Recombinant DNA products

BollonA.P. (l9S4)Recombinant DNA Products Insulin, Interferon andGrowth Hormone. Boca Raton, Florida CRC Press. 

Biotechnology era beginning First recombinant DNA products Human insulin Human growth hormone Interferons, etc. Monoclonal antibodies Nucleotide blockage Growth in use of natural products and neutraceuticals... 

Stebbing, N. and Week, P.K. (1984). Preclinical assessment of biological properties of recombinant DNA-derived human interferons. In Recombinant DNA Products Insulin, Interferon and Growth Hormone, (Bollon, A.P., Ed.). CRC Press, Boca Raton, FL. 

In the late 1970s, development of recombinant DNA products utilizing knowledge of cellular and molecular biology commenced. The biotechnology industry became a reality. 

In some ways, the use of animals (almost always mammals) as substitutes for bacteria in the recombinant DNA production of drugs is a natural and obvious extension of the techniques originally developed for the manufacture of insulin, human growth hormone, and other pharmaceuticals. Live animals have a built-in production... 

Interferon alfa-2b (Intron A) is a recombinant DNA product derived from the interferon alfa-2b gene of human white blood cells. Its mechanism of antitumor action involves binding to a plasma membrane receptor but is otherwise poorly understood. Its serum half-life is 2 to 3 hours after parenteral administration. 

In 1996, about 10 years after the introduction of the first recombinant DNA product for human use, the FDA modified and streamlined the approval process for biotechnology products considered to be well characterized. These modifications, in essence, established the direction of how biologic macromolecules are researched and developed today in biotechnology-based and traditional pharmaceutical companies [2]. Well-characterized biotechnology products include (1) synthetic peptides consisting of fewer than 20 amino acids, (2) monoclonal antibodies and derivatives, and (3) recombinant DNA-derived products. Anticipating future developments, the FDA is also prepared to consider DNA plasmid products as well-characterized when the first medicinal in this class is submitted for approval. CBER now approves well-characterized biopharmaceuticals under the BLA process [3]. 

PaUvizumab, humanized monoclonal IgGi against F protein of respiratory syncytial virus (RSV), recombinant DNA product... 

Commercial insulin preparations differ in a number of ways, such as differences in the recombinant DNA production techniques, amino acid sequence, concentration, solubility, and the time of onset and duration of their biologic action. 

Improvement and Experimental Validation of Protein Impurity Immunoassays for Recombinant DNA Products... 

Brandis JW, Ditullio DF, Lee JF, Armiger WB (1989) Process controlled temperature induction during batch fermentations for recombinant DNA products. In Computer applications in fermentation technology. Elsevier, London, p 235... 

Anicetti, V. R. (1990). Improvement and experimental validation of protein impurity immunoassays for recombinant DNA products. ACS Sytnp. Ser. 434, 127-140. 

For recombinant DNA products, including rDNA-derived monoclonal antibodies produced from cellular sources, the guideline states that the submission should include a detailed description of the host cell and expression vector systems and their preparation, including the following ... 

Hurnulin [Lilly]. TMforsyntheticinsulin.lt is the first recombinant DNA product to be made commercially approved by EDA. 

The contributions in this book illustrate the important role of downstream processing and purification processes in the application of biotechnology. We expect that this trend will continue, especially with the proliferation of recombinant proteins derived from the recombinant DNA technology. All of the techniques presented in this book can play a critical role in the downstream processing and in the effective production of biological products. Most of the early fears related to the safety aspects of recombinant DNA products have been assuaged since studies showed that quantities of DNA (obtained from Chinese hamster ovary cells) at the hundred of pg level did not result in the formation of tumors in newborn rats (155). 

Growth hormone deficiency may be hereditary or a consequence of a pituitary tumor or head trauma. Congenital GH deficiency results in shortened stature (dwarfism). Currently, affected children are treated with commercially produced GH, a recombinant DNA product. In Laron s dwarfism, exogenous GH has no effect on the patient s cells because of a defective GH response mechanism. 

The introduction of biotechnology-derived drugs has increased rapidly since the first FDA approval in 1982 of Lilly s recombinant DNA product, Humlin. 

Product Biologicals Biopharmacenticals Biotechnology products Recombinant DNA products API Bnlk Drng snbstance Protein... 

The gene for a eukaryotic polypeptide hormone was isolated, cloned, sequenced, and overexpressed in a bacterium. After the polypeptide was purified from the bacterium, it failed to function when it was subjected to a bioassay in the organism from which the gene was isolated. Speculate why the recombinant DNA product was inactive. 

Describe the Holliday model for homologous recombination. Explain how resolution of the Holliday Junction intermediate can form different recombinant DNA products. 

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