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Eric Bishop, MedImmune, Gaithersburg, USA, speaks candidly about some of the challenges facing his industry and how Gyrolab is helping MedImmune overcome these hurdles

What are the major challenges facing the pharmaceutical industry today?
I think, as a general rule of thumb, a lot of companies are trying to work more efficiently and running
very lean.

How do you think Gyrolab can contribute to overcoming some of these challenges?
What really helps is improving the turnaround time for process-related impurity testing. The faster we can get samples processed, the quicker we can make critical process decisions. Any time that we can shave off the process is very beneficial, and with Gyrolab, we are able to take our throughput from about five or six samples per day up to about 80 samples per day.

What are the main application areas you are working in today?
Currently, we do a lot of process related impurity testing.

What are your key challenges within these application areas?
It's essentially throughput. We have so many samples and a limited number of people to test them. We could devote all the resources that we have to testing samples, or we could allocate them to other tasks, if we used an automated system to analyze the samples - Gyrolab was the natural choice in that situation.

So how does Gyrolab compare with conventional technologies for these applications?
There's no comparison! The conventional assay is a 96-well format ELISA, and on a typical ELISA plate you can only test between two to six samples in total - and one analyst can only process one or two plates a day. So it's a very slow and laborious task.

Also, because ELISA uses colorimetric detection, there is a very limited dynamic range. With Gyrolab, there is the added advantage of fluorescence, which provides a much broader dynamic range. This equates to a lot less sample repeats.

How would you rate Gyros' application and customer support services?
So far they have been outstanding. Typically, when we place a call, someone arrives by the next day.

Was productivity the main reason for purchasing Gyrolab?
The major advantages are reduced reagent consumption and high throughput. We develop and qualify the reagents that are used in our immunoassays. These reagents are very precious - so if we can use five microlitres of a reagent, instead of 200 microlitres, it's obviously a major benefit. After working with the system and realizing how easy it is to develop assays, we realized how much we could increase our throughput and simplify sample preparation - Gyrolab delivered major benefits.

Dr. Matthias Kania, project leader at Rentschler Biotechnologie,
Laupheim, Germany

"We are a CMO, so our focus is to keep our clients satisfied so that, of course, means being on time to market. We want to meet their deadlines and help them reach their milestones, so that means that we need fast and reliable technologies. It's also important to have state-of-the-art equipment and employ
new technologies so that we maintain an advantage over other competitors."

"Gyrolab is a very fast and reliable technique compared to ELISA. ELISA takes at least one full day and with Gyrolab you can reduce this time significantly: you can have results in one, to one-and-a-half hours. This is a very big advantage for the downstream and upstream development support. This means that we can be much faster, and that's a key aspect that helps us to provide a better service to our clients."

"I would say that in the future we want to replace ELISAs. We want to introduce more automation into our workflow and, of course, it's good for us to be able to add innovative new technologies to our service offering. Our main reason for purchasing Gyrolab was speed: it's completely automated from the point that you have prepared the samples. So you can press the button and you get the results, whereas with ELISA you need to carry out a lot of manual steps to get results."

Johanna Mora, Bristol-Myers Squibb, Princeton, NJ, USA

"There is a high cost associated with bringing a new drug to market. It's important, therefore, to find ways to contain costs, whilst still delivering a safe drug that is effective and will improve the quality of life of patients. To contain costs, the industry is turning to technologies that will facilitate high-throughput screening, while maintaining sensitivity and reproducibility."

"With regard to immunogenicity, one of the things that drives up costs is the generation of a pseudo-positive control. The amount of purified anti-drug antibody generated is very small, so the material is very precious to us and being able to work with small volumes helps contain costs. The small sample and reagent consumption are key benefits of Gyrolab, which help limit costs. For PK and ADA studies, a method that is sensitive and consumes less volume is important."

"Using Gyrolab to detect anti-drug antibodies allows for high-throughput screening. Furthermore, the built-in automation actually gave me more time during the day to focus on other important issues."

Dr. Volker Sandig, VP Cell & Vector Biology at ProBioGen in Berlin, Germany

"As a contract manufacturing provider, the Gyrolab system provides us with an extremely efficient method for quantitative analyses of IgG and therapeutic proteins with less hands-on time. The very high accuracy of measurement will greatly enhance our offering to our clients."

Lily Chu, Associate Scientist, Biotech company, CA, USA

"Because we are in process development, high throughput is very important for us. In terms of the number of samples we receive and how much time we need to spend per test, that costs money! We are under pressure to conduct more and more tests."

"We are using the full potential of Gyrolab to develop new assays quickly; perform a lot of different analyses of the same sample in parallel; and process a lot of samples at the same time. We try to fit many different experiments into one big batch run. We ultimately chose Gyrolab because it uses much less material and is much faster."

"Other technologies require large sample volumes, but not Gyrolab. And the design is so cool!"

Brian Kleber, COO at PPM: Predictive Physiology & Medicine Inc.,
Bloomington, USA

"Gyrolab was the obvious choice for the targeted protein analysis portion of our bioprofiling. The small blood volumes for analysis, automated process, and high throughput were the key dealmakers for us. We want to provide our customers with rapid, robust and accurate results in the least invasive manner possible and Gyrolab fulfills those requirements perfectly. Conventional technology comes nowhere near in terms of productivity and accuracy. Our closest competitor takes two weeks to provide results - we can provide them within two days."

Dr. Anders Hagman, Process Analysis group, AstraZeneca, Södertälje, Sweden

"Compared to other laboratory automation systems, Gyrolab offers a much-simplified way of working. The Gyros team has provided great support in setting up new assays at our lab."