Diagnostic cGMP Taq

Manufacturing of Taq DNA Polymerases for Diagnostics

For more than 20 years, Eurogentec Genomics has been a leading supplier of high quality reagents for genomic research to bench scientists around the globe.

With the expansion of our state-of-the-art cGMP (current Good Manufacturing Practices) facility and our ISO 13485 certifications for production & sales of IVD oligonucleotides in Belgium, USA & Japan, we have significantly increased our capacity for manufacturing cGMP components for DNA- and RNA-based Molecular Diagnostic assays.

In addition, Eurogentec Genomics has joined forces with Eurogentec Biologics, a leader in GMP manufacturing of biopharmaceuticals, to offer a new service: cGMP manufacturing of Taq DNA Polymerases.

Diamond Taq® Selection guide

Diamond Taq® Benefits

	Ultra-low residual DNA content (0.002 E.coli genome copies/Taq Unit).
	Pure, purity higher than 98 % and ultra-low bioburden (< 10 CFU/ml) due to production in a GMP-Pharma facility.
	Exceptional reproducibility, GMP process and stringent QC combined with rigorous analytical method ensure exceptional lot-to-lot & results reproducibility.
	Sensitive, efficiently amplifies DNA templates even at very low concentrations.
	cGMP compliant, the Quality Management System is fully compliant to the ISO13485:2003 Medical Device standard and FDA’s Quality System Regulations (21 CFR 820).
	Complete, PCR reaction buffer & MgCl₂ are included.
	Customized Fill & Finish on request
	Batch reservation on request
	For Diagnostic and demanding Research PCR & qPCR
	Attractive pricing

Quality System

Our Quality Management System is fully compliant with the ISO13485:2003 quality standard and FDA’s QSR (21 CFR 820).

The entire process is performed under controlled conditions; in class 10,000 clean room for purification (ISO 7 with < 100 cfu/m³) and in class 100 laminar flow hoods for fill & finish (5 in with < 1 cfu/m³).

	Utilizing numerous redundant process control checklists to eliminate possible errors at all stages of manufacture
	Incorporating stringent SOPs and change control procedures to ensure rigorous lot-to-lot consistency
	Providing comprehensive and detailed batch record documentation substantiating strict adherence to our partners’ required quality specifications

Customer Care

First and foremost, the Eurogentec diagnostic team believes that knowing its customer needs and expectations is essential to the success of any collaboration. Long-term relationships with our customers are built on trust and mutual respect.