Scribd Logo
Upload

Welcome to Scribd!

  • Contract Bio-Manufacturing

    Uploaded by

    davidstoffel123
    5 views1 page
    Use and Sale- Meets Point of Care Use Requirements, Use Pathways; e.g., Licensing, USA Only or International or Both, More than Minimal Manipulation, Living Cells or Derivative, Pre-clinical Testing, IND(s) Clinical Studies, Customers & Markets, Disease Targets, COGS vs. Pricing, Secondary Vendors, Claims & Monitoring. Ship, Store, Shelf Life- Inventory &Tracking, Validated Shippers, GMP CryoMedia, High Recovery, Stability Testing. Procurement- Autologous or Allogeneic Resection vs Other (e.g., Liposuction), Transport Reagents, Methods, Kits, Contracts/Agreements: e.g., ICD; COC; OPO. Processing- Rinsing; Dissociation Counting & Viability, Optional: Culture Cells QC Release: Potency =#+ Bioassays; Identity = biomarker[s]; Safety = endotoxin, sterility, (option) mycoplasma, Further Processing; More Testing. Components Meet GMP and CMC Needs for INDs- Processing & Manufacturing Materials: Only High Quality Materials- Active ingredient (e.g., cells), raw Materials and excipients in final product, Collection, reagents, solutions, cryostorage media, enzymes: made GMP, Bags, centrifuge containers, connectors: qualified vendors. Collection, Processing and Dissociation Reagents- ZSolTM Processing Solutions, ZTMTM Transport and Rinse Media, ZAPRTM RBC Lysing Buffer, All Raw Materials, Packaging. Collection and Shipping Kits- Components meet required standards, for product safety, transport, US shipping, Sterile transport solutions, Labels & Forms (consent; Chain-of-Custody). Certificate of Analysis (COA): Example of SVF Components- Actual Cell Numbers and Viability = Dose + Bioassays = Potency, Expect at least 150,000 to 500,000 viable cells/cc, Patient variability is common Appearance of Product, Clear to turbid; Pale straw color to pinkish depending on process to remove RBCs, reagents with color (e.g., phenol red), Identity and Purity Markers, Tests Ex: MSCs High CD73, CD44, CD105, CD90; Low CD45; Low CD34; Other, Genetic or functional, Assessed with calibrated pH meter, Appropriate Sterility Testing, Endotoxin, USP testing, Mycoplasma, Tissue Donors as per 1271 regulations.

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    Use and Sale- Meets Point of Care Use Requirements, Use Pathways; e.g., Licensing, USA Only or International or Both, More than Minimal Manipulation, Living Cells or Derivative, Pre-clinical Testing, IND(s) Clinical Studies, Customers & Markets, Disease Targets, COGS vs. Pricing, Secondary Vendors, Claims & Monitoring. Ship, Store, Shelf Life- Inventory &Tracking, Validated Shippers, GMP CryoMedia, High Recovery, Stability Testing. Procurement- Autologous or Allogeneic Resection vs Other (e.g., Liposuction), Transport Reagents, Methods, Kits, Contracts/Agreements: e.g., ICD; COC; OPO. Processing- Rinsing; Dissociation Counting & Viability, Optional: Culture Cells QC Release: Potency =#+ Bioassays; Identity = biomarker[s]; Safety = endotoxin, sterility, (option) mycoplasma, Further Processing; More Testing. Components Meet GMP and CMC Needs for INDs- Processing & Manufacturing Materials: Only High Quality Materials- Active ingredient (e.g., cells), raw Materials and excipients in final product, Collection, reagents, solutions, cryostorage media, enzymes: made GMP, Bags, centrifuge containers, connectors: qualified vendors. Collection, Processing and Dissociation Reagents- ZSolTM Processing Solutions, ZTMTM Transport and Rinse Media, ZAPRTM RBC Lysing Buffer, All Raw Materials, Packaging. Collection and Shipping Kits- Components meet required standards, for product safety, transport, US shipping, Sterile transport solutions, Labels & Forms (consent; Chain-of-Custody). Certificate of Analysis (COA): Example of SVF Components- Actual Cell Numbers and Viability = Dose + Bioassays = Potency, Expect at least 150,000 to 500,000 viable cells/cc, Patient variability is common Appearance of Product, Clear to turbid; Pale straw color to pinkish depending on process to remove RBCs, reagents with color (e.g., phenol red), Identity and Purity Markers, Tests Ex: MSCs High CD73, CD44, CD105, CD90; Low CD45; Low CD34; Other, Genetic or functional, Assessed with calibrated pH meter, Appropriate Sterility Testing, Endotoxin, USP testing, Mycoplasma, Tissue Donors as per 1271 regulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    5 views1 page

