DynaPharma™ Product Line

The enforcement role of the Food and Drug Administration has been strengthened during the years of the Obama administration in an attempt to assure the public of a safer food and drug supply. Tougher regulatory controls have placed heightened demands upon the pharmaceutical and nutraceutical industries to carefully quality control raw materials, manufacturing processes and finished goods. High quality DAI alumina and silica are currently incorporated into current Good Manufacturing Practices (cGMPs) for the production of ethical pharmaceutical compounds originating as natural plant alkaloids and being used in the treatment of malignancies.

DynaPharma Pyrogen™ was developed specifically to address the needs of the ethical pharmaceutical and nutraceutical industries. For those drugs which are manufactured using bacterium as “cellular factories” a significant problem has been the removal of endotoxins. These are lipopolysaccharides located on the outer lay of the cell membranes of gram negative bacteria and they make up the majority of the pyrogens which must be removed from pharmaceutical products, biologicals for injection and media used for cell culture. Small amounts of endotoxin when injected into patients may cause systemic inflammatory reactions running the spectrum from tissue injury to endotoxin shock to death. Gram negative bacteria are able to release small amounts of other materials capable of causing endotoxin reactions such as exotoxins, peptidoglycans and muramyl peptides. Specially designed alumina with surface modified chemical moieties has proven to provide a superior tool for the purification of endotoxins due to its amphoteric property.

The term decolorization as used in the pharmaceutical industry is a misnomer. It does not mean to literally remove color. That would be too simple, too literal. Rather, to decolorize means to remove impurities of one sort or another. In the decolorization of a fermented product process stream one often uses ion exchange resins. However, a superior solution lies in the use of specially designed DAI activated alumina.

DynaPharma™ Decolorizer was developed as a replacement for ion exchange resins in the fermentation process of antibiotic manufacturing. This is especially important for the processing of glycopeptides drugs such as vancomycin which are produced through the fermentation of Actinomycetes species. However this specialty alumina can be fully modified in terms of pore and particle size to adsorb any high molecular weight organic material.

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