Downstream Processing

Jun 01, 2005
BioPharm International
An anionic column with modified chitosan bead matrix performs well in purifying cell culture. A pair of cationic-exchange columns shows promise in purifying S25 antibody.
Jun 01, 2005
BioPharm International
By BioPharm International Editors
In a mere 30 years of development, a total of 23 MAbs and MAb-related proteins have been approved for medical treatments.
May 01, 2005
BioPharm International
Saturated fractional factorial plans minimize the number of trials by one-half or better, which saves time and money.
Apr 01, 2005
BioPharm International
By BioPharm International Editors
When you don't know the answer to a question, ask an expert. If the question is really big, ask more experts. If you have a collection of difficult questions, run a poll of many experts. That, in effect, was the impetus for Eden Biodesign to survey 670 BioPharm International subscribers with questions as to what will be the development mechanism to achieve safe, effective, and cheap new medicines.
Apr 01, 2005
BioPharm International
By BioPharm International Editors
Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.
Feb 01, 2005
BioPharm International
By BioPharm International Editors
Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality.
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
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.
native1_300x100
lorem ipsum