Downstream Processing

Aug 01, 2005
BioPharm International
Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.
Aug 01, 2005
BioPharm International
By BioPharm International Editors
Subcutaneous administration is likely to be an important factor in generating an immunogenic response.
Aug 01, 2005
BioPharm International
The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.
Jul 01, 2005
BioPharm International
Disposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.
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.
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