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Are there any labs that have the testing capability to assess microbial profiles of starting cultures


drronnie

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My wife is a PhD candidate in microbiology at Chulalongkorn University. From what I know about her program, I would think you could obtain the analysis you need at any of the Thai universities that have good science departments that offer graduate programs in microbiology. Some suggestions are Chulalongkorn, Mahidol, and Thammasat. I am sure there are others. 

 

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Charlie,

 

FDA stands for Food and Drug Adminstration.

 

As I understand it, these profiles would be use to show active cultures and the safety of a product.

 

But your desire for analysis of you microbial biome is an interesting idea.

 

Best Wishes,

Don

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I'm new to this forum, but 30+ years standing in microbiology (microbial ecology, military defense and now mediical diagnostics).

 

For FDA approvals, you can't just rock up to your nearest university for an analysis. The FDA won't accept that. You need to find a properly accredited laboratory/assay house. Getting anything FDA is a (rightly) expensive and long process. Which is why many companies instead aim for EU CE marketing approval. It (was) much simpler (new regulations mean not so now). They get that little mark, and find its a lot easier to make sales in less regulated markets across the MEA/APAC.

 

I would recommend reaching out to a proper testing service, such as TUV Rheinland Thailand, and starting a conversation. If you are asking where to get a microbial assay done on a product, you've probably skipped a lot of steps that the FDA need to know about how you made the thing, and whether you followed a process to an acceptable standard.

 

There is a little known fact about why the FDA exists that is connected to today's Pandemic. Back in the early 50s, Jonas Salk came up with the first Polio vaccine. It was seen as a miracle; the globe had been through 40 years of waves of outbreaks. The US government quickly put out a contract for 6 million doses, to be delivered untested into the arms of American kids. Clinical trials didn't really exist then. Contracts went out to 3 companies. The recipe for the vaccine was provided to each. Key was the use of formaldehyde to kill the polio virus. One company didn't really understand how to make formaldehyde, and so 200,000 doses went out with live virus. It didn't dampen enthusiasm at the time for the vaccine, but lessons were learned. The FDA was formed to make sure someone checked that manufacturers knew what they were doing. That the process in the lab could be replicated at scale, that there was a QC process in place etc.

 

So going on a forum asking where in Thailand you can get a microbial study completed to support a FDA application probably  indicates you need to be schooled on the rest of the process.

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