Downstream Processing

Jan 01, 2005
BioPharm International
Protein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
Jan 01, 2005
BioPharm International
In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.
Jan 01, 2005
BioPharm International
By BioPharm International Editors
Manufacturing changes — such as changes in formulation or source material — can impact a product’s immunogenicity.
Jan 01, 2005
BioPharm International
By BioPharm International Editors
The drive to develop better, faster, and smaller — in other words, more efficient — products is a universal trend in the modern world. This trend has profoundly impacted many industries from microelectronics to packaging equipment. In the biopharmaceutical industry, the need to speed and simplify the long and complex drug manufacturing processes brings additional challenges, such as meeting regulatory requirements.
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