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Aug. 6th, 2010

Doеs anybody know anything about FDA regulations for protein A contents for monoclonal antibodies (mAb) production?
What are the current FDA regulations & guidlines for mAb manufacturing and purification?
Answers like "go search FDA site" are not acceptable, there are tons of regulations, guidlines and references there, hell knows which are exactly relevant to my questions. However if you know exactly the link to the FDA information that is relevant to me, then please share it with me. If you personaly don't have any knowledge of the subject, but know somebody who does, I would appreciate if you help me to get in touch with this person.


( 2 comments — Leave a comment )
Aug. 7th, 2010 11:52 am (UTC)
you won't find it at the FDA website
you've got to get around the protein a pharmacopeia monograph
RA or quality dept of your company is a good place to search for it
you could try torrents though
or buy it from the USP-NF website
Aug. 7th, 2010 08:02 pm (UTC)
There is a WCPB conference (well characterized proteins and biologics). It typically takes place in DC and SF, they alternate in January. This year it's DC. It exactly the forum there these things are discussed and it's planned as interface between industry and regulation agency. They usually have a lot of FDA people and few from EMEA. For example last year Genentech and Amgen regulatory people presented show case on their mABs.
( 2 comments — Leave a comment )