog. And, learn how to apply …
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
ASME, Bioprocessing Equipment (BPE) p. 52 (2012).
11. G. Verghese and N. Kaiser, “Cleaning Agents and Cleaning Chemistry, Chapter 7” in Cleaning and Cleaning Validation Volume I, P. Pluta Ed. (D…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Bioprocess. 3 (8), 477-487 (2015).
11. Y. Hou et al., Biotechnol. Prog. 31 (4), 974-982 (2015).
12. J. Chen et al., J. Chromatogr. A. 1177(2), 272-281 (2008).
13. G. Mies…
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges.
• The increased upstream titers in mA…
Article
How to Address Bioburden Challenges: Insights and Tips
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
Fusion Proteins Pose Manufacturability Challenges
…ation of ultraviolet C (UVc) radiation for inactivation of viruses at process scale, and continuous bioprocessing will be beneficial for fusion protein manufacturing.
New design strategies
Wh…