Eyes on screen! Better biological tools sought

November 11, 2009 – 4:03 pm by Michael Christel

If you’re a technology company specializing in high throughput screening and characterization of protein-based drugs, chances are the FDA wants to hear from you. Just call it part of the agency’s fact-finding mission. With biotech pursuits rapidly becoming a go-to option in mainstream drug development, FDA, like most in the industry, is intrigued at the prospects and eager to establish more precise and speedier methods to characterize the safety and efficacy of potentially groundbreaking biologics.

“The FDA realizes that this is the fastest-growing segment, so they’ve been very concerned about how to get quality control standards in place to manage it,� Kevin Hrusovsky, CEO of Caliper Life Sciences Inc., told me. “In the area of biologicals, everyone has been saying you really can’t do that because there’s no analytical tool that would allow you to run the tests in a high throughput way to be able to get those results. It would take you years based on the tools that are out there today.�

But a little education can go a long way, the FDA is discovering. Caliper has its own patented high throughput screening platform for biologics called the LabChip GX, one Mr. Hrusovsky says allows customers to run millions of tests simultaneously on a single system rather than hundreds afforded by traditional tools.

“One day, I called the FDA up and just said, ‘Hey, are you aware of our GX technology and how it’s really helping customers do what it is you’re asking them to do?â€� Mr. Hrusovsky says. “They kind of were unaware and were like, ‘Wow, we gotta learn more about this.’”

So one thing led to another. Caliper and FDA set up a meeting for late last month, where examiners were briefed on the company’s microfluidic lab-on-a-chip technology. Caliper’s chips contain a network of miniaturized, microfabricated channels which have little pipes inside of them – smaller than a human hair – through which fluids and chemicals are moved to perform experiments.

Instead of demonstrating the technology to FDA on its own, Caliper brought out the big guns. The company invited pharma customers Pfizer, Amgen, and Biogen Idec to present their quality-by-design data that they’ve amassed using the microfluidics technology.

According to Mr. Hrusovsky, Amgen scientists said the LabChip GX allows them to conduct high throughput tests 70 times faster than conventional capillary electrophoresis. Pfizer researchers made note of the better data resolution generated compared to traditional methods and Biogen said the technology enables experiments to be performed in one afternoon that historically would take over a month to do using capillary electrophoresis.

“It’s more precise as well as being faster,� Mr. Hrusovsky says. “Sometimes there’s side effects that they can’t really explain because today’s analytical tools aren’t showing that there’s certain bad things there. Whereas ours is so precise, and has such a high sensitivity, that it’s able to show things that you couldn’t even see in the traditional way of doing it.�

Such visibility tools should bode well in the vaccines arena as well, particularly as drugmakers find it difficult to produce enough vaccine to keep pace with the H1N1 pandemic. According to Mr. Hrusovsky, amid news of swine flu vaccine shortages (although GSK’s candidate was approved yesterday joining vaccines made by AstraZeneca, CSL Ltd., Novartis, and Sanofi-Aventis) and the documented challenges in producing these vaccines, Caliper has started to get significantly more involved and discovered that several companies have begun using its LabChip GX platform to screen vaccines as well.

“One of the things we’ve learned is that these vaccine processes are very archaic,� Mr. Hrusovsky told me. “What they create sometimes is not what they want to create. [Companies] have to get control of these processes so that they can be more predictable, and that would lead to them not having so much of a shortage. We think our GX can play a very major role in vaccines to help the bottleneck with a lot of these challenges that exist, and can be used to help discover new vaccines.�

Mr. Hrusovsky notes that several manufacturers still produce vaccines in chicken eggs. Scientists typically inject the virus seed into a chicken egg, break the egg open, and then sift out the egg white, which is where the virus sits. They then screen to determine what other substances might be present besides the virus.

“Many times, a lot of what is in the egg white stays, but they don’t want that to be part of what gets put into the vial,� Mr. Hrusovsky says. “They’ll run our tests to make sure what they have is ‘good purity,’ meaning that it’s just the virus itself and nothing else. Because those other things can be bad things that affect the patient once you give them the vaccine.�

Caliper released its third quarter 2009 earnings Monday. The company said it shipped a record 35 LabChip GX instruments during the period and surpassed 100 installed GX units since the technology was launched a little more than a year ago.

Tags: biologics, Caliper, FDA, microfluidics