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Diamond Taq® polymerases

Most applications nowadays require DNA polymerases with the highest quality standards in terms of purity and production processes.

Enzymes of the Diamond Taq® family meet these requirements by being produced according to cGMP compliant processes, ensuring the highest reproducibility, consistency and sensitivity in every PCR applications.

These enzymes have been validated worldwide by several reference laboratories and major diagnostic companies. 

cGMP Polymerases Benefits

  • Higher lot-to-lot consistency
      > Strickly monitored cGMP and analytical processes ensuring lot-to-lot consistency.

  • Ultra-low bioburden
      > Production in a GMP-Pharma facility leading to a guaranteed bioburden between 0 and 10 CFU/ml.

  • Ultra-low residual DNA content
      > QC-tested ensuring less than 1 fg (0.2 copy) of genomic E. coli DNA / Taq unit.

  • Higher Sensitivity

  • Lower risk of false positive results due to residual DNA contamination (bacterial & fungal)

 

Enzyme production process

Diamond Taq® polymerases manufacturing processes are performed under controlled conditions; in class 10 000 cleanroom for purification (ISO 7 with < 100 cfu/m³) and in class 100 laminar flow hoods for fill & finish (ISO 5 in with < 1 cfu/m³).

Quality system

The Quality Management System is fully compliant to the ISO13485:2003 Medical Device standard and FDA’s Quality System Regulations (21 CFR 820).

Final product is released by our Quality Assurance Department with a formal Certificate of Analysis. Full batch records are maintained and can be reviewed during customer or regulatory audits.


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