Introduction to biological active substances
- 1. Biological Active Substances 3.2.2015 DRA Consulting Oy www.dra.fi
- 2. Biological Active Substance • Substance that is produced by or extracted from a biological source, such as • micro-organisms, organs and tissues of either plant or animal origin, • cells or fluids of human or animal origin, • and biotechnological cell constructs • and for which a combination of physico-chemical-biological testing and the production process and its control is needed for its characterisation and the determination of its quality www.dra.fi 2
- 3. Classification 1. Traditional • Vaccines, blood components, allergenics, extracted proteins and carbohydrates etc. 2. Biotechnological • Proteins produced by recombinant DNA technology 3. Advanced therapy • Cell and gene therapy, tissue engineering www.dra.fi 3
- 4. List of biological active substances of non- recombinant origin • List of biological active substances/biological medicinal products that do not belong to one of the categories that are already considered as biological active substances/biological medicinal products by default in the current legislation is published by HMA webpages www.dra.fi 4
- 5. Differences: chemical vs. biological 5 Revers L. & Furczon E. (2010) An introduction to biologics and biosimilars. Part I: Biologics: What are they and where do they come from? Can. Pharm. J. 143: 134
- 6. 6 Chemical Biological Small Very large Simple Complex molecule or mixture of molecules Stable Unstable Manufactured by a predictable chemical synthesis Manufactured in a living system sensitive to changes in the manufacturing process Well-defined chemical structure Characterisation difficult Possible to produce identical copy Impossible to produce identical copy Immunogenicity
- 7. EU Regulation on Biologicals • Directives • Regulations • Notice to Applicants • Scientific Guidelines • GMP guidelines • European Pharmacopoeia Do not hesitate to contact us for consultation on the requirements. www.dra.fi 7
- 8. Applications for biological medicinal products • Due to complexity of biologicals • Not possible to use the Active Substance Master File (ASMF) procedure • Complete applications (2001/83/EC Articla 8(3)) • For new API • Quality, pre-clinical and clinical data • Bibliographic applications (2001/83/EC Articla 10a) • Normally not applicable for biological products • Abridged applications (2001/83/EC Articla 10 (4)) • For biosimilar products 12.2.2015 8
- 9. Variations in EU • CmDh Q&A: ”with regard to variations, specific conditions apply for biological medicinal products because of their complexity” • Classification of variations • Biologicals typically Type IB/II vs. chemical APIs and conventional products Type IA/IB • Documentation requirements • Batch data required from 3 production scale batches of biologicals vs. 2 batches for chemical APIs and conventional products
- 10. Biosimilar = A biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA • Due to the nature and manufacturing methods of biomolecules, totally identical structure cannot be achieved www.dra.fi 10
- 11. MA application – specific requirements for biosimilar products in EU • Module 1 • Module 2 • Module 3 • In addition to full Module 3, a demonstration of comparability is required • The detailed location of this data within the CTD structure can be discussed with the EMA prior to submission, but it is recommended to make use of section 3.2.R. • 3.2.A • 3.2.R • Module 4 and 5 www.dra.fi 11
- 12. • Do you need consultation on the classification? • Are you familiar with the documentation requirements? • Do you need help in writing the documentation? • Look no further, we have a team of specialists ready for you! www.dra.fi www.dra.fi 12
Editor's Notes
- Lisää uusi dia eri vaihtoehdoista valitsemalla ylänauhasta Home-alasivun kohdalla ”NEW SLIDE”