Looking back, the last year was a rich year, full of blessings and exciting challenges!

In 2015, a little over half of our work derived from preclinical and clinical bioanalysis for Big Pharma organizations.

But many new projects were added, the majority of those highly innovative Biotech Projects. Often  this very early work has a highly experimental character.
Inhalable drugs have played a significant role again: Analysis at extremely sensitive levels (fg/mL plasma), yet with very low sample volumes (250µL plasma).

Oncology remains a huge topic: Here highly innovative delivery forms are being tried out, but also new drug concepts. Of course these topics require solid assays once in clinical studies.

In 2015 we have invested strongly in our equipment: All HPLC lines were upgraded, most significant was the purchase of another new mass spec line: QTRAP 6500.

We have enjoyed the intensive interactions, the high level discussions and the scouting for solutions of your challenges! May the new year be as exciting!

We are looking forward to yet another year of dialogue and good, long lasting collaborations!

Good success!

Hermann Mascher, CEO pharm-analyt

We are proud and excited to announce, that pharm-analyt has acquired another last generation mass-spec-system QTRAP® 6500 from AB Sciex!

pharm-analyt was nominated for the innovation award “Kreativ in die Zukunft” ("Creatively Into the Future") in the category “Technical Innovation”.

The award is sponsered by the Austrian Economic Chamber.  The final prize will be awarded on June 10^th in St. Pölten.

pharm-analyt discovered and validated specific substances (Small Molecules) in plasma that indicate particular genetic disorders with remarkably high specificity and sensitivity.

Three of these biomarkers were submitted and nominated for this innovation award: For Gaucher’s Disease, Niemann-Pick Type C and Metachromatic Leucodystrophy.
All three have orphan status with an incidence rate of 1:20,000, 1:150,000 and 1:50,000, respectively.

pharm-analyt acquired broad experience and knowledge over the last years in the area of lysosomal storage diseases.

After identifying and validating biomarkers for several lysosomal storage diseases (Gaucher, Fabry, NPC, MLD), pharm-analyt now identified  another biomarker in this field:

A diagnostic marker for Krabbe Disease.

About Krabbe disease (quote from U.S. National Library of Medicine)

Krabbe disease (also called globoid cell leukodystrophy) is a degenerative disorder that affects the nervous system. It is caused by the shortage (deficiency) of an enzyme called galactosylceramidase. This enzyme deficiency impairs the growth and maintenance of myelin, the protective covering around certain nerve cells that ensures the rapid transmission of nerve impulses. Krabbe disease is part of a group of disorders known as leukodystrophies, which result from the loss of myelin (demyelination). This disorder is also characterized by the abnormal presence of globoid cells, which are globe-shaped cells that usually have more than one nucleus.

The symptoms of Krabbe disease usually begin before the age of 1 year (the infantile form). Initial signs and symptoms typically include irritability, muscle weakness, feeding difficulties, episodes of fever without any sign of infection, stiff posture, and slowed mental and physical development. As the disease progresses, muscles continue to weaken, affecting the infant's ability to move, chew, swallow, and breathe. Affected infants also experience vision loss and seizures.

Less commonly, onset of Krabbe disease can occur in childhood, adolescence, or adulthood (late-onset forms). Visual problems and walking difficulties are the most common initial symptoms in this form of the disorder, however, signs and symptoms vary considerably among affected individuals.

Incidence Rate:

In the United States, Krabbe disease affects about 1 in 100,000 individuals. A higher incidence (6 cases per 1,000 people) has been reported in a few isolated communities in Israel.

GMP cleaning validations are a critical part of the manufacturing process of specific galenic formulations.
In order to rule out contamination by potent APIs on working surfaces, highly sensitive analytical methods have to be established.  

pharm-analyt has validated numerous HPLC-MS/MS-methods for various APIs over the last years and has been conducting swab analyses on a continuous basis.  

pharm-analyt has been GMP certified since 2006 and GLP certified since 1992.

Please do not hesitate to contact us in regard to your cleaning validations!

Martin van Dam
Director Business Development
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