Regulatory Aspects of Impurities in Biological Products - IIR

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Q6B Defines Process-Related Impurities Impurities derived from the process Host cell proteins or source derived proteins Host cell nucleic acids Cell culture components Antibiotics, chemical induction reagents (methyltrexate) Medium components like transferrin or insulin Down-stream process related impurities Organic solvents and detergents (TNBP, tween, triton) Column leachables (protein A, antibodies, small ligands, metals) Enzymes (proteases) Denaturants (guanidine HCl)
Q6B Defines Product-Related Impurities Variants of the product that arise during manufacturing and/or storage that do not have propertie comparable to those of the desired product. Product precursors Product degradants Fragments Dimers, trimers, oligomers Oxidation, deamidation, deglycosylation, etc.
Page 1 and 2: Regulatory Aspects of Impurities in
Page 3 and 4: Where It Is Written FDA has no spec
Page 5 and 6: ICH Q6B Overview Specifications; Te
Page 7: Q6B Defines Product-Related Substan
Page 11 and 12: Q6B Suggests a Specifications Desig
Page 13 and 14: Process-Related Impurity Decision T
Page 15 and 16: Question 2 Can you measure the amou
Page 17 and 18: Is the impurity qualified by toxico
Page 19 and 20: Question 6 Is the level of the impu
Page 21 and 22: Process Consistency Major component

Regulatory Aspects of Impurities in Biological Products - IIR

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