{ "ProductData": { "ID": "", "ProductType": "Others", "BrandName": "Liberase MNP-S GMP Grade", "ProductNameAddition": "0.2 μm filtered, lyophilizate", "RegulatoryDisclaimer1": null, "DisclaimerGroup1": null, "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": "Blended Proteolytic Enzyme for Tissue Dissociation. For Further Processing only.", "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "Liberase MNP-S GMP Grade" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06297790001_im_en.png", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "510", "StructureNodeStatus": "valid", "NodeName": "Liberase" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "70-044-00", "StructureNodeStatus": "valid", "NodeName": "Proteases" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0134", "StructureNodeStatus": "valid", "NodeName": "Cell Isolation" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0133", "StructureNodeStatus": "valid", "NodeName": "Cell and Gene Therapy" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "NodeID": "01-01-01-07-00", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech and LifeScience" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0014", "StructureNodeStatus": "valid", "NodeName": "Enzymes" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "330-00", "StructureNodeStatus": "valid", "NodeName": "Tissue Dissociation" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "520", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "180-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0008", "StructureNodeStatus": "valid", "NodeName": "Biologics" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "06297790001", "MaterialDescription": "Liberase MNP-S 5mg GMP", "RegisteredProductName": "Liberase MNP-S GMP Grade", "GTIN": "07613336132067", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "5 mg", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "Will be supplied as \"Liberase MNP-S GMP Grade\". Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "", "BrandName": "Residual Protein Liberase Kit", "ProductNameAddition": "ELISA kit for determination of Liberase", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0133", "StructureGroupPath": "CustomBiotech->Cell and Gene Therapy", "StructureGroupName": "Cell and Gene Therapy", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Organization", "NameofStructureSystem": "Organization", "StructureNodeID": "01-01-01-07-00", "StructureGroupPath": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureGroupName": "CustomBiotech and LifeScience", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "10-00-00", "StructureGroupPath": "Impurity Testing", "StructureGroupName": "Impurity Testing", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "20-00-00", "StructureGroupPath": "Residual Testing", "StructureGroupName": "Residual Testing", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "999", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0112", "StructureGroupPath": "CustomBiotech->Protease Portfolio", "StructureGroupName": "Protease Portfolio", "StructureNodeStatus": "valid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "CB - Order Information", "Value": "Will be supplied as \"Liberase MNP-S GMP Grade\". Unit of measure is \"piece\".", "Language": "en", "Country": "XG", "Code": "CB - Order Information" }, { "Name": "Content", "Value": "
1Liberase MNP-S GMP GradeLyophilized enzyme blend Mammalian Tissue Free (MTF) Collagenase I/II and a medium content of Thermolysin MTF.1 vial,
5 mg
", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Safety Information", "Value": "The collagenases are produced by microbial fermentation. The fermentation media are free of any mammalian or avian-derived raw materials. The downstream process is free of any animal derived raw materials, and no animal-derived raw materials are added to the final preparation.
Thermolysin is produced by microbial fermentation. The only animal derived raw materials used in the manufacturing process are:
  • Fish gelatin derived from the skin of wild, deep-sea, cold water, kosher fish species.
  • Fish extract.
The downstream process is free of any animal-derived raw materials, and no animal derived raw materials are added to the final preparation.
Laboratory procedures
  • Handle all samples as if potentially infectious, using safe laboratory procedures. As the sensitivity and titer of potential pathogens in the sample material varies, the operator must optimize pathogen inactivation by the Lysis / Binding Buffer or take appropriate measures, according to local safety regulations.
  • Do not eat, drink or smoke in the laboratory work area.
  • Do not pipette by mouth.
  • Wear protective disposable gloves, laboratory coats and eye protection, when handling samples and kit reagents.
  • Wash hands thoroughly after handling samples and reagents.
Waste handling
  • Discard unused reagents and waste in accordance with country, federal, state, and local regulations.
  • Safety Data Sheets (SDS) are available online on dialog.roche.com, or upon request from the local Roche office.
", "Language": "en", "Country": "XG", "Code": "Safety Information" }, { "Name": "Intended Use", "Value": "Liberase MNP-S GMP Grade is designed for in vitro enzymatic dissociation of segregated tissue, for the isolation of single cells.
