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Manufacturing Module Reading List

Manufacturing Biopharmaceuticals, 2021/22, Semester 1
Dr Darren Tomlinson
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

2. Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products (

3. Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

4. Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products

5. Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products

6. Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products

7. Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients

8. Q11 Development and manufacture of drug substances (chemical entities and biotechnological/ biological entities)

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