Good Clinical Practice
Use of transgenic animals in the manufacture of biological medicinal products for human use

Biosimilar
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

Biotech
Note for guidance on quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products

Cytokine
Production and quality control of cytokine products derived by biotechnological processes

Gene Transfer
Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products

Immunoglobulin
Note for guidance on production and quality control of animal immunoglobulins and immunosera for human use

MAb
Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products

Plant
Guideline on the quality of biological active substances produced by stable transgene expression in higher plants

Biosafety
Laboratory Biosafety Guidelines - 3rd edition 2004, Canada

EMEA Assay Validation
Note for guidance on validation of analytical procedures: text and methodology

EMEA Lentivirus
Guideline on development and manufacture of lentiviral vectors

Good Laboratory Practice
Quality practices for regulated non-clinical research and development

Good Clinical Practice
EMEA note for guidance on good clinical practice

ISSCR Guidelines for the Clinical Translation of SC
International Society for Stem Cell Research Guidelines for the clinical translation of Stem Cells

ISSCR Patient Handbook on Stem Cells Therapies
International Society for Stem Cell Research Patient handbook on Stem Cell therapies