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Biotechnological/biological products quality

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

International Conference of Harmonization Guidelines, Q5B Quality of Biotechnological Products Analysis of the Expression Construct in Cells used for Production of R-DNA Derived Protein Products (1995), Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products (1997). [Pg.346]

ICH (1998a), CPMP. Quality of biotechnological products derivation and characterization of cell substrates used for production of biotechnological/biological products, Geneva. Available at http //www.ich.org/LOB/media/MEDIA429.pdf (accessed October 2006). [Pg.370]

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]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q5C Quality of biotechnological products Stability testing of biotechnological/biological products, Nov. 30,1995. [Pg.29]

Guideline Q6A—Specifications for New Drug Substances and Products Chemical Substances Guideline Q6B—Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Other Quality Guidelines Relevant to Setting Specifications... [Pg.387]

Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003) Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003) Q5C Quality of Biotechnological Products Stability Testing of Biotechnological/ Biological Products ... [Pg.294]

ICH. Guidance for Industry, Q5C. Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products. ICH-Q5C, 1996, 10 July. [Pg.389]

Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products (General Chapter 1049), 2004, in United States Pharmacopeia, 27th rev., and National Formulary, 22nd ed., The United States Pharmacopeial Convention, Inc., Rockville, MD, pp. 481 184. [Pg.188]

ICH, Q5C Guideline for industry quality ofbiotechnological products stability testing of biotechnological/biological products, July 1996. [Pg.116]

Q5D Quality of biotechnological products derivation and characterization of cell substrates used for production of biotechnological/biological products... [Pg.210]

GL40 Quality specifications Test Procedures and Acceptance Criteria for new Biotechnological/Biological Veterinary Medicinal Products... [Pg.133]

See other pages where Biotechnological/biological products quality is mentioned: [Pg.16]    [Pg.370]    [Pg.3]    [Pg.308]    [Pg.17]    [Pg.373]    [Pg.374]    [Pg.382]    [Pg.384]    [Pg.335]    [Pg.185]    [Pg.1664]    [Pg.395]    [Pg.360]    [Pg.367]    [Pg.252]    [Pg.251]    [Pg.3]    [Pg.228]    [Pg.60]    [Pg.312]    [Pg.17]    [Pg.96]    [Pg.547]    [Pg.331]    [Pg.3]   
See also in sourсe #XX -- [ Pg.9 ]



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