  • When the Liberase is intended for cellular and tissue-based product application, the procedure must meet the applicable local laws and regulations, including the involvement of ethic commissions if necessary.
  • Verification of product use for a specific application is the sole responsibility of the applicant.
", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Working Solution", "Value": "
  1. Dilute the reconstituted enzyme with an appropriate tissue dissociation buffer.
    Use the tissue dissociation buffer immediately after reconstitution.
  2. Determine the working concentration for each individual application.
The mass of protein in each vial may vary slightly from lot-to-lot according to the specific activities and assay variability for the enzyme constituents. For lot-specific details, refer to the corresponding Certificate of Analysis.
", "Language": "en", "Country": "XG", "Code": "Working Solution" }, { "Name": "Additional Equipment and Reagent Required", "Value": "
For reconstitution of lyophilizate
  • Sterile, pyrogen-free water
For working solution
  • Tissue dissociation buffer
    Do not add components that may influence enzyme activity, such as albumin, serum, or protease inhibitors.
", "Language": "en", "Country": "XG", "Code": "Additional Equipment and Reagent Required" }, { "Name": "Applications", "Value": "Use Liberase MNP-S, GMP Grade for in vitro enzymatic dissociation of tissue, to isolate single cells from a broad range of tissue types. In particular intended for use in isolation of tissue based stem cells and chondrocytes from cartilage.", "Language": "en", "Country": "XG", "Code": "Applications" }, { "Name": "Positioning", "Value": "Liberase MNP-S is a highly purified enzyme blend for tissue dissociation where high purity, consistent quality, low levels of bacterial endotoxins and a sterile product are required for reproducible high cell yield and viability.", "Language": "en", "Country": "XG", "Code": "Positioning" }, { "Name": "Product Description", "Value": "Liberase MNP-S contains highly purified collagenase class I and class II from Clostridium histolyticum. The two collagenase isoforms are blended in a precise ratio with each other and with a medium concentration of highly purified thermolysin, a neutral protease isolated from Bacillus thermoproteolyticus. The blend is manufactured in accordance with Good Manufacturing Practice (GMP).", "Language": "en", "Country": "XG", "Code": "Product Description" }, { "Name": "Quality Control", "Value": "Liberase MNP-S, GMP Grade contains highly purified collagenase class I and class II from Clostridium histolyticum. The two collagenase isoforms are blended in a precise ratio with each other and with a medium concentration of highly purified thermolysin, a neutral protease isolated from Bacillus thermoproteolyticus.
For lot-specific certificates, see section Contact and Support.", "Language": "en", "Country": "XG", "Code": "Quality Control" }, { "Name": "Benefits", "Value": "
  • Maximum cell yield, viability, and functionality
    Use of high-specific-activity blends with reduced clostripain, trypsin, and endotoxin content maximizes yield of viable, functional cells.
  • Reduced contamination risk
    Manufactured free of any mammalian- or avian-derived raw materials, avoiding the risk of transmission of animal diseases.
  • High experimental reproducibility
    High lot-to-lot consistency due to optimized enzyme fermentation and purification processes results in increased experimental reproducibility, ultimately saving time and resources.
  • Flexible enzyme portfolio
    Custom sizes and blends are available upon request to better serve your unique application needs.
  • Specific residual assay
    Highly sensitive assay developed specifically for detection of Liberase enzyme verifies removal from your final product.
", "Language": "en", "Country": "XG", "Code": "Benefits" }, { "Name": "Specification", "Value": "Appearance: White lyophilized cake
Total protein (Mass/bottle): 5.5-8.3 mg (target: 6.9 mg protein)
Collagenase I b, c part of collagenase I: ≤40 %area
Collagenase I content: 2.2-3.4 mg (target: 2.8 mg protein)
Collagenase II content: 1.5-2.3 mg/bottle (target: 1.9 mg protein)
Neutral Protease content: 1.8-2.6 mg (target 2.2 mg)
Activity (Wünsch, calculated): 19-32 U/bottle
Activity (Neutral Protease, calculated): 19,140 - 37,000 U/bottle
Ratio Collagenase II/Total Collagenase (HPLC): 0.3-0.5
Endotoxin: ≤15 EU/mg protein", "Language": "en", "Country": "XG", "Code": "Specification" } ] } } ] }

Liberase MNP-S GMP Grade

0.2 μm filtered, lyophilizate