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Dornase alfa | CAS No: 143831-71-4 | GMP-certified suppliers
A medication that reduces mucus viscosity and improves airway clearance as adjunct therapy in cystic fibrosis respiratory management.
Therapeutic categories
Primary indications
- Used as adjunct therapy in the treatment of cystic fibrosis
Product Snapshot
- Dornase alfa is a respiratory inhalation formulation available primarily as an aerosol and solution
- It is indicated for adjunct therapy in cystic fibrosis treatment
- The product is approved for use in the US and Canadian pharmaceutical markets
Clinical Overview
Clinically, dornase alfa is indicated as an adjunctive therapy for cystic fibrosis (CF), a genetic disorder marked by accumulation of viscous purulent secretions in the airways. These secretions result from high concentrations of extracellular DNA released by degenerating leukocytes during chronic pulmonary inflammation and infection characteristic of CF. By enzymatically hydrolyzing this extracellular DNA, dornase alfa reduces sputum viscosity and viscoelasticity, which can improve mucus clearance and potentially mitigate airflow obstruction. The agent acts selectively on DNA-containing purulent sputum and does not affect healthy or non-purulent mucus.
Pharmacodynamically, the enzyme’s activity depends on divalent cations such as calcium and magnesium. Its mechanism involves endonucleolytic cleavage of extracellular DNA polymers, thereby disrupting the highly viscous anionic matrix contributing to airway obstruction in CF patients. Dornase alfa has no appreciable effect on intracellular DNA, minimizing concerns regarding cytotoxicity related to genomic degradation.
Key ADME parameters are not typically defined for dornase alfa given its local administration via inhalation and enzymatic mode of action confined to the respiratory tract. Safety considerations primarily focus on local tolerability; adverse effects may include voice alteration, pharyngitis, and rash. Systemic toxicity is limited due to minimal systemic absorption.
Dornase alfa is marketed under various brand names globally and is a well-established enzyme therapy within pulmonary care for CF. When sourcing dornase alfa API, manufacturers must ensure compliance with stringent quality standards governing recombinant biologics, including verification of sequence identity, enzymatic activity, purity, and absence of host cell contaminants to guarantee therapeutic consistency and patient safety.
Identification & chemistry
| Generic name | Dornase alfa |
|---|---|
| Molecule type | Biotech |
| CAS | 143831-71-4 |
| UNII | 953A26OA1Y |
| DrugBank ID | DB00003 |
Pharmacology
| Summary | Dornase alfa is a recombinant human DNase I enzyme that hydrolyzes extracellular DNA in purulent sputum, reducing its viscosity and improving airway clearance in cystic fibrosis patients. Its activity targets extracellular DNA released by leukocytes during pulmonary infection and inflammation. This enzymatic degradation of DNA helps alleviate airflow obstruction associated with thick, purulent secretions in the lungs. |
|---|---|
| Mechanism of action | Dornase alfa is a biosynthetic form of human DNase I. The enzyme is involved in endonucleolytic cleavage of extracellular DNA to 5´-phosphodinucleotide and 5´-phosphooligonucleotide end products. It has no effect on intracellular DNA. Optimal activity is dependent on the presence of divalent cations such as calcium and magnesium. Extracellular DNA is a viscous anionic polymer and its breakdown appears to improve the viscosity and viscoelasticity of purulent sputum of individuals with CF, thus reducing airflow obstruction. Dornase alfa does not seem to have any effect on non-purulent sputum. |
| Pharmacodynamics | Cystic fibrosis (CF) is a disease characterized by the retention of viscous purulent secretions in the airways. These thick secretions contribute both to reduced pulmonary function and to frequent pulmonary infection. Purulent pulmonary secretions of individuals with cystic fibrosis contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to these infections. Dornase alfa hydrolyzes the DNA in sputum of CF patients and reduces sputum viscosity and viscoelasticity. The enzyme does not appear to affect sputum in the absence of an inflammatory response to infection, nor does it affect the sputum of healthy individuals. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans |
ADME / PK
| Absorption | Studies in rats and monkeys after inhalation of dornase alfa shows very little systemic absorption (less than 15% for rats and less than 2% for monkeys). The results were also witnessed in patients. Dornase alfa is also associated with very low accumulation with no serum concentration greater than 10ng/mL observed no matter the dose administered. Bioavailability: mean sputum concentrations of dornase alfa can be measured after 15 minutes. Onset is achieved within 3 to 7 days. Peak concentrations are achieved after 9 days. |
|---|---|
| Metabolism | While no conclusive studies have yet been published, dornase alfa is expected to be metabolized by proteases in biofluids. |
| Volume of distribution | In studies in rats and monkeys, the initial volume of distribution is similar to the serum volume. Concentrations in sputum decline rapidly after inhalation. |
| Clearance | Studies in rats indicate that, following aerosol administration, the disappearance half-life of dornase alfa from the lungs is 11 hours. In humans, sputum DNase levels declined below half of those detected immediately post-administration within 2 hours but effects on sputum rheology persisted beyond 12 hours. |
Formulation & handling
- Dornase alfa is a biotech-derived enzyme administered via inhalation, requiring formulation as a sterile aqueous solution or aerosol.
