Production of raw materials in university labs?

#1
Hi all, I´m a noob here so be gentle! Our institute has designed a medical device that will be incorporated into a combined ATMP. Our chemist wants to cut costs of a raw material (a coating for a tissue culture plate) and believes that if the material is made in our university lab, it can then be sent to an outside company to get a CoA and can subsequently be used in the medical device. What are we missing here - we have no ISO 13485 or any similar quality management system. Thanks for any help.
 
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William55401

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#2
You can certainly have a lab assist you with testing to show conformance to specification. However, manufacturing in your laboratory would fall under 13485.
 
#3
Thanks William. So we would need 13485 to make a raw material that becomes part of the medical device. The device consists of plasticware and a coating made of two materials and all three parts need to be manufactured under 13485, correct?
We don´t have 13485, but we can manufacture the raw material and have it tested by a company that does have 13485 - is this an option? I´m guessing not, but if the material is shown to conform to specification, as if purchased elsewhere, how does 13485 make a difference? Thanks.
 

William55401

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#4
Updated post. I would need to understand more about the functionality of your medical device and what role each component plays. There is no explicit requirement for components to comply with 13485. Finished medical devices must comply with 13485. (This assumes you are entering the EU market). Given that this is a public forum, I would be happy to enter into a private discussion. Or, feel free to share more on this thread and you will unleash the full power of the Cove. Key questions to get you a better answer.

What is the intended use?
What are the roles of each component?
What components are made where? In your lab vs at suppliers?
Who packages and labels the final finished device?
 
Last edited:
#5
Well I need all the help I can get so I´m happy to share with the cove.

The device is a polymer coated tissue culture plate and the intended use is to expand primary human cells for transplant into the eye. The device is combined with culture media and cells into a therapeutic product. We only make the medical device for our clinical partners, who create the combined ATMP.

For the medical device, the components are (1) a plastic tissue culture plate from a catalog supplier e.g. ThermoFischer, (2) a peptide conjugate that will be synthesized by a 13485 certified company and (3) a coating polymer that is made by us in our research lab. The components will then be sent to a 13485 certified company for assembly, packaging, labeling and sterilization.
So the question is whether our lack of 13485 for (3) is a no-go, or does this not matter as the finished device will be assembled under 13485 in any case?
 

William55401

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#7
good question from Mushroom. Put another way, will your org be the legal manufacturer that places the medical device on the market?
 
#8
Thanks guys. The owner of the medical device is a spin.out company, which will be the legal manufacturer that places the medical device on the market. The university labs in which the company wishes to produce one of the raw materials is not 13485 certified. As the future owner and manufacturer of the device, the company is currently working towards 13485 certification.

I am unsure if the idea of manufacturing in a non-ISO certified lab would be acceptable to 13485 (in which case we would fail the audit)?
 

William55401

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#9
The legal manufacturer is responsible for supplier oversight. This would include defining Quality Mgmt Systems requirements (or not) for component suppliers. Many component suppliers choose to get certified. Certainly, the legal mfr will want to ensure process and material controls are in place for your laboratory. I suspect your legal manufacturer has identified a Notified Body (NB) to get their QMS certified. In certain cases, NB may audit suppliers but that is more typical for finished device suppliers. To totally lock your strategy down, consider routing your question through your legal manufacturer responsible for the product who can consult the NB. Your legal manufacturer has to be on board with no QMS plan. good luck
 

Sidney Vianna

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#10
Our chemist wants to cut costs of a raw material (a coating for a tissue culture plate) and believes that if the material is made in our university lab,
There are labs and there are LABS. How structured is this lab? Puting the legal aspects aside for a minute, your words in the original post are telling: cost-cutting. Some of the BIGGEST BLUNDERS in the business world, some that lead to hundreds of fatalities can be traced back to "cost-cutting good intentions".

Be very careful; after all, we are talking about a medical device here. There are reasons for regulations and heightened expectations in this sector, as the consequences of poorly controlled operations can be dire to the end users. There are good reasons for academia labs not to be used for commercial purposes and vice versa.

Good luck.
 
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