Downstream Processing

Feb 02, 2007
BioPharm International
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
Feb 02, 2007
BioPharm International
This article explores the development of process chromatography. Process chromatography was first applied to the removal of low molecular weight solutes from whey by gel filtration about 50 years ago. An analytical method using size exclusion chromatography was scaled up for insulin production in the 1970s, when ion exchange became a viable technology for the same application. Ion exchange was adopted as the industry workhorse as robust resins became available and formed the backbone of chromatographic processing of blood plasma fractionation in alternatives to and extensions of ethanol precipitation.
Feb 02, 2007
BioPharm International
This article presents the multicolumn countercurrent solvent gradient purification (MCSGP) process, which uses three chromatographic columns, and incorporates the principle of countercurrent operation and the possibility of using solvent gradients. A MCSGP prototype has been built using commercial chromatographic equipment. The application of this prototype for purifying a MAb from a clarified cell culture supernatant using only a commercial, preparative cation exchange resin shows that the MCSGP process can result in purities and yields comparable to those of purification using Protein A.
Jan 01, 2007
BioPharm International
By BioPharm International Editors
The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
Dec 01, 2006
BioPharm International
Conducting an analysis of the 4 Ms—man, machine, methods, and materials—enables companies to identify the true root causes of deviations.
Nov 09, 2006
By BioPharm International Editors
In recent years, disposable membrane chromatography has gained acceptance as a robust device for large-scale processing.
Nov 09, 2006
The many benefits of disposable technologies, such as significant savings in time, labor and capital, as well as ease of scalability and flexibility, have led to the growing trend of adopting disposable technologies in bioprocess manufacturing processes.
Nov 02, 2006
BioPharm International
By BioPharm International Editors
Filtration systems exemplify disposable technologies that can be presterilized.
Nov 02, 2006
BioPharm International
Biopharmaceutical processes typically require a significant investment in equipment—often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.
Nov 01, 2006
BioPharm International
This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.
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