Dornase Alfa Drug Aliquot | DNA in Cystic fibrosis mucus | Therapeutic Enzyme

Aliquoted from the original reference drug | Now available for research use

Aliquots of the reference drug Dornase Alfa are now available as research consumables.

Dornase Alfa drug aliquots can be used for in vitro or in vivo experiments. Several other reference drugs are also available.

The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.

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Pulmozyme® / Dornase Alfa Reference Product

Drug namePulmozyme®
INNDornase Alfa
API typeDornase Alfa is an enzyme produced by recombinant DNA technology.
Pharmacotherapeutic group
Respiratory system
ATC code
R05CB13
TargetDNA in cystic fibrosis mucus
General function
Short descriptionManagement of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and over 5 years of age to improve pulmonary function.
Pharmacodynamic properties
(Mechanism of action; Source EMC document)
Recombinant human DNase is a genetically engineered version of a naturally occurring human enzyme which cleaves extracellular DNA.
Retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent secretions contain very high concentrations of extracellular DNA, a viscous polyanion released by degenerating leukocytes, which accumulate in response to infection. In vitro, dornase alfa hydrolyses DNA in sputum and greatly reduces the viscoelasticity of cystic fibrosis sputum.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMC document)Inhalation studies conducted in rats and non-human primates show a low percentage of dornase alfa systemic absorption, < 15% for rats and < 2% for monkeys. Consistent with the results of these animal studies, dornase alfa administered to patients as an inhaled aerosol shows low systemic exposure.
Absorption of dornase alfa from the gastrointestinal tract following oral administration to rats is negligible.
Original license holder
Marketing authorisation numbers
30289.00.00 (German authorisation number)
Marketing authorisation holder
Roche Pharma AG
Kurbrunnenweg 9, 67480 Edenkoben
Germany
Name of the manufacturer of the biological active substance
Not available
Name and address of the manufacturer(s) responsible for batch releaseNot available
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Sodium Chloride
Calcium Chloride Dihydrate
Water for Injections

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Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.

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