Mission

Automated Monocyte Activation Testing Technology for Microbial  Detection

PyroDex’s full commitment to microbial detection helps you save time and money.

Our mission is to help medical device and drug makers increase success rates in clinical trials and accelerate commercialization.

PyroDex is a biotech company founded to offer a focused service of rapid, comprehensive detection of pyrogenic contaminants in injectable or implantable medical drugs and devices, using technologies that do not rely on animal testing or animal products.

Our service focuses entirely on testing injectable and implantable therapeutic products for microbial contamination, using an automated MAT technology that’s:

• Fast

• Comprehensive

• Reliable

• Quantifiable

We partner with manufacturers and clinicians to provide a focused, rapid and comprehensive pyrogenic contaminant detection service using technologies that not rely on animals or animal products.

Vision

Safer drugs and better treatment for all at affordable costs.

We envision that PyroDex detection systems will become the method of choice to rapidly and reliably test the safety of therapeutic products in the biopharmaceutical industry. To demonstrate the superiority of the technology, and its importance to protect public health and investment, we intend

1. to partner with manufacturers and clinicians to provide a focused service of rapid safety tests with a short turnaround; and

2. to provide the necessary tools to support regulatory decisions regarding therapeutic product safety.

Mission

To help medical drug and device makers increase clinical trial success rates and accelerate commercialization, through a focused, rapid and, comprehensive pyrogenic contaminant detection service using technologies that do not rely on animals or animal products.

Core Beliefs

1. That more comprehensive testing to detect possible contaminants will result in safer drugs and medical devices for clinical trials, better and more successful treatment, more lives saved, and better return on investment; and

2. that many clinical trial failures are due, not to the inefficacy of medical drugs or engineering design flaws, but to contaminants that current safety testing methods do not detect.

Credentials

Djik Maouyo, Ph.D.

Djikolngar Maouyo, Ph.D., is the founder and managing director of PyroDex LLC. Dr. Maouyo has more than 25 years of experience in industrial biotechnology and academic biomedical research, and has focused specifically on microbial detection for the past nine years. He has worked intensively in the development of microbial detection kits and researched budding technologies in microbial detection throughout the United States and Europe for the past five years.

Prior to founding PyroDex, he held faculty research positions at the Johns Hopkins University School of Medicine and the University of Maryland Baltimore, and most recently was senior scientist at a multinational biotech firm. He has a Ph.D. in animal physiology from the University of Sherbrooke in Canada and has held postdoctoral fellowships in microbiology and molecular biology, at the University of Montreal and the Johns Hopkins School of Medicine respectively.

Industrial Expertise

We have experience in microbial contamination detection:

• Good manufacturing practices

• Good laboratory practices

• International Standard Organization

• US & European Pharmacopeia Testing Guidelines