In the Lab: Racing Toward Inventions

From animal science to microbial detection, here’s a closer look at the work of two Charles River scientists whose inventions led to patents 

Every day, laboratories announce exciting breakthroughs or publish findings that, in large and small ways, change the world we live in. Sometimes those breakthroughs lead to patents for a new product or design. Meet two scientists whose names are listed on patents held by Charles River Laboratories and learn what factors helped to drive their inventions.

Advancing Research Animal Health and Diagnostics

Ken Henderson, PhD, DACLAM, has been with Charles River for more than three decades, but his first taste of working on groundbreaking research that produced a patent date back to his time at Ohio State University, where he earned his PhD in molecular virology and avian disease. The Ohio Agricultural Research and Development Center, where Henderson was doing post-doctoral work, was the first to develop a recombinant antigen for a protein used in both vaccine development and, importantly, as a diagnostic test for infectious bursal disease virus (IBDF). The test detects the presence of antibodies for IBDF in chickens.

“Some people call it the AIDS of chickens because what it does when it infects chickens, at least in the more severe cases, is cause the animals to hemorrhage throughout the body and destroy B cells responsible for making infection-fighting antibodies,” said Henderson. Because the disease wipes out their B cells, it leaves chickens vulnerable to opportunistic infections, just like HIV-infected people, he added. 

Henderson’s ability to produce recombinant protein antigens in baculovirus helped him land his next position at Charles River, which had a longstanding, worldwide reputation for producing high-quality research models. Henderson developed Charles River’s first recombinant protein protocols for producing antigens for diagnostic testing, which are still used today. 

Flash forward to 2015, and Henderson—now overseeing Charles River’s Research Animal Diagnostics Division—again found himself in patent territory. His name was listed on an invention held by Charles River that reflected a major advance in how we monitor animal research facilities for pathogens. The science was a major first step in helping companies slowly move away from using animals known as dirty bedding sentinels to screen for pathogens in their cages.  

Ken’s team refined an alternative method, known as exhaust dust PCR testing, that efficiently detects pathogens in the plenums of Individual Ventilated Cage (IVC) racks. The plenums are used to distribute filtered air to each cage and draw away exhaust without relying on open ports, but they are also prime real estate for detecting germs in cages. Allentown, a cage-monitoring company and the owner of the racks, holds the patent on its hardware, but Charles River secured a patent on the service.

Several years later, as EAD technology advanced rapidly, Charles River secured another patent, this time including Henderson’s name, on Pathogen Binder.™ This iteration of EAD PCR testing uses a protocol and contact media that optimize infectious agent detection and reduce variation in the sample collection process and in the diagnostic laboratory’s processing of the sample. More than 400 institutions have trialed or have implemented PathogenBinder™. 

Charles River’s patent was specifically around a design feature of PathogenBinder™, whereby the media in the animal cages is agitated to shake the bedding, forcing dust from the bedding to be captured by an air filter. Henderson says Charles River has also submitted patent claims for the use of an electron beam (E-beam) on their media, specifically in isolators containing genetically engineered mice or for extra biosecurity in facilities housing immunodeficient mice.  The decontamination of contact media with E-Beam radiation helps prevent the introduction of inapparent bacteria into the same work environment that is often shared with research mice.

For Henderson, the glory of a patent is nothing like the enjoyment he gets from lab research. Nonetheless, he says, it was nice to be recognized by the US government for doing something exceptional. “That’s the excitement about getting your patent, knowing that it’s based on technology that is helping to bring to the forefront a meaningful advance for the industry.”

A Design Upgrade to Make Endotoxin Testing More Efficient

Luca Nicoli, a mechanical engineer by training, redesigned the Endosfe® LAL cartridge dispenser used in an automated system introduced in the early 2000s. This new dispenser design was implemented alongside the release of a second-generation automated system that replaced the original. The disposable LAL cartridge, about the size of a credit card, helps companies screen for dangerous endotoxins that can turn up on parenteral products such as implants, injections, and IV medications, and pose a risk to patients. In 2018, Nicoli, Senior Director of US R&D for Charles River’s Microbial business, designed a dispensing system that enabled these cartridges to be easily loaded and accessed by the automation system, saving customers time.

“Typically, the cartridges are packaged individually, so someone had to remove the cartridge from their package and put them in the instrument one by one. So, I designed a gravity-feed dispenser system that presented the cartridges to the robotic system one at a time.”

Nicoli said the design is specific to the Endosafe product, but because competitors could conceivably replicate it for their own carrier systems, a patent application was filed. “This way we own the design,” said Nicoli.

While the design sounds simple, the work put into it was not. Nicoli created several different proofs of concept and tested them all. “In the very early stages, we do a lot of 3D printing, especially on the hardware side, and there are a lot of iterations and tweaks along the way. It’s easy to put something in a computer-aided system, but at the end of the day, you have to build it, and you have to test it, and it all has to meet customer expectations.”