Advances in Ligand Reagents Design and Production

IA remains the major method for bioanalysis of macromolecule drugs. The rate-limiting step of assay development is Ab production. Traditional polyclonal or monoclonal Ab production in vivo takes about three to six months. Advancement of in-vitro Ab production could reduce the time required for immunization and clone selection. The interference problems of heterophilic Ab (human anti-animal Ab) that are present in a small percentage of normal individuals could also be eliminated. 

Biotech macromolecule drugs are chemically and biologically different from the small-molecule drugs. Special considerations must be given for bioanalytical method development, validation and applications, including the purity of the re- 

The author wishes to thank the following colleagues who have contributed to the content of this chapter Rich Sukovaty, Patrick Lin, and George Scott (current and former colleagues at MDS Pharma Services) David Wells (NPS Pharmaceuticals) Surendra Bansal, Stan Kolis and David Chang (Hoffmann-La Roche). She also thanks Daniel Figeys (University of Ottawa) for critical review of the manuscript 

1 Findlay JWA, Das I Validation of immunoassays for macromolecules from biotechnology. J. Clin. Ligand Assay (1998) 

2 Toon S The relevance of pharmacokinetics in the development ofbiotechnol-ogy products. Eur.J. DrugMetab. Pharma-cokinet. (1996) 22 93-103. 

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