- The proteinaceous nature of dornase alfa necessitates careful handling to maintain enzyme stability and activity, avoiding exposure to extreme temperatures or agitation.
- Formulation should ensure compatibility with nebulizer devices to preserve integrity and deliver consistent dosing to the respiratory tract.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) entered the market in Canada following patent expirations in 2013 and 2015 and is currently marketed in both the US and Canadian markets, reflecting a mature product lifecycle stage. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dornase alfa is primarily manufactured by Genentech, Inc., with several packagers involved in distribution. Its branded products, such as Pulmozyme, are established in the US and Canadian markets. The listed patent expirations suggest limited potential for imminent generic competition in these regions. |
|---|
Safety
| Toxicity | Adverse reactions occur at a frequency of < 1/1000 and are usually mild and transient in nature. Reported adverse effects include chest pain (pleuritic/non-cardiac), fever, dyspepsia, voice alteration (hoarseness), pharyngitis, dyspnea, laryngitis, rhinitis, decreased lung function, rash, urticaria, and conjunctivitis. There is no evidence of carcinogenic or mutagenic properties. The safety of dornase alfa has not been studied in pregnant women, nursing women and children under the age of 5 years old. |
|---|
- Adverse reactions are infrequent (‹1/1000) and generally mild and transient
- Reported toxicities include respiratory and dermatologic effects such as dyspnea, rash, and urticaria
- No carcinogenic or mutagenic potential identified
Dornase alfa is a type of Other enzyme replacements/modifiers
Others
Dornase alfa (Other enzyme replacements/modifiers), classified under Enzyme Replacements/modifiers
Enzyme replacements/modifiers are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the treatment of various enzyme-related disorders. Enzymes play a vital role in the normal functioning of the body by catalyzing specific biochemical reactions. However, in certain medical conditions, the body may lack or produce dysfunctional enzymes, leading to serious health complications.
Enzyme replacement therapy (ERT) involves administering exogenous enzymes to compensate for the enzyme deficiency in patients. These enzymes are typically derived from natural sources or produced using recombinant DNA technology. By introducing these enzymes into the body, they can effectively substitute the missing or defective enzymes, thereby restoring normal metabolic processes.
On the other hand, enzyme modifiers are API substances that regulate the activity of specific enzymes within the body. These modifiers can either enhance or inhibit the enzyme's function, depending on the therapeutic objective. By modulating enzyme activity, these APIs can restore the balance of enzymatic reactions, leading to improved physiological outcomes.
Enzyme replacements/modifiers have shown remarkable success in treating various genetic disorders, such as Gaucher disease, Fabry disease, and lysosomal storage disorders. Additionally, they have demonstrated potential in managing enzyme deficiencies associated with rare diseases and certain types of cancer.
The development and production of enzyme replacements/modifiers involve rigorous research, formulation optimization, and adherence to stringent quality control measures. Pharmaceutical companies invest substantial resources in developing these APIs to ensure their safety, efficacy, and compliance with regulatory standards.
Overall, enzyme replacements/modifiers represent a vital therapeutic category in modern medicine, offering hope and improved quality of life for patients with enzyme-related disorders.
Dornase alfa API manufacturers & distributors
Compare qualified Dornase alfa API suppliers worldwide. We currently have 2 companies offering Dornase alfa API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Bbi Enzymes | Producer | South Africa | South Africa | CEP, CoA | 4 products |
| Sigma-Aldrich | Producer | United States | Unknown | CEP, CoA, FDA | 13 products |
When sending a request, specify which Dornase alfa API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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