Biopharmaceuticals features

Over half of all biopharmaceuticals thus far approved are produced in recombinant E. coli or S. cerevisiae. Industrial-scale bacterial and yeast fermentation systems share many common features, an overview of which is provided below. Most remaining biopharmaceuticals are produced using animal cell culture, mainly by recombinant BHK or CHO cells (or hybridoma cells in... 

Over half of all biopharmacuticals thus far approved are produced in recombinant E. coli or S. cerevisiae. Industrial-scale bacterial and yeast fermentation systems share many common features, an overview of which is provided below. Most remaining biopharmaceuticals are produced using animal cell culture, mainly by recombinant BFIK or CFiO cells (or hybridoma cells in the case of some monoclonal antibodies Appendix 1). While industrial-scale animal cell culture shares many common principles with microbial fermentation systems, it also differs in several respects, as subsequently described. Microbial fermentation/animal cell culture is a vast speciality area in its own right. As such, only a summary overview can be provided below and the interested reader is referred to the Further Reading section. 

Even on their own these are profound issues in the development of any product, but they have very particular implications for the difficult processes of formal pharmaceutical development, clinical trial, and marketing authorization of the full range of biopharmaceuticals. The answers will define major features of how the experimental work is done and the resources required to do it. 

A tabular listing (ETA) of all biopharmaceutical studies conducted is recommended. Brief narrative descriptions (e.g., similar to an abstract for a journal article) are to share relevant features and outcomes of each study that provided important in vitro or in vivo data and information relevant to the BA and/or BE of a drug candidate. These narratives can be abstracted from clinical study reports (i.e., the synopsis of reports prepared according to ICE guideline E3) and should include reference to the full report. A comparison of results across studies, using both text and tables, is to pay particular attention to differences in in vitro dissolution, BA, and comparative BA results. This comparison is to consider... 

Pharmaceutical companies are increasingly interested in developing products based on proteins, enzymes, and peptides. With the development of such products comes the need for methods to evaluate the purity and structural nature of these biopharmaceuticals. Proteins, unlike traditional pharmaceutical entities, rely on a specific secondary structure for efficacy. Methods to monitor the secondary structure of pharmaceutically active proteins, thus, is necessary. Infrared spectroscopy provides a way to study these compounds quickly and easily. Byler et al. (65) used second-derivative IR to assess the purity and structural integrity of porcine pancreatic elastase. Seven different lyophilized samples of porcine pancreatic elastase were dissolved in D20, placed in demountable cells with CaF2 windows, and IR spectra obtained. The second derivatives of the spectra were calculated and the spectral features due to residual water vapor and D20 removed. 

This novel, pain-free, oral insuHn formulation has a series of positive attributes rapid absorption, simple (user-friendly) administration technique, precise dosing control (comparable to injection within one unit) and bolus delivery. Altogether these patient compliance features make it a unique modern biopharmaceutical. 

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