News, posts and stories about life science related topics from ETH and around the world

Bio-Alumni-Exkursion zu MSD Werthenstein BioPharma: Besuch des neuen forensischen Labors zur Untersuchung gefälschter Medikamente

Medikamentensicherheit spielt eine entscheidende Rolle. MSD (Merck Sharp & Dohme) stellt eine breite Palette an verschreibungspflichtigen Medikamenten her. Die Unversehrtheit der Arzneimittel ist dabei das höchste Gut zum Schutze der Patienten und ihrer Gesundheit.

Leider wird genau dies verstärkt zur Zielscheibe verschiedener Fälscherbanden. Medikamente werden manipuliert, gefälscht oder deren Verpackung verändert. Dies alles stellt eine  gefährliche bis lebensbedrohliche Situation für die Patienten dar. MSD hat deshalb vor einem Jahr in ihrer Schweizer Niederlassung Werthenstein BioPharma im luzernischen Schachen ein forensisches Labor eingerichtet, das auf die Untersuchung gefälschter Medikamente spezialisiert ist. Dieses Labor ist eines von weltweit drei forensischen Laboratorien dieses global tätigen biopharmazeutischen Konzerns mit Hauptsitz in New Jersey, USA, und beaufsichtigt die Entwicklungen in Europa, im Mittleren Osten und Afrika.

Am 14. Mai 2019 durfte eine Gruppe von 21 ETH Bio-Alumni dieses Labor besuchen und sich über Methoden und Einrichtungen, mit denen mutmasslich gefälschte Produkte untersucht werden, orientieren lassen. Die Führung bestand aus einem Übersichtsreferat in Englisch und einem anschliessenden Laborrundgang.

Das Labor wird von drei spezialisierten Wissenschafterinnen betrieben. Bei der Untersuchung eines verdächtigen Medikaments wird sozusagen „von aussen nach innen“ vorgegangen. Als erstes wird die Verpackung gescannt: Dabei können Abweichungen vom Original im Material oder in der Grösse und Farbe der Beschriftung erkannt werden, die von blossem Auge nicht sichtbar sind. Nächste Stufe ist die Analyse von Tabletten oder Lösungen: Grösse, Farbe, Löslichkeit, Schmelzpunkt, Fluoreszenz u.a. werden mit dem Original verglichen. Schliesslich kommen die Methoden der biochemischen Analytik zum Einsatz: z.B. verschiedene optische Spektroskopien, Massenspektrometrie für die Analyse komplexer Gemische in Verbindung mit Gas- oder Flüssigchromatographie.

Ist ein Medikament als Fälschung entlarvt, muss die Charge aus dem Verkehr gezogen werden. Die Messdaten dienen auch als Beweis bei einer Strafverfolgung. Nach diesem sehr interessanten Einblick in ein Spezialgebiet diskutierten MSD-Spezialistinnen und Besucher vor der Heimreise noch bei einem Apéro über die Wichtigkeit der Sicherheit von Originalpräparaten und wie man den Pfuschern und Fälschern das Handwerk legen kann. Nochmals ganz herzlichen Dank an Dr. Stephanie Mössner und Belen Gonzalez Amoros!

With Patent Suit, Illumina Looks to Tame Emerging British Rival Oxford Nanopore

Gene-sequencing giant Illumina is like the Standard Oil of the genome age. Except instead of oil it pumps DNA.

More than 90 percent of all DNA data is generated by machines Illumina sells, and the San Diego company wants to keep it that way.

Read the full article at MIT Technology review

 

 

 

D-BIOL Newsletter

Download the latest newsletter of the Biology Department  and read about what happened at D-BIOL in 2015 and what the new year is going to bring.

NewsletterDecember2015

Interview with Tony Keserue, founder of rqmicro

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ImageThis interview was conducted by Sunnie Groeneveld and appeared originally on the ETH Founders Community. Follow Sunnie on Twitter @sunniejaye

Sunnie: What does your company rqmicro do?

Tony: We develop solutions for rapid detection of pathogenic microorganisms in water and food. For example, we developed a test for Legionella, a water pathogen that you might inhale when you are exposed to aerosols from air conditioning and that can cause pneumonia. The standard legal test takes ten to fourteen days. Our test takes just one hour and includes the analysis of viability.

 Sunnie: Where do you stand with rqmicro in terms of commercialization?

