Biopharmaceutics and Relevant

J.G. Wagner, Biopharmaceutics and Relevant Pharmacokinetics. Drug Intelligence Publ., Hamilton, IL, 1971. 

W2. Wagner, J. G., Biopharmaceutics and relevant pharmacokinetics. In Drug Intelligence Publications. Hamilton, Illinois. (1971). 

J.G. Wagner, "Biopharmaceutics and Relevant Pharmacokinetics," Drug Intelligence Publications, Hamilton, 111. 1971. 

Another issue of relevance is that certain biopharmaceuticals (e.g. cytokines such as 1L-1 and TNF Chapter 9) themselves induce a natural pyrogenic response. This rules out use of the rabbit-based assay for detection of exogenous pyrogens in such products. Such difficulties have led to the increased use of an in vitro assay the Limulus ameobocyte lysate (LAL) test. This is based upon endotoxin-stimulated coagulation of amoebocyte lysate obtained from horseshoe crabs. This test is now the most widely used assay for the detection of endotoxins in biopharmaceutical and other pharmaceutical preparations. 

Finally, three relevant aspects should be mentioned to clarify the scientific, technological, and industrial position of biopharmaceuticals and animal cells. 

In the area of relevant species identification, the objectives of immuno-histochemistry and tissue-binding studies (often referred to as tissue crossreactivity studies) are to evaluate the relevance of a given species for use in toxicity studies with a biopharmaceutical and to identify expected and unexpected tissue binding of therapeutics in human and animal tissues. 

A well-characterized biological (biopharmaceutical) is a chemical entity whose identity purity, impurity, safety, potency, and quality can be determined and controlled [19,93], To be well characterized, the drug substance must be >95% of the main component and/or related isoforms [93], Well-characterized molecules are evaluating using sensitive and discriminating tests that are quantitative and relevant in vivo and in vitro potency assays [93]. The recent explosion in the availability of sophisticated, reliable, analytical instrumentation, combined with extensive, sensitive product analysis methods has resulted in great advancements in defining well-characterized biopharmaceuticals [28]. 

Identify known or predicted risks based on the nature of the target, the intended MOA of the target, and relevance of animal species to predict such risks associated with a given biopharmaceutical (discussed in Section 3.2). 

C3 Be able to draw up drug-preparation protocols and product files that meet the technical, biopharmaceutical and other relevant quality standards C4 Be able to design, set up and validate (including shelf-life tests) non-sterile, aseptic and sterile preparation processes and implement them... 

Biopharmaceutical issues to be addressed will include a discussion of the pharmaceutical development process as it relates to in vivo and in vitro performance and the general approach taken concerning bioavailability, bioequivalence, and in vitro dissolution profiles. There should be a comparative analysis of relevant studies—objectives, study design, conduct, outcome, and data analyses. The effects of formulation changes (including different strengths of product and... 

The transporter-mediated uptake of drugs into epithelial cells is emerging as a new trend in biopharmaceutics [6]. Utilization of the intestinal epithelial transporters to facilitate the absorption of drugs or prodrugs appears to be an attractive delivery approach. The purpose of this chapter is to describe the pharmaceutical and medicinal relevances of intestinal transporters. This will provide new knowledge for strategies to enhance intestinal absorption of drugs. 

In this review, we focus on the use of plant tissue culture to produce foreign proteins that have direct commercial or medical applications. The development of large-scale plant tissue culture systems for the production of biopharmaceutical proteins requires efficient, high-level expression of stable, biologically active products. To minimize the cost of protein recovery and purification, it is preferable that the expression system releases the product in a form that can be harvested from the culture medium. In addition, the relevant bioprocessing issues associated with bioreactor culture of plant cells and tissues must be addressed. 

Once filed, an NDA undergoes several layers of review (Figure 4.12). A primary review panel generally consists of a chemist, microbiologist, pharmacologist, biostatistician, medical officer and biopharmaceutics scientist. Most hold PhDs in their relevant discipline. The team is organized by a project manager or consumer safety officer (CSO). The CSO initially forwards relevant portions of the NDA to the primary review panel member with the appropriate expertise. 

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