Several months of well-filled order backlog have led to re-assess our workflow, in order to maintain one of our most valued attributes: FLEXIBILITY.

To our general surprise the greatest demand wasn´t more upscale mass-spec-equipment, but simply lab space. Space for optimized workflow, space for optimized sample preparation, space for experimental, investigational work.

But the generic growth of the recent 25 years certainly had not left much void surface at our site. Considerably much space had been taken up by our archive-domain, space filled over the years with GLP retention documents (especially from times before electronic archiving).

Externalising the archive
External space in the near neighbourhood was adapted to GLP archiving requirements and the entire archive was moved across the road, yielding “new land” at our facility!

The layout of the new lab was diligently designed in regards to workflow, one of them being generous bench spaces, not to mention the additional capacity of lab infrastructure!

Last week the first actual lab-routines were accomplished at the new workplaces, showing immediate positive impact on the workflow!

Everyone is happy, as it seems!

Hermann Mascher describes all steps of a routine pharmaceutical analysis in an intuitive fashion and explains how to develop robust and efficient methods for any clinical compound. A reference appendix contains tried and tested methods and data for 100 frequently encountered pharmaceuticals.

Hermann Mascher was looking for a reference book of common pharmaceuticals including their pharmacokinetic characteristics, unfortunately he never found one. So he decided to write one himself: “HPLC Methods for Clinical Pharmaceutical Analysis”.

In this book the author draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walk-through case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and efficient method for a given substance.


Publisher: WILEY-VCH
ISBN: 978-3-527-33129-1
Hardcover, 240 pages

Looking back, this 25^th year of pharm-analyt was stamped by a significant workload related to anti-asthmatic APIs at accordingly low concentration levels. Examples are Salmeterol (LLOQ 2 pg/mL), Fluticason Propionat (LLOQ 3 pg/mL and even 0,25 pg/mL), Formoterol (LLOQ 0,4 pg/mL) and Budesonid (LLOQ 5 pg/mL) as well as NCIs.

Also determination of β-Blockers with rapid onset of action and concentrations of their respective metabolites in plasma were welcome challenges.

Phyto-substances
In the area of phyto-originated substances from plasma we succeeded to optimize a method by factor 40, which was vital to the process of the sponsor.

Peptides
As to be expected, several projects addressed the analysis of peptides from plasma again. Here I recall the “highlight” being the development of a sensitive method for a peptide with a free Thiol.

PEGylated substances
More and more often we are also confronted with the task of analyzing PEGylated substances from plasma with HPLC-MS/MS. This year we gained even deeper experience with this delivery approach, especially in combination with complex lead molecules with a PEG.

Biomarkers
Together with Prof. Andt Rolfs from Centogene in Rostock we discovered and patented two biomarkers (in plasma) for rare diseases: lysosomal storage diseases. Particular significance is given to the fact, that the markers have 100 % specificity and 100 % sensitivity. So patients can be identified and diagnosed as to the progress of the disease as well as to the response to enzyme therapies.

Publications
Again several project results / conclusions were well worth publishing. So we tried to slide-in some writing work between the busy daily routines, and submitted a couple of publications at renowned journals. Details will follow.

Thank you for another year of good collaboration!

We´re looking forward to a new year spiced with more beautiful bioanalyitcal challenges! Thank you to all of our sponsors and providers for yet another great year of good and exciting collaboration!

May 19^th was the great day, when pharm-analyt celebrated its 25 years of existence together with staff and partners!

In the morning guests were welcomed at the pharm-analyt premises with the opportunity of a guided tour through the lab facilities. The tour took the visitor in process-chronology from sample-arrival, via sample storage, sample preparations to the actual sample analysis. There was a representative amount of daily routine to be observed as plenty of work had to go on. The tour concluded at the buffet in the courtyard, were everyone enjoyed the time of networking in very cheerful atmosphere.

The afternoon program commenced at the nearby Fontana venue, starting with refreshments on the terrace leading on to the sessions.

Prof. Markus Müller gave a highly interesting overview over trends and challenges of pharmaceutical R & D, followed by a musical interlude of “That´s Us”. Hermann Mascher rounded up the sessions by presenting bioanalytical highlights of his 30 years of experience.

The actual celebration dinner was served at the terrace enjoying the great ambience created by the mix of people and the great venue, as the sun went down over the picturesque lakeside scenery.

Thank you to the ones celebrating with us, making it a truly memorable day. Sorry to the ones who were unable to join us. With the photographs posted we hope to give a few impressions of the day.