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Anti-Leaching Solutions Featured on SLAS2016 Innovation AveNEW

If a tree falls in a forest and no one is around to hear it, does it make a sound? Similarly, if an innovator has a good idea but no means of spreading the word, can the idea move forward to successful implementation? The SLAS Innovation AveNEW program gives life sciences discovery and technology start-up companies a forum to put their good ideas in front of the global community for collaborative interaction and exposure – and a fighting chance for success in the marketplace. 

In 2011, SLAS member Lynn Rasmussen experienced a curious anomaly while running a screen.

“We were part of the National Institutes of Health (NIH) Molecular Libraries and Imaging Program,” says Rasmussen, supervisor of the high-throughput screening center at Southern Research in Birmingham, AL, a drug discovery company that owns part of seven U.S. Food and Drug Administration-approved drugs on the market. “They resupplied us with the compound library every year, so after three years we had three copies. We were seeing an artifact, large numbers of active wells around the perimeter of the assay plates. This was statistically not likely, and we had some concern about the actual library plates we were using. We compared compound library plates from all three copies and it was only in compound plates from the middle copy that we observed the artifact. Our speculation was that the compound source plate had a component that was leaching into the assay and producing the artifact.

“We were lucky and had the resources to track down where the artifact was coming from, although we didn’t pursue identification of the actual leachate, which is a labor intensive and expensive proposition,” she adds. “The problem of leaching is not so much that it’s going to derail a drug discovery program, but what it can do is send you off the track, and cause you to spend a lot of money and time pursuing artifacts. Most high-throughput laboratories don’t have the analytical capability to actually identify the leaching component that is causing the artifact. Generally, you will test plates or tubes from a number of suppliers; then go with the one that works and not worry about the ones that gave you the artifacts or poor quality data.

“Around this same time, an article on the problem of leaching came out in a Society publication,” she continues. “At the end of that article it said, ‘for more information, contact,’ and it had an e-mail address. I sent an e-mail and the next thing I know, I’m chair of a new SLAS Special Interest Group (SIG),” Rasmussen jokes. She remains chair of the SLAS Labware Leachables SIG.

In 2016, the hard work done over the past several years by SIG participants began to pay off, as a number of companies began offering new solutions to the problem of leachables. Two companies, SIO2 Medical Products and Click Bio, were among those invited to participate in SLAS2016 Innovation AveNEW at the SLAS2016 5th Annual International Conference and Exhibition in San Diego.

Collaboration with SLAS Leads to a New Application for an Existing Technology

SiO2, based in Auburn, AL, offers a line of pharmaceutical packaging products – i.e., syringes, vials and cartridges – that are precision molded from medical-grade plastics, with interior drug contact surfaces that have a thin, transparent, silicon-based coating system. These products are engineered to combine the durability and dimensional precision of plastic with the barrier properties of glass.

“Once the coating is applied with our proprietary plasma technology, the surface is ultra-clean with extremely low levels of extractables,” Brian Maurer, senior vice president in the SiO2 Advanced Bioscience Labware Division, explains. “The barrier coating is a quartz-like layer approximately three orders of magnitude thinner than the diameter of a human hair.”

Maurer recalls walking into SiO2 last year as a new hire, and being asked, ‘Where else can we use this unique plasma technology?’ Longtime SLAS member and diagnostic devices consultant Amer El-Hage helped provide that answer when he learned of SiO2 late in 2014 while researching American companies for foreign investors.

“I ran the SLAS Microplate Standards SIG for eight years,” says El-Hage. “Our work resulted in five American National Standards Institute standards – footprint dimensions, height dimensions, bottom outside flange dimensions, well positions and well bottom elevation. I met Lynn (Rasmussen) during this time because of her work with microplates.” 

El-Hage alerted Maurer to the struggles discussed in the SLAS Labware Leachables SIG. Maurer immediately saw how SiO2’s process technology, based on plasma chemistry, could be valuable in the laboratory consumables market.

“During our plasma vapor deposition process, we coat or treat the interior surfaces of different types of labware consumables,” Maurer explains. “Once we introduce the desired coating or treatment to the surface, it is covalently bonded to the labware and does not introduce extractables species. In fact, our plasma coating technology gives extremely low levels of organic and inorganic extractables, and the resulting coating gives the best balance of oxygen barrier, moisture barrier and transparency of any polymer on the planet. Our ultra-low binding treatment technology also reduces binding of sticky molecules at low concentrations without adding extractable components. We believe that these capabilities are extremely important to minimize labware leachate issues.”

