Arqtech Laboratories specialise in providing an assay for the testing of recombinant protein products of the Bio-Pharmaceutical industry for remnant / residual DNA. The assay is a membrane isolation / radiolabelled probe hybridisation based assay. To date we have applied the assay to the detection of bacterial genomic DNA, plasmid DNA and DNA extracted from a mammalian cell line. The protein products assayed vary in presentation, and include lyophilised material in a citrate 'cake' and high and low volume liquids. Upon request, Arqtech Laboratories are willing to investigate the feasability of providing any other service that a customer may require. To this end Arqtech Laboratories maintain a flexible position regarding the nature of the work and conditions under which it is performed in order to facilitate the customers needs.
Assay Specifications
The level of sensitivity routinely achieved is lower than 6 pg in the
case of procaryotic DNA and between 6 and 24 pg 
for
eucaryotic DNA. There is a linear relationship between DNA quantity and
detected signal, ascertained by densitometric analysis. Recovery of DNA
from protein samples stands at between 70% and 110% depending on the system
being assayed.
Service History
Hundreds
of protein samples have been tested. A routine service for three
international bio-pharmaceutical companies is provided, and preliminary
work at various stages is being carried out for several others. For three
of the companies Arqtech Laboratories has completed Laboratory Qualification
and Validation of the assay nescessary for Regulatory approval of their
products. As part of these procedures we have examined assay linearity,
recovery, reproducibility and matrix effects and established Standard Operating
Procedures and Protocols. We can offer a preliminary investigation of individual
products, full scale validation and qualification and an efficent and competitive
routine service.
ARQTECH Laboratories Ltd.,
Unit 5, Kilkerrin Park 3,
Liosbaun Industrial Estate,
Tuam Road,
Galway, Ireland.
E-mail info@arqtech.com
Tel 353 91 771110
Fax 353 91 771464