Re: Expiration Dating

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From:tylee <tylee@itis.com> (by way of histonet)
To:histonet <histonet@magicnet.net>
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Histonetters (including Vendors),

Can anyone describe just how an expiration date is established? I suspect
these dates are, at best, just rough estimates. Do companies do real time
stability studies to validate the shelf life of the product formulated in
the identical manner as it is sold? Or, for instance, is there a standard
shelf life for IgG1s in a specific buffer at a certain concentration?

What about multiple lots of antibody from the same batch of monoclonal?
When does the clock start ticking...when the mAb is generated, or when the
bulk batch is dispensed into a specific lot?

Inquiring minds want to know.

Ty Lee
tylee@itis.com




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