By Gail K. Sofer and L. E.E. Nystrom (Auth.)
Learn and improvement into organic items for healing use has elevated dramatically during the last 10 years. With this, strict regulatory specifications were imposed via gurus akin to the U.S. nutrients & Drug management, in order that this day validation has turn into a key factor within the biopharmaceutical industry.
This concise ebook addresses validation concerns within the chromatography of biotherapeutics. It covers strategy layout, qualification and validation, together with an outline of analytical suggestions frequent within the validation of procedures. A concluding part reviews on product changeover and offers 4 case reviews
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Extra info for Process Chromatography. A Guide to Validation
E. ion exchangers, to determine the type and quantity of functional groups. g. affinity and hydrophobic interaction. g. the solvent used for packaging. Microorganism contamination is usually determined by the manufacturer. If an immobilized monoclonal antibody is employed in the purification, the monoclonal antibody must be of a similar quality to the monoclonal antibodies used 6 for parenteral injection. Function tests are generally performed by the media manufacturer with standard proteins under narrowly defined conditions.
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And Lechtman, M. D. Microbiology, 3rd edn. , London, 1980. Korczynski, M. S. International Standards Organization Technical Committee 198: Worldwide standards for sterilization. PDA Lett. XXVI (1990) 4. PDA Bioburden Recovery Validation Task Force. Technical report: bio- PROCESS DESIGN 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 29 burden recovery validation. J. Parenteral Sei. Technol. 44 (1990) 324-331. Berglof, J . , Adner, Ν. P. and Doversten, S. Y. Inactivation of microbial contamination in chromatographic separation media using sodium hydroxide.
Process Chromatography. A Guide to Validation by Gail K. Sofer and L. E.E. Nystrom (Auth.)