ISSCR Patient Handbook on Stem Cells Therapies
ISSCR Patient Handbook on Stem Cells Therapies International Society for Stem Cell Research Patient handbook on Stem Cell therapies
General guidelines
Clinic
ISSCR Patient Handbook on Stem Cells Therapies
ISSCR Patient Handbook on Stem Cells Therapies International Society for Stem Cell Research Patient handbook on Stem Cell therapies
PDFISSCR Guidelines for the Clinical Translation of SC
International Society for Stem Cell Research Guidelines for the clinical translation of Stem Cells
PDFDrugs
Plant
Guideline on the quality of biological active substances produced by stable transgene expression in higher plants
MAb
Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products
Immunoglobulin
Note for guidance on production and quality control of animal immunoglobulins and immunosera for human use
Cytokine
Production and quality control of cytokine products derived by biotechnological processes
Biotech
Note for guidance on quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products
Biosimilar
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
Animals
Use of transgenic animals in the manufacture of biological medicinal products for human use
Drugs
Plant
Guideline on the quality of biological active substances produced by stable transgene expression in higher plants
PDFMAb
Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products
PDFImmunoglobulin
Note for guidance on production and quality control of animal immunoglobulins and immunosera for human use
PDFCytokine
Production and quality control of cytokine products derived by biotechnological processes
PDFBiotech
Note for guidance on quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products
PDFBiosimilar
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
PDFAnimals
Use of transgenic animals in the manufacture of biological medicinal products for human use
PDFLaboratory
Good Laboratory Practice
Quality practices for regulated non-clinical research and development
EMEA Lentivirus
Guideline on development and manufacture of lentiviral vectors
EMEA Assay Validation
Note for guidance on validation of analytical procedures: text and methodology
Biosafety
Laboratory Biosafety Guidelines – 3rd edition 2004, Canada
Laboratory
EMEA Assay Validation
Note for guidance on validation of analytical procedures: text and methodology
PDF