API LYSOZYME hydrochloride is our highest purity pharmaceutical-grade LYSOZYME. Produced from hen egg-white following stringent cGMP (current Good Manufacturing Practice) guidelines, our API LYSOZYME is used globally as the active pharmaceutical ingredient (API) of choice across pharmaceutical, health, and wellness industries.
LYSOZYME is an active part of the natural defence systems of nearly all living organisms. As the first line of defence for humans, LYSOYME exerts its effect as an anti-bacterial, anti-fungal, anti-viral, and anti-inflammatory. This makes an effective API across pharmaceutical, dermatological, and oral care applications.
Taking inspiration from nature, the broad spectrum activities of API LYSOZYME are exploited in product formulations targeting colds, infections, and inflammatory conditions. Pharmaceutical applications of API LYSOZYME range from oral, oromucosal and dental to nasal, and ocular uses.
At Bioseutica® we offer a full range of services, encompassing both technical and applications support. Contact us today to discuss your specific requirements using the form below
Quality
Our manufacturing site adheres to the highest quality standards and has implemented a Quality Management System fully compliant with cGMP guidelines for the production of APIs. This ensures the highest of quality for our API LYSOZYME hydrochloride. Our site is periodically inspected by the Dutch Health Authorities, further ensuring full cGMP compliance.
Bioseutica’s API LYSOZYME hydrochloride is ‘Solvent Free’: No solvents are used at any stage of the manufacturing process.
Regulatory
Our API Lysozyme hydrochloride is fully supported by an Active Substance Master File / Drug Master File, in compliance with the CTD (Common Technical Document) format, internationally accepted by the ICH regulatory authorities.
Prompt regulatory support is provided to all of our customers by our Regulatory Affairs team, having extensive experience with medicinal product approval procedures. This enables our customers to gain faster approval of their medicinal products, reducing the time to market. Our Regulatory Affairs team is ready to support you throughout your product lifecycle.
- Advanced manufacturing process (cGMP).
- Selling Unit: Kilograms (Kg)
References
- Ferraboschi, P.; Ciceri, S.; Grisenti, P. Applications of Lysozyme, an Innate Immune Defense Factor, as an Alternative Antibiotic | Publisher Site
- Takada K et al.: Detoxification of lipopolysaccharide (LPS) by egg white lysozyme | Publisher Site
- Tagashira A. et al.: Lysozyme from hen egg white ameliorates lipopolysaccharide-induced systemic inflammation in mice | Publisher Site
- Derde M et al.: Hen Egg White Lysozyme Permeabilizes Escherichia coli Outer and Inner Membranes | Publisher Site
- Derde M et al.: Native lysozyme and dry-heated lysozyme interactions with membrane lipid monolayers: Lateral reorganization of LPS monolayer, model of the Escherichia coli outer membrane | Publisher Site
- Ferrari R.: Antiviral activity of Lysozyme Nature 1959 | Publisher Site
- Lee-Huang S et al.: Lysozyme and RNases as anti-HIV components in beta-core preparations of human chorionic gonadotropin | Publisher Site
- Malaczewska et al.: Antiviral effects of nisin, lysozyme, lactoferrin and their mixtures against bovine viral diarrhoea virus | Publisher Site
- Fukai et al.: New possibilities for egg white lysozyme: heat-denatured lysozyme partially inactivates select foot-and-mouth virus strains | Publisher Site
- Sebaa S. et al.: Dose-dependent effect of lysozyme upon Candida albicans biofilm | Publisher Site
- Samaranayake Y et al.: Antifungal Effects of Lysozyme and Lactoferrin against Genetically Similar, Sequential Candida albicans Isolates from a Human Immunodeficiency Virus-Infected Southern Chinese Cohort | Publisher Site
- Dai, P.; Li, Q.: Lysozyme : Research progress in the application of lysozyme in food and medicine field - A review | Publisher Site
API Lysozyme embodies three main biological activities which are of significance to human health. These include antibacterial action, antiviral action and modulation of the immune response.
The antibacterial effects of Lysozyme are achieved through destabilization and degradation of the bacterial cell wall, while the antiviral activities have been attributed to interference with synctia formation and binding of viral nucleic acids. The antiinflammatory and immune potentiating properties of lysozyme have been well documented, however the mode of action is complex and has not yet been fully elucidated.
Bioseutica is the first company in the world to have a DRUG MASTER FILE for the use of API Lysozyme in pharmaceutical applications.
Oral Lysozyme acts directly in the oral cavity or gastrointestinal tract to impede the growth and colonization of pathogenic bacteria.
Oral Lysozyme also works indirectly through interactions with immune inductive sites of the gastrointestinal tract and systemic components of the immune system. The result is an immune modulating effect that is beneficial in a range of health afflictions where the immune system is in a depressed or imbalanced state.
Topical Lysozyme acts locally at the site of tissue damage to control microbial dissemination and inflammation. These activities combine to speed the reparative process of damaged skin.