Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
 We are sourcing a polymer coating to elute a drug substance and my team asked me if we only do biocompatibility on the final product alone.   Since this is a new polymer developed for our product I suggested there must be safety data on the polymer that was discovered during the supply audit and based on our risk analysis and purchasing controls used it was found to be suitable since they were chosen. 
I was wondering if biocompatibility on the final product as manufactured will not be enough since this is a new non-compendial excipient without a history of safety data with FDA.

I am beginning to think we made need to more testing on the polymer coating since they do not have any or very little since the company(coating) is small. not a good excuse.

Here's a statement right out of the biocomp guidance which would be a good source for me to show our team:

 

"This is particularly important when the combination of device components could mask or complicate interpretation of a biocompatibility evaluation. For example, if a metal stent has a polymer coating that may separate over time, then the results of a final device biocompatibility assessment may not fully reflect the longer-term clinical performance of the device, and biocompatibility evaluation of the stent with and without the coating may be needed. "

I read this to mean that you test the stent without and compare safety data with the coating on it. However, since the supplier might not have enough safety data to support the use of the polymer, does this require us ( the manufacture of the finished device) to submit bio data(have on file since they manufacture to our specs to verify this coating is safe for use and to ensure there was no masking in the final product?

I also looked at the new combination guidance and it did not discuss coating safety data requirements for the polymer.  this polymer manufacture isn';t doing a MAF, so the responsibility falls on us based on agreements. Any help will be appreciated.
thank you

It seems that you are touching on 2 separate topics: one, the safety of the stand-alone polymer and two, the safety of the device should the polymer coating fail. USP has been undergoing revisions so as to help applicants characterize polymeric materials of construction. USP <661.1> and <661.2> - although for packaging - can perhaps provide some guidance on how to best characterize the polymer and help you to provide rationale on the methodology developed and/or specifications/end-points/targets chosen. This is for the material of construction only. 
Evaluating the safety of the system.... Because over time a polymeric coating may separate or deviate from its originally intended physical design (a chemical change would be much more complex), it is prudent to test the system not just as intended to be used but also without the coating.


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Holly Bilinski, MS, RAC
Ann Arbor, MI
United States
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Original Message:
Sent: 15-Jun-2017 02:00
From: Anonymous Member
Subject: Safety Data for a Non-compendial new polymer coating, how much and what

This message was posted by a user wishing to remain anonymous

Hello,
 We are sourcing a polymer coating to elute a drug substance and my team asked me if we only do biocompatibility on the final product alone.   Since this is a new polymer developed for our product I suggested there must be safety data on the polymer that was discovered during the supply audit and based on our risk analysis and purchasing controls used it was found to be suitable since they were chosen. 
I was wondering if biocompatibility on the final product as manufactured will not be enough since this is a new non-compendial excipient without a history of safety data with FDA.

I am beginning to think we made need to more testing on the polymer coating since they do not have any or very little since the company(coating) is small. not a good excuse.

Here's a statement right out of the biocomp guidance which would be a good source for me to show our team:

 

"This is particularly important when the combination of device components could mask or complicate interpretation of a biocompatibility evaluation. For example, if a metal stent has a polymer coating that may separate over time, then the results of a final device biocompatibility assessment may not fully reflect the longer-term clinical performance of the device, and biocompatibility evaluation of the stent with and without the coating may be needed. "

I read this to mean that you test the stent without and compare safety data with the coating on it. However, since the supplier might not have enough safety data to support the use of the polymer, does this require us ( the manufacture of the finished device) to submit bio data(have on file since they manufacture to our specs to verify this coating is safe for use and to ensure there was no masking in the final product?

I also looked at the new combination guidance and it did not discuss coating safety data requirements for the polymer.  this polymer manufacture isn';t doing a MAF, so the responsibility falls on us based on agreements. Any help will be appreciated.
thank you