Regulatory Open Forum

What is the documentation to be supplied, if we want to implement a change of culture media to increase the productivity of the upstream process, after of manufacturing clinical material but before of submit marketing authorization?
I appreciate your comments,

​Hi, Alejandra -

The most critical documentation will be your demonstration of comparability between material made with the new and old process.  If you cannot establish comparability, your clinical and non-clinical studies will have to be repeated.  Depending on your situation, it may be beneficial to have an FDA meeting to discuss the criteria you will use to establish comparability, and/or your data on comparability, before filing the marketing application.

In addition, you should have in-house information documenting that the new raw materials are appropriate for use in manufacturing, and have appropriate qualification of any new vendors.

Best,

Cathy

What is the documentation to be supplied, if we want to implement a change of culture media to increase the productivity of the upstream process, after of manufacturing clinical material but before of submit marketing authorization?
I appreciate your comments,

• If introduced to the clinic, then the information about the change (new materials, process changes, comparability results) will need to be submitted to the IND/CTAs before the material can be used in those studies.  
• If you don't intend to use the material with the new cell culture media in the clinic, then you just include all this information in the BLA/MAA. But it would be good to meet and advise the authorities that such a change will be included in the marketing application. 

​Hi, Alejandra -

The most critical documentation will be your demonstration of comparability between material made with the new and old process.  If you cannot establish comparability, your clinical and non-clinical studies will have to be repeated.  Depending on your situation, it may be beneficial to have an FDA meeting to discuss the criteria you will use to establish comparability, and/or your data on comparability, before filing the marketing application.

In addition, you should have in-house information documenting that the new raw materials are appropriate for use in manufacturing, and have appropriate qualification of any new vendors.

Best,

Cathy

What is the documentation to be supplied, if we want to implement a change of culture media to increase the productivity of the upstream process, after of manufacturing clinical material but before of submit marketing authorization?
I appreciate your comments,

• If introduced to the clinic, then the information about the change (new materials, process changes, comparability results) will need to be submitted to the IND/CTAs before the material can be used in those studies.  
• If you don't intend to use the material with the new cell culture media in the clinic, then you just include all this information in the BLA/MAA. But it would be good to meet and advise the authorities that such a change will be included in the marketing application. 

​Hi, Alejandra -

The most critical documentation will be your demonstration of comparability between material made with the new and old process.  If you cannot establish comparability, your clinical and non-clinical studies will have to be repeated.  Depending on your situation, it may be beneficial to have an FDA meeting to discuss the criteria you will use to establish comparability, and/or your data on comparability, before filing the marketing application.

In addition, you should have in-house information documenting that the new raw materials are appropriate for use in manufacturing, and have appropriate qualification of any new vendors.

Best,

Cathy

What is the documentation to be supplied, if we want to implement a change of culture media to increase the productivity of the upstream process, after of manufacturing clinical material but before of submit marketing authorization?
I appreciate your comments,