Biologicals: active substance
HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on biological drug substances help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Manufacture, characterisation and control of the active substance
Guidelines
- Chemistry of active substances (chemistry of new active substances)
- ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products
- ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnologial/biological products
- ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities)
- ICH Considerations: oncolytic viruses
- Allergen products: production and quality issues
- Development and manufacture of lentiviral vectors
- Development, production, characterisation and specifications for monoclonal antibodies and related products
- Gene therapy product quality aspects in the production of vectors and genetically modified somatic cells
- Human cell-based medicinal products
- Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer
- Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
- Production and quality control of animal immunoglobins and immunosera for human use
- Production and quality control of medicinal products derived by recombinant DNA technology
- Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
- Quality of biological active substances produced by stable transgene expression in higher plants
- Quality of biological active substances produced by transgene expression in animals
- Quality, preclinical and clinical aspects of gene therapy medicinal products
- Use of starting materials and intermediates collected from different sources in the manufacturing of biological products
- Xenogeneic cell-based medicinal products
Reflection papers
- Design modifications of gene therapy medicinal products during development
- In-vitro cultured chondrocyte containing products for cartilage repair of the knee
- Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors
- Stem cell-based medicinal products
Public statements
- DNA and host cell protein impurities, routine testing versus validation studies
- Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products
Questions and answers
Concept papers
Comparability and biosimilarity
Guidelines
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products products
- Similar biological medicinal products
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
Reflection papers
Plasma-derived medicinal products
Guidelines
- Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk
- Plasma-derived medicinal products
- Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products
Reflection papers
Position statements
Plasma master file
Guidelines
- Requirements for plasma master file certification
- Scientific data requirements for plasma master file
- Epidemiological data on blood transmissible infections
- Validation of immunoassay for the detection of antibody to human immunodeficiency virus in plasma pools
- Validation of immunoassay for the detection of hepatitis B virus surface antigen in plasma pools
Position statements
- Quality and safety assessment for the plasma master file (PMF) certification with regard to donor deferral criteria for sexual risk behaviour - Scientific guideline
- Non-remunerated and remunerated donors: safety and supply of plasma-derived medicinal products
Questions and answers
Vaccines
Guidelines
- Adjuvants in vaccines for human use
- Development of vaccinia virus-based vaccines against smallpox
- Influenza vaccines - quality module
- Quality aspects of mRNA vaccines
- Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines
- Requirements for vaccine antigen master file certification
- Scientific data requirements for a vaccine antigen master file
Points to consider
Public and position statements
- Evaluation of bovine spongiform encephalopathy risk via the use of materials of bovine origin in or during the manufacture of vaccines
- Quality of water used in the production of vaccines for parenteral use
- Testing for simian virus 40 (SV40) in polio virus vaccines
- Viral safety of oral poliovirus vaccine (OPV)
Concept papers
Questions and answers