The challenges and solutions for the bioanalysis industry were
top of the agenda for last week's exclusive bioanalysis
seminar organised by Quotient Bioresearch in Munich, Germany.
The seminar was attended by representatives from
pharmaceutical and biotechnology organisations across Europe
and featured debates and panel discussions from leading industry speakers on new
techniques and hot topics including the latest industry guidelines.
Richard Houghton, Principal Scientist for Bioanalytical
Sciences at Quotient Bioresearch, opened the seminar with a discussion on the
validation of DBS methods for use in regulated bioanalysis. He highlighted the
advantages and disadvantages of DBS and talked about the relevant regulatory
considerations addressing several specific issues including blood spot volume
and haematocrit assessment.
"Interest in the use of DBS continues but harmonisation in
the approach to validation of method is required," explained Richard. "There is
a real concern that the regulatory authorities will not accept the data and the
European Bioanalytical Forum (EBF) is bringing together a topic team to discuss
how to take the technique forward."
The
seminar also featured a senior level speaker from a leading pharmaceutical
company who is actively involved in the EBF and led a very interesting
discussion of new and emerging guidelines for method validation. Other
contributors included Sigma-Aldrich, looking at mobile phase considerations for
analysis of peptides and proteins with LC-MS and Waters, focusing on the
application of an integrated microfluidic device for the high sensitivity
analysis of pharmaceutical and endogenous compounds in biological fluids.
Richard added: "The debates and discussions which took
place at the seminar and the level of interaction from the delegates were far
better than we anticipated and resulted in a very valuable seminar for all
those who attended.
"This is the first seminar we have hosted in mainland Europe and from the response we're already making plans
for another."
Quotient's next seminar will be held at the Fordham, Cambridgeshire, UK site on 5th October 2011, further
details will be available on the website soon.
For
further information about Quotient Bioresearch Ltd. visit the website at
www.quotientbioresearch.com/bioanalytical-sciences or for copies of the seminar presentations email
info@quotientbioresearch.com.
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