96

Contamination Control Compass
Edition #07/2024

 

Informative Articles
Digital PCR made easy: Frequently used terms

In the world of digital PCR (dPCR), there are words that appear frequently in scientific publications. Knowing and understanding these common terms is essential in order to understand the topic of dPCR and to understand and contribute to the scientific literature.

Discover the terminology of dPCR explained in simple terms to gain a better understanding of the novel quantification method.

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Regulatory Changes
USA accept animal-free procedure of endotoxin testing

Photo: pixabay.com | Pexels

What has been permitted in the European pharmacopeia since 2018 is now also permitted in the USA – The recombinant Factor C (rFC) test has finally been accepted by the US pharmacopeia and will become official in May 2025. This test copies the LAL test and uses recombinant Factor C. The protein is produced recombinantly by genetically modified microorganisms and thus replaces the naturally occurring Factor C in the blood of horseshoe crabs. More precise results can be achieved and no animals have to suffer and die for it.


But be aware! The rFC test as well as the LAL-test only detect endotoxin pyrogens. Non-endotoxin pyrogens can only be detected by a complete pyrogen test- such as our NAT-MAT®

Check out all benefits

You can read the original article published by the USP here.

 
 

Product Highlights
Coming soon: Complete pyrogen testing by combining the power of digital PCR with MAT

In the pharmaceutical industry, pyrogen detection is mandatory to avoid life-threatening fever reactions that can be induced by both microbial and non-microbial substances.

Minerva Biolabs has developed a next generation MAT system that measures the gene expression of IL-1β and TNFα using digital PCR - the NAT-MAT®. The NAT-MAT® enables complete pyrogen testing and detects endotoxin as well as non-endotoxin pyrogens. The test can be conducted as in-process control and as final release testing of medicinal products according to Ph. Eur. 2.6.30.

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Beta Testers Wanted!

Minerva Biolabs is looking for suitable testers for NAT-MAT®. Send a mail to miquant@minerva-biolabs.com to get more information.

 

Here's to clean cultures and reliable results!


Warm regards,

Your MB Team

 

Do you need technical support or have questions regarding our products? Please contact support@minerva-biolabs.com. Any feedback or suggestions? Write an email to newsletter@minerva-biolabs.com.

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