El-Hage, who is now a paid consultant with SiO2, invited Maurer to meet with the SLAS Labware Leachables SIG at SLAS2015. “During SLAS2015, one of our members gave a talk about where the plastics used in injection molding come from, and how little control they have over the feed stocks they get, which was a little disturbing,” says Rasmussen. “Following the meeting, Brian and I had an initial discussion on the SiO2 technology in Washington, DC.” In April 2015, SiO2 group members joined Rasmussen and her team members in Birmingham, AL for more detailed dialog at Southern Research.

In July 2015, SiO2 made a business decision to expand their technology into the labware consumables market. A few months later SiO2 submitted an application to SLAS and won a spot on SLAS2016 Innovation AveNEW.

Rasmussen also invited SiO2 to review their ultra-clean and ultra-low binding technology at the SLAS2016 Labware Leachables SIG. SiO2’s chief scientist, Chris Weikart, gave a thorough review of SiO2’s technology with the Labware Leachables SIG that was well received.

SiO2, while new to drug discovery and diagnostic markets, aims to stay involved with SLAS in a big way. The company’s appearance on SLAS2016 Innovation AveNEW illustrates how collaborating with those who have long been involved with SLAS can both help to find solutions for problems in the industry and bring new products to market, creating a win-win situation.

Maurer said that the company’s decision to get involved in SLAS is paying off. “One of the things required to get a slot on Innovation AveNEW is that we needed to have a fairly clear path towards commercialization,” says Maurer. “In our application we stated that SiO2 would be commercializing new labware in the first part of 2016, and we successfully introduced our first two microplates (96- and 384-well plates) in March 2016. Wheaton is SiO2’s commercial partner for bringing ultra-low binding and ultra-clean products to the labware market, and Wheaton joined SiO2 in San Diego. More specifically, Wheaton announced the launch of AntiBINDTM microplates which virtually eliminates non-specific protein binding,” he adds.

“I had mentioned to the SLAS2016 SIG that we believe SiO2’s technology could be of utility for storage tube applications. Because of this new connection, I went to Berlin for the SLAS Europe Conference on Compound Management in Industry and Academia,” Maurer notes.

Offering Modularity; Solving Leachability

Reno-based Click Bio also brought a potential solution to the problem of laboratory leaching to SLAS2016.

“SLAS is clearly the place to be in the laboratory automation industry, as evidenced by the record attendance at SLAS2016,” says Craig Vincze, Ph.D., CEO. “All kinds of industries are relying more and more on automation to increase their efficiency, whether in pharmaceuticals, biotech, food science, cosmetics, forensics or veterinary. The heads of industries represented at SLAS have big dreams and lofty goals, and need to release life-saving experimental results and drugs to the market as quickly as possible. There were over 6,000 people at SLAS2016, and we talked to hundreds of them,” he adds.

Although the company is only two years old, Vincze and fellow Click Bio cofounder Mykle Gaynor have been involved with SLAS for over a decade.

“We collaborate with major liquid handling companies, such as Beckman Coulter, Hamilton Company and Tecan, who are stalwarts at SLAS, and have been there from beginning,” he says.

Being involved with SLAS paid off for Vincze and the company this year with a slot on SLAS2016 Innovation AveNEW.

“The criteria for participation, as we understood it, was an innovative new product that solves a significant industry problem,” he says. “What we saw in the market was a lot of innovation on the instrument level, but not on the consumable level.”

“Collaboration is the culture of SLAS and everyone who is a part of it. It’s where the idea for our first product – FlexTrough – came from in the first place,” says Vincze. “What we’ve learned is that people have changing needs, and that’s what led to the modular concept of FlexTrough.”

Click Bio’s modular 35ml, 55ml and 75ml reservoirs can be rearranged on the fly into over a hundred configurations,” says Vincze. “It is designed to work equally well with all liquid handling tools, such as multi-probe heads or independent channels. Re-arrangement can be done in seconds, and the device can be robotically manipulated.”

