Re: Expiration Dating

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Yes, companies do real stability tests to validate shelf life.  Shelf life
may not always be tested from Iot to lot.  The analysis or spec results are
given a range during stability testing which determines consistent
stability.   Expiration and certificates of analysis are usually generated
at time of manufacture.  There are some manufacturers who establish
expiration from time of distribution. The standard is day of manufacture at
which case, the certificate of analysis is also generated by the QC

There are various ways companies express lot numbers.  In certain cases,
such as monocolonal antibodies it would be best to contact each
manufacturer for their method.

tylee <> on 10/30/98 08:10:32 PM

Subject:  Re: Expiration Dating

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

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