Biotechnological/biological products

Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products... [Pg.60]

Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Specifications... [Pg.60]

Quality of biotechnology products, analysis of the expression construct in cells used for production of r-DNA derived protein product Quality of biotechnological products stability testing of biotechnological/Biology products Availability of Draft Guideline on Quality of... [Pg.76]

Biotechnological/Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Notice Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice... [Pg.76]

FDA (1999). ICH harmonised tripartite guideline. Specifications Test procedures and acceptance criteria for biotechnological/biological products. Fed Regist 64 44928. [Pg.302]

International Conference on Harmonization. Derivation and characterization of cell substrates used for production of biotechnological/biological products, in Harmonized Tripartite Guideline, ICH, 2001. [Pg.318]

Source International Conference on Harmonization. Derivation and Characterisation of Cell Substrates Used for Production of Biotechnology/Biological Products, Q5D, July 1997. http //www.ich.org/LOB/media/MEDIA429.pdf [accessed September 28,2007]. [Pg.343]

International Conference on Harmonization. Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, ICH, 1999. [Pg.357]

International Conference on Harmonization (1999), Harmonised Tripartite Guideline Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, ICH-Q6B, available http //www.fda.gov/cder/guidance/index.htm. [Pg.787]

Q5C Stability testing of biotechnological/biological products (annex to Q1A)... [Pg.865]

Q6B Test procedures and acceptance criteria for biotechnological/biological products... [Pg.865]

The ICH expectations are that acceptance criteria or limits of acceptability will be established prior to final product characterization, regardless of the host cell system. More important, with respect to system, the final product should be compared to appropriate reference standards (if available), and ideally, with the naturally occurring protein. Products should be thoroughly characterized with respect to five distinct criteria (ICH Guideline, Specification Test Procedures and Acceptance Criteria for Biotechnological/Biological Products [15]) ... [Pg.30]

In the early days of biotechnology product development, the focus was on quality issues [4] or process-related impurities.The concerns at that time were for carryover of other cellular proteins and DNA and for contamination with endotoxins, chemicals, and viruses. Of course, these concerns still exist, but methods for purification and assays for evaluation of clearance have alleviated the need for the safety assessment scientist to focus on contaminants instead they are now asked to focus on the pharmacological activity of the molecules. An ICH guidance (Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) addresses the specific issues related to the manufacturing process [6], Other product-related issues such as impurities do need to be considered by the safety assessment scientist, for... [Pg.113]

ICH Q5E. Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 18 November 2004. [Pg.159]

ICH/U.S.FDA Comparability of biotechnology-derived, ICH Q5E Comparability of biotechnological/biological products for changes made in the manufacturing process 10... [Pg.167]

Q6A of Cell Substrates used for Production of Biotechnological/ Biological Products Specifications Test procedures and Acceptance Criteria for New Drug CPMP/ICH/367/95 Step 5... [Pg.761]

International Conference on Harmonization (1996). Final Guidelines on Stability Testing of Biotechnological/Biological Products. Federal Register 61, 36465-36469. [Pg.65]

Guidelines on stability testing of biotechnological/biological products. [Pg.272]

Guidelines on stability testing for biotechnological/biological products (Notification No. 6 of the PAB, 1998). [Pg.290]

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