Click Bio’s FlexTrough product offers features designed to address the problem of leaching, according to Vincze. “All of our products are made out of virgin medical grade polypropylene. We found that a chemical coating can leach off and give bad results. For low dead volumes, the sides are polished in a way that makes them repel water, and the bottom is polished in a way that makes it attract water. Those are just a few of the ways that we make sure the researchers protect the investment in the liquids they’re putting into our container,” he explains.

Not only did the new company enjoy a spot on SLAS2016 Innovation AveNEW, but also it appears that Click Bio’s involvement in SLAS will continue to pay dividends into the future.

“Through collaboration with end users we met at SLAS, we are launching a sterile version of our product this quarter, and we will make a FlexTrough that is compatible with 384-well plates in the fourth quarter of this year,” Vincze adds.

SLAS Innovation AveNEW: Translational Thoroughfare 

Every year, SLAS selects up to eight companies to take part in Innovation AveNEW. Those companies that apply to participate are reviewed by a panel of judges based on technical merit and commercial feasibility, as well as their business plan, the strength of their management team and other characteristics. Selected companies receive complimentary exhibit space, travel and lodging, as well as the opportunity to present their elevator pitch at Late Night with LRIG.

“LRIG invites participants with a new idea, and gives them 10 minutes max, including Q&A, to give an elevator pitch and two or three slides,” explains El-Hage.

Innovation AveNEW participants also often are given the opportunity to engage in workshops like the SLAS2016 half-day seminar “Discovering Your Value Proposition” or one-on-one sessions with experienced professionals who provide entrepreneurial consulting. Corresponding with the record attendance at SLAS2016, the number of applicants for Innovation AveNEW nearly doubled this year.       

In addition to SiO2 and Click Bio, six additional companies were featured on SLAS2016 Innovation AveNEW.

Adeptrix Corporation (Beverly, MA, U.S.)
Adeptrix introduced BAMS™ (Bead-Assisted Mass Spectrometry), a new tool for proteomics that combines bead-based multiplex affinity extraction with the power of mass spectrometry. BAMS applications include affinity separations, enzymatic activity, peptide-protein interactions, low abundance protein determination and small molecule drug discovery. The BAMS platform provides better selectivity, specificity and limits of detection than conventional high-throughput screening methods.

Dispendix (Stuttgart, Germany)
With I-DOT (immediate drop on demand technology), Dispendix offers an innovative liquid handling technology for non-contact nanodispensing. Liquid samples are dispensed directly out of a microtiter plate in a range from two nanoliters up to several microliters for applications such as diagnostic biomarker discovery, high-throughput screening, cell-based assays, cell dispensing, molecular assays and sample preparation.

Elemental Machines (Cambridge, MA, U.S.)
This company’s intuitive web-based software product offers data-driven visualizations and dashboards of the test environment, highlighting factors affecting outcomes so that external influences can be identified and eliminated. The challenge of reproducibility affects virtually every research project and costs scientists precious time, money and resources. Often the culprit is something that was outside the scope of the experiment that wasn’t recorded, and Insights helps researchers and laboratory staffs identify these factors to improve reproducibility and accelerate the pace of discovery.

Meniscense LLC (Bolton, MA, U.S.)
Meniscense develops technology to measure the volume of liquid samples in microplates for liquid handler validation and process quality control in the life sciences. Its patent pending technology harnesses optical interferometry to provide a non-contact, non-destructive, high resolution and high dynamic range measurement of the volume in each well.

Omega Biosystems, Inc.  (Westwood, CA, U.S.)
Omega Biosystems manufactures and sells high-throughput imaging flow cytometers for use by the research, drug discovery and clinical diagnostics industries. Their first product, the Vulcan imaging flow cytometer, adds multi-spectral imaging capabilities to a flow cytometer, enabling users to perform high-content screening, rare cell detection and image-based assays with ease on a familiar flow cytometry platform.

PAIA Biotech GmbH (Cologne, Germany)
This company offers assays for the rapid quantification of antibodies and proteins based on its new proprietary assay technology. Bead-based immunoassays are performed in special 384-well microplates with a drastically simplified workflow. The assays are amenable to automation and run on standard plate readers or fluorescence microscopes. PAIA Biotech focuses on products for screening applications with limited sample volume and high-throughput requirements, e.g. in early cell line development.

 

Applications for SLAS2017 Innovation AveNEW are due Oct. 14. SLAS2017 will be held Feb. 4-8 in Washington, DC.

July 11, 2016