[RASMB] Precision of c(s) method

[Parker, Matthew]

Hi folks.

 

            I was wondering if people could give their views on the degree of
precision that can be expected from the c(s) method, or other methods for
fitting SV data, for assessing the degree of aggregate formation in a protein
sample. (Monoclonal antibodies, in particular.) The FDA is starting to ask
for "orthogonal methods" to back up SEC data on aggregate formation. Is it
reasonable to expect that SV can give the same degree of reproducibility when
dealing with, say, 1 to 5% aggregated species? Has anybody done any
systematic determinations of the precision of the method? (Subjective
impressions are also welcome!)

 

            Thanks,

 

            Matt

 

Matthew Parker, Ph.D.

Analytical and Pharmaceutical Sciences

Immunogen, Inc.

128 Sydney St.

Cambridge, MA 02139

(617) 444-2028

(617) 995-2544 fax

matthew.parker at immunogen.com

 

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