Recombinant human proteins

Bernard GR, Vincent JL, Laterre PF, et al. Recombinant Human Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001 344 699-709. 

Antihemophilic factor) Corporation [BHK cells-expressed recombinant human protein]... 

Working, P., and P. Cossum. 1991. Clinical and preclinical studies with recombinant human proteins effect of antibody production. In P. Garzone,W. Colburn, and M. Mokotoff(Eds.), Peptides,peptoids, and proteins. Harvey Whitney Books, Cincinnati, OH, pp. 158—168. 

Schellekens H, Casadevall N Immuno-genicity of recombinant human proteins causes and consequences. / Neurol. 

Recombinant human proteins may also be expressed in baculovirus, such as Spodoptera frugiperdu (SF9) cells. These viruses possess large genomes capable of accommodating extremely large exogenous DNA sequences. 

While useful for evaluating substrate reduction and tissue distribution, the knockout mouse also presented specific challenges to the preclinical development program. After repeated administration of rhGAA, a predictable hypersensitivity response to the recombinant human protein was observed. Frequently this reaction resulted in morbidity and mortality associated with test article administration. This hypersensitivity reaction responded to diphenhydramine prior to, and as necessary, during dosing however, such intervention complicated interpretation of toxicity studies. 

Porter S. Human immune response to recombinant human proteins. / Pharm Sci 2001 90 1-11. 

Grinnell, B.W., Berg, D.T., Walls, J., and Yan, S.B. (1987). Trans-activated expression of fully gamma-carboxylated recombinant human protein C, an anti thrombotic factor. Bio/Technology 5,1189 1192. 

Marafino, Jr., B.J., Young, J.D., Greenfield, I.L., and Kopphn, J.R. (1988). The appropriate lexicological testing of recombinant human proteins. In Therapeutic Peptides and Proteins Assessing the New Technologies. D.R.Marshak and D.T. Liu, eds. (New York Cold Spring Harbor Laboratory), pp. 175 187. 

DNA technology. Reteplase (tV 15 min) is another recombinant human protein. 

Poor or irreproducible delivery. These are problems such as inadequate absorption from the gastrointestinal tract (e.g., the absence of oral absorption of cromolyn sodium or recombinant human proteins) and presystemic and systemic metabolism of the active compound before it reaches the site of action... 

Despite these disadvantages, the major benefit of transgenic technology offers a means to produce proteins at a very low cost. Mammalian cell culture systems are often used for expression of recombinant human proteins (rHP), as the latter can only be obtained in a biologically active conformation when produced in such cells. However, this approach has limited production capacity and is expensive. In contrast, the production of rHP in milk of transgenic cattle is a safe and less-expensive alternative with the advantage of better protein output (Brink et al., 2000). 

Eprex (Epoetin alpha)[CHO-expressed recombinant human protein] JANSSEN CILAG Liquid 1 mL multidose vial 0.3, 0.4, 0.5, 0.6, 0.8, and 1.0 mL single dose syringe(s)... 

Araujo, S.J., Tirode, F., Coin, F., Pospiech, H., Syvaoja, J.E., Stucki, M., Hubscher, U., Egly, J.M., and Wood, R.D. (2000) Nucleotide excision repair of DNA with recombinant human proteins definition of the minimal set of factors, active forms of TFIIH, and modulation by CAK. Genes Dev., 14, 349-359. 

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