Molecular Structure Analysis and Quantification Tool Introduced for At-Line Biomanufacturing

Novilytic released its first product, Proteometer-L short for “proteoform meter,” a kit for at-line molecular structure analysis and quantification. It is compatible with bioreactors and performs analyses of medicinal batches roughly every 10 minutes, according to Fred Regnier, PhD, company CTO and emeritus professor of chemistry at Purdue University, who adds that the novel technology enables process R&D scientists and drug manufacturers to recognize when a product run is going awry in near real time.

“This quick analysis saves up to six-plus hours a day and over $1 million per batch, increasing both profits and FDA compliance,” says Regnier. “The Proteometer kit is designed as a ‘plug and play’ consumable, ensuring easy adoption in almost all of the more than 250,000 instruments currently used in the pharmaceutical industry.”

Novilytic’s first product launch comes on the heels of pilot programs with large instrument manufacturers and CDMOs, continues Regnier, who notes that these pilots have led to discussions for sales contracts that the company hopes to announce soon.

“The goal of our numerous pilot programs was to demonstrate that our solution works in potential customers’ laboratories, not just ours,” says Paul Dreier, Novilytic CEO. “We are thrilled to share that our customer training was less than one hour, and the pilot data looks as good and even better than ours in many cases.”

Funding from multiple investors

The development of the Proteometer-L was made possible due to a $1.6 million funding round with multiple investors, including the Purdue Research Foundation. These funds provided the basis for Novilytic to test multiple drugs currently on the market to show that the patented Luminon^® and MASC^® technology works in a real-world setting.

“Novilytic’s technology represents a major disrupter in the pharmaceutical manufacturing industry. It could lead to enhanced FDA compliance in a day and age where transparency and accuracy are paramount,” said Riley Gibb, associate director of Purdue Ventures. “We’re extremely proud to have them in our portfolio of early-stage startups and are looking forward to both the industry reaction to this product as well as Novilytic’s future offerings.”

In addition to the investment, Purdue Research Foundation worked with Novilytic to create a technology licensing and servicing agreement and provided several industry connections that have resulted in strategic partnerships for the company.

Fred Regnier founded Novilytic and joined as the CEO in 2014. The company was originally created to develop medical device blood cards and methods and is producing that product today. He has co-founded five analytical science companies, one of which was PerSeptive Biosystems (PBIO) which was sold to Perkin Elmer for $384 million in January 1998.

Regnier held the J.H. Law Distinguished Professor of Chemistry position at Purdue University. He has co-authored 306 peer-reviewed publications in the fields of chromatography, proteomics, and metabolomics and holds 47 patents in analytical and diagnostic science. He was the CSO at PBIO for three years, directing an R&D staff of about 100.

The post Molecular Structure Analysis and Quantification Tool Introduced for At-Line Biomanufacturing appeared first on GEN – Genetic Engineering and Biotechnology News.

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