Endotoxins Are Not All The Same. We Shouldn't Test As If They Are.
Safety testing is critical in the medical field, especially when it comes to injectable drugs and implantable devices. However, traditional U.S. compendial safety testing methods have shown significant limitations. They are unable to detect all the chemical and microbial contaminants that can negatively affect the quality of these medical products. This is where PyroDex LLC steps in.
Our Mission: Revolutionize Safety Testing
PyroDex was founded with a groundbreaking mission: to revolutionize safety testing methods. Its core detection system, the Monocyte Activation Test (M.A.T.), is an agnostic biotechnology based on the use of human blood cells. This method offers a more comprehensive approach to safety testing, capable of detecting a wider array of contaminants than conventional methods.
Our MAT Implementation System
PyroDex's laboratory has developed an innovative semi-automated MAT implementation system. This system uses pooled human peripheral blood mononuclear cells (PBMCs) as an alternative to conventional endotoxin detection methods like the rabbit pyrogen test and the horseshoe crab blood-based Limulus Amebocyte Lysates (LAL), the current primary method for detecting lipopolysaccharides (LPS).
Importance of Differentiating Endotoxins
LPS, a structural bacterial component, can cause severe conditions like fever, sepsis, multiple organ failure, and even death. However, not all endotoxins are the same. Some are pyrogenic (fever-causing), and others are not. This crucial distinction is undetectable using current standard bacterial endotoxin tests. The MAT, however, is perfectly equipped to differentiate between them.
Advantages of MAT
There are several reasons why MAT stands out:
It can detect pyrogenic lipopolysaccharides (those that are physiologically and clinically relevant), as well as non-lipopolysaccharide pyrogens.
It does not require prior knowledge of a contaminant’s molecular structure for detection, a distinct advantage over other bio-detection technologies.
PyroDex's MAT processes can distinguish between pyrogenic lipopolysaccharides and non-LPS pyrogens.
Unlike other standard methods, the MAT does not rely on animal testing or animal products.
The MAT offers a comprehensive view of the bio-safety status of implantable devices and parenteral drugs, making it a vital tool for making definitive business and regulatory decisions about the safety of therapeutic products. It also provides rigorous quality control of raw materials, in-process, and finished products.
Adoption and Acceptance of MAT
Introduced in the European Pharmacopeia in 2009, the MAT was adopted as a compendial pyrogen testing method in 2016, replacing the rabbit pyrogen test. It has since gained worldwide acceptance, although the United States has been slower to adopt it.
PyroDex Lab and its role in the U.S.
The PyroDex laboratory is the first in the U.S. dedicated entirely to safety testing services based on the Monocyte Activation Test. Its unique MAT method is different from those included in current commercially available kits and is vastly superior to both commercial endotoxin detection and MAT kits.
PyroDex's goal is to serve the United States and the world by offering a foundation and systems for relevant safety testing of therapeutic products. This includes medical parenteral drugs and implantable devices, for safer and more effective treatments and improved return on investment.
Dr. Djikolngar Maouyo
The founder, Managing Director, and President of PyroDex LLC, Dr. Djikolngar Maouyo, has made significant contributions to this field. With a background in rapid microbial detection, he is highly respected as a world leader and go-to expert in Monocyte Activation Test science and technology. His expertise and the innovative work of PyroDex are paving the way for a more effective and comprehensive approach to safety testing.