Does anybody have an idea on what is more critical for the stability of
lyophilized proteins for human injection? We have products that last a
little more than one year, being slowly degraded or altered, possibly
with the formation of dimeric, deamidated or sulphoxidated forms. But we
need 2-3 years stability. What is more critical? Type of excipient
(glycine, mannitol, lactose, etc.), residual moisture, type of vial or
stoppering, lyophilization conditions ?
Thank you.
Paolo Bartolini
Biotechnology Department
IPEN-CNEN/S“o Paulo-Brasil
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