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Posted On: 07/11/2020 8:47:51 PM
Post# of 148908
Np mentioned this in the call at 1:59 I think
Comparability
• Biologic products undergo multiple manufacturing changes during clinical development and after approval.
• The goal is to demonstrate that pre and post change products are highly analytically comparable and that any observed differences are unlikely to impact clinical performance. Otherwise clinical or animal studies may be required.
• The more potential the manufacturing change has to alter critical quality attributes of the product the more comprehensive the physiochemical study should be.
• Using irradiated serum vs change of filter
22
RETAINS, RETAINS, RETAINS
• Manufacturing changes are common in Biotech
• Should link critical quality attributes to those found in the clinical trial material
• Make sure retains are stable (-70oC)
•Also critical during analytical assay development
-As technologies improve they may detect things not seen with older assays. Retains allow you to determine if they were always present.
Comparability
• Biologic products undergo multiple manufacturing changes during clinical development and after approval.
• The goal is to demonstrate that pre and post change products are highly analytically comparable and that any observed differences are unlikely to impact clinical performance. Otherwise clinical or animal studies may be required.
• The more potential the manufacturing change has to alter critical quality attributes of the product the more comprehensive the physiochemical study should be.
• Using irradiated serum vs change of filter
22
RETAINS, RETAINS, RETAINS
• Manufacturing changes are common in Biotech
• Should link critical quality attributes to those found in the clinical trial material
• Make sure retains are stable (-70oC)
•Also critical during analytical assay development
-As technologies improve they may detect things not seen with older assays. Retains allow you to determine if they were always present.
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