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Analytical Methods for Biotechnology Products

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Pharmacokinetics of Drugs

Part of the book series: Handbook of Experimental Pharmacology ((HEP,volume 110))

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Abstract

For the purposes of this chapter, biotechnology products will be defined as proteins (polypeptides larger than 5 kDa) and antisense oligonucleotides. Analytical methods used in disposition studies for biotechnology products range from the straightforward and familiar to the elaborate and esoteric. Experience dictates that no one method is likely to address all of the potential analytical questions that arise in these studies, e.g., quantitation of bound and free intact parent or metabolite(s), and assessment of bioactivity. These concepts also apply to peptide drugs (McMartin 1992; see also Chap. 13, this volume). The methods highlighted in this chapter are by no means inclusive, but focus on the methods for biotechnology product analysis in biological matrices supported by the largest bodies of literatur.

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Ferraiolo, B.L., Mohler, M.A. (1994). Analytical Methods for Biotechnology Products. In: Welling, P.G., Balant, L.P. (eds) Pharmacokinetics of Drugs. Handbook of Experimental Pharmacology, vol 110. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-78680-8_4

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