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BIOL5181M
Manufacturing Module Reading List

Manufacturing Biopharmaceuticals, 2019/20, Semester 1
Dr Nik Kapur
n.kapur@leeds.ac.uk
Tutor information is taken from the Module Catalogue

The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines:

 Q5A (R1) Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology

1. Products Derived from Cell Lines of Human or Animal Origin http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002801.pdf

2. Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products (http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002802.pdf

3. Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002803.pdf

4. Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003280.pdf

5. Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002805.pdf

6. Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002824.pdf

7. Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002825.pdf

8. Q11 Development and manufacture of drug substances (chemical entities and biotechnological/ biological entities) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127803.pdf

9. Biopharmaceutical processing : development, design, and implementation of manufacturing processes ISBN: 9780081006238 (hbk.) : £225.00; 9780128125526 (ePub ebook) : £225.00

Front Cover Gunter Jagschies, Eva Lindskog, Karol Lacki, Parrish M. Galliher, Elsevier, 18 Jan 2018  

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10. Biopharmaceutical production technology ISBN: 9783527330294; 9783527653096 (ebk.); 3527653090 (ebk.); 9783527653126 (ePDF); 3527653120 (ePDF); 9783527653119 (ePub); 3527653112 (ePub); 9783527653102 (mobi); 3527653104 (mobi); 3527330291; 9783527653126

Front Cover Ganapathy Subramanian John Wiley & Sons, 14 May 2012  

This list was last updated on 19/09/2018