Tony: We have a working prototype and currently offer the testing methodology as an in house service. So clients send in samples, we run the tests and report them the results. These are clients that have to solve a problem and need results quickly; i.e. they have a contaminated cooling tower, they are dumping a lot of chlorine inside it and have to know to what extent they are reducing the pathogens. If they receive the results in 10-14 days through the standard procedure, the results are useless. This is where our competitive advantage comes in: our turnaround time is just one hour.

Sunnie: How does your test work? 

We translated the manual lab method into an automated process and, therefore, created a microfluidic cartridge that works with a benchtop device. Basically, we purify the target organisms out of the competing flora in a water sample, by tagging the target organisms with magnetic nanoparticles. By using a magnet we can pull these target organisms out of the rest, i.e. the dirt and whatever else is in the sample. Then we count the target organisms optically, which is interesting because we do this on a single cell level. So we do not count the total fluorescence or the DNA content but rather every single cell. In this way, you get totally different high resolution data.

Sunnie: How did you get involved with this specific field?

Tony: I began working on this topic for my master thesis. I studied molecular biotechnology and I did not want to work for the pharmaceutics industry, so I did my master thesis at Eawag, the aquatic research institute of the ETH domain. There the topic was to develop rapid tests for pathogens by flow cytometry. Since I have a molecular background, we brought some molecular approaches to the conservative field of water testing where not much has changed since Pasteur and Koch. That’s about a hundred years ago, so it’s about time to come up with more sophisticated methods. 

Sunnie: Who else is working with you on rqmicro? 

Tony: Our team consists of a system engineer, who is in charge of the micro fluidic and system integration of the instrument. Then we also have a food biotechnologist who is currently working on developing the food tests – something I am very excited about. We’re currently strong in water testing due to my background. But we are pushing to enter the food market because time to result is more important, due to the products low-shelf life and the logistical challenges of food producers.

Sunnie: What is your main target market?

Tony: Food and water. With food, our test is relevant during the production cycle and with water it is mainly to address industrial and environmental issues.

Sunnie: What is one of the biggest challenges you are currently facing?

Tony: The challenge with our company I think is the complexity and the interdisciplinary nature of what we do. We need to understand several fields of study and also have market expertise in two different markets. In certain areas, I know it would be a lot better to hire a person but we don’t have the money to hire someone for every discipline right now. On the client side, the confidence in a new test is initially not very high, so our team has to be extra attentive to delivering great results at a high speed. We get it done, but everyone is wearing at least five hats.

Sunnie: What motivates you? 

Tony: A lot of my personal motivation stems from the fact that I cannot see myself working as a small wheel in some bureaucratic structure doing a lot of documentation and regulatory stuff. As drinking water microbiologist that is, however, what your typical job looks like because it consists largely of quality control tasks. I love to create and build things and see them work, so that’s why I am devoting all my time and energy to rqmicro.

Sunnie: So was it always clear that you would start your own company after completing your degree?

Tony: Absolutely.

 Sunnie: What are your future plans for rqmicro?

Tony: In terms of potential, the market need is very large. So we are facing a large and very international market and have a first-mover advantage. I believe that when traction hits us, the take-off will be anywhere between decent to exploding. I could very well imagine that we will be eventually bought up by a larger company who will integrate us in their structure. I mean, at this point if just one big company like Nestle would start using our technology, we’d explode. That would be a huge, huge success for us.

Sunnie: Are you currently looking for funding?

Tony: We are pursuing an opportunistic approach at the moment. We don’t need a lot of money urgently right now, but of course we could use it to pursue a more aggressive growth strategy. So we are currently meeting VCs, but the more probable scenario is to take some money from business angels and build the first series, then sell it and show some organic growth before raising a larger round.

Sunnie: Last question. How would you describe rqmicro in three words?

Tony: That’s hard. For instance, rqmicro stands for rapid and quantitative microbiology. Or maybe the more accurate answer would be: “It’s my life.”

Found: A gene that prevents Elephants from getting cancer

Logically, elephants should get cancer much more than humans do—elephants have 100 times more cells than we do and live just about as long, providing ample opportunity for cancer-causing mutations to occur. But in fact they have less cancer and now, two teams of scientists have figured out the gene that prevents elephants from getting cancer:

Link to original article in Popular Science