Tag: <span>filtration</span>

The aim in process filtrations is to purify the liquid preparation by removing particulate impurities while obtaining as large a throughput as possible under practical conditions. The rate of flow should be expeditious enough to meet time constraints when necessary. This places a focus on the applied differential pressure level that motivates the liquid flow. A balance must be sought. Higher differential pressures increase the flow rates but may decrease throughputs by compaction of the filter cake. Also, higher applied pressures may minimize the adsorptive retention of particles. Deciding which is the proper filter involves small-scale filtration trials. The choice of the filter having been made, its size, in terms of the area necessary for the processing of the production batch, is arrived at by extrapolations from the small-scale tests that were performed…

Biologics Production

The Vmax™ technique has been used extensively to estimate filter area requirements for normal flow filtration (NFF) processes in biopharmaceutical applications. The benefits that this technique presents over conventional flow decay methods are the speed of testing, reduced volume requirements for evaluation, and competitive testing of varying filter types/sizes — all of which present an optimized filter screening strategy and preliminary estimate of optimized filter size requirements. Filter size or filtration area requirements derived using the Vmax technique consist of contributions from both capacity and flow-time aspects of the filtration process. This article examines the relative contributions of these terms to overall filter sizing vis-à-vis the ease of fluid filterability…

Biologics Production Uncategorized

Adenoviral vectors (AAV’s) offer a promising new approach to vaccine development. They have the ability to be rapidly manipulated for bearing transgenic coding for specific antigenic proteins, efficiently infect a variety of mammalian cell types (including antigen-presenting cells) and induce a broad immune response against the target antigen in vaccine recipients. Furthermore, AAV’s offer an excellent safety profile, in that they can be engineered to be non-replicating in the vaccine recipient and they lack the molecular mechanism for integration into the host genome. AAV’s are highly amenable to scalable manufacturing processes such as the use of stirred tank bioreactors, high capacity filtration methods, and chromatographic purification procedures…

Biologics Production Viral Vectors

Manufacturers must demonstrate, with a very high degree of assurance, that biopharmaceutical products derived from mammalian cells or from human plasma are safe and free of viral contamination. Viruses can be physically removed from most proteins using filtration. Often air diffusion is used as a nondestructive test to ensure that a process filter is installed properly and free of defects that can compromise virus retention. In this article, theoretical models were used to relate air and liquid flow rates through integral and defective filters. The effect of defect diameter and defect density on the virus retentive ability of a filter was also modeled…

Manufacturing