"A short bioanalytical feasibility is the most efficient way preparing optimally for first in-vivo studies" was the message of the presentation given by Christian Kikuta and Martin van Dam.
The afternoon was dedicated to the subject "Preparing for 1st In-Man / Preclinical Strategies", organized by LISA, the Austrian life science cluster organization.

In the early phase of developing a compound obviously the bioanalytical behavior is vastly unknown. Yet the upcoming TOX or Dose Range Finding Study want to be planned optimally, in the light of the large lumps of budget absorbed by them.

A bioanalytical feasibility is a 2-4 day ballpark investigation of the bioanalytical behavior in plasma (or respective matrices). Output are rudimentary data on: stability in plasma, detectability, linearity, rough limits of detection and selectivity.

In combination with a pilot pre-clinical study administering the compound to 2-3 rodents, even important first information on bioavailibility can be gained, such as first-pass-effect, metabolism or protein binding.

The benefits are obvious:
- Reduction of Risk and disclosing latent "bad news"
- Estimation of effort and cost for upcoming in vivo trials
- Knowing scope of data to expect of pre-clinics
- Improved position towards VCs and authorities

In context with in-vivo pilot study:
- Pre-conclustions on administrative route
- Impression of bioavailibility / metabolism
- Orientation for dose range

Summary: Cut Risk and Cost with Preliminary Data.

Starting with September 2012 pharm-analyt´s head of QA/QM, Timo Kretzschmar, will be lecturing “QM Systems in Biotech and Pharmacy” at Campus Tulln (FH Wiener Neustadt).

Dr. Kretzschmar is a remarkable expert in quality management in context of pharma and Life Science. He has an intriguing mix of knowledge, experience and excitement for his subjects GLP and GMP.
His record of lecturing on academic level goes back to 2004.

One of the focal points of the upcoming 3rd Focus Meeting in Brussels June 12-13 will be the topic of tissue analysis.

We´re all familiar with the main challenges of quantifying a substance from tissue material:
- Selecting a representative section (especially with large organs)
- Sample preparation / homogenization
- Recovery
- Matrix effects

Hermann will draw from his long standing experience in preparation of various types of biological tissue and successful analysis with HPLC-MS/MS.

Some of it, by the way, is laid out in his book "HPLC Methods for Clinical Pharmaceutical Analysis".

Meet us at BIO International Convention in Boston June 18-21!

pharm-analyt will be represented at the Austrian booth (No. 3265).

We are looking forward to seeing you in Boston!

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!