    Contract Bio-Manufacturing

    Uploaded by

    davidstoffel123
    Use and Sale- Meets Point of Care Use Requirements, Use Pathways; e.g., Licensing, USA Only or International or Both, More than Minimal Manipulation, Living Cells or Derivative, Pre-clinical Testing, IND(s) Clinical Studies, Customers & Markets, Disease Targets, COGS vs. Pricing, Secondary Vendors, Claims & Monitoring. Ship, Store, Shelf Life- Inventory &Tracking, Validated Shippers, GMP CryoMedia, High Recovery, Stability Testing. Procurement- Autologous or Allogeneic Resection vs Other (e.g., Liposuction), Transport Reagents, Methods, Kits, Contracts/Agreements: e.g., ICD; COC; OPO. Processing- Rinsing; Dissociation Counting & Viability, Optional: Culture Cells QC Release: Potency =#+ Bioassays; Identity = biomarker[s]; Safety = endotoxin, sterility, (option) mycoplasma, Further Processing; More Testing. Components Meet GMP and CMC Needs for INDs- Processing & Manufacturing Materials: Only High Quality Materials- Active ingredient (e.g., cells), raw Materials and excipients in final product, Collection, reagents, solutions, cryostorage media, enzymes: made GMP, Bags, centrifuge containers, connectors: qualified vendors. Collection, Processing and Dissociation Reagents- ZSolTM Processing Solutions, ZTMTM Transport and Rinse Media, ZAPRTM RBC Lysing Buffer, All Raw Materials, Packaging. Collection and Shipping Kits- Components meet required standards, for product safety, transport, US shipping, Sterile transport solutions, Labels & Forms (consent; Chain-of-Custody). Certificate of Analysis (COA): Example of SVF Components- Actual Cell Numbers and Viability = Dose + Bioassays = Potency, Expect at least 150,000 to 500,000 viable cells/cc, Patient variability is common Appearance of Product, Clear to turbid; Pale straw color to pinkish depending on process to remove RBCs, reagents with color (e.g., phenol red), Identity and Purity Markers, Tests Ex: MSCs High CD73, CD44, CD105, CD90; Low CD45; Low CD34; Other, Genetic or functional, Assessed with calibrated pH meter, Appropriate Sterility Testing, Endotoxin, USP testing, Mycoplasma, Tissue Donors as per 1271 regulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Contract Bio-Manufacturing

    Description: Use and Sale- Meets Point of Care Use Requirements, Use Pathways; e.g.,
    Licensing, USA Only or International or Both, More than Minimal Manipulation, Living Cells or
    Derivative, Pre-clinical Testing, IND(s) Clinical Studies, Customers & Markets, Disease Targets,
    COGS vs. Pricing, Secondary Vendors, Claims & Monitoring. Ship, Store, Shelf Life- Inventory
    &Tracking, Validated Shippers, GMP CryoMedia, High Recovery, Stability Testing.
    Procurement- Autologous or Allogeneic Resection vs Other (e.g., Liposuction), Transport Reagents,
    Methods, Kits, Contracts/Agreements: e.g., ICD; COC; OPO. Processing- Rinsing; Dissociation
    Counting & Viability, Optional: Culture Cells QC Release: Potency =#+ Bioassays; Identity =
    biomarker[s]; Safety = endotoxin, sterility, (option) mycoplasma, Further Processing; More Testing.
    Components Meet GMP and CMC Needs for INDs- Processing & Manufacturing Materials: Only
    High Quality Materials- Active ingredient (e.g., cells), raw Materials and excipients in final product,
    Collection, reagents, solutions, cryostorage media, enzymes: made GMP, Bags, centrifuge
    containers, connectors: qualified vendors.

    Reference URL: http://medical.wesrch.com/paper-details/pdf-ME1XXFD1PPSSM-contract-bio


    -manufacturing

    You might also like