DynaPharmaTM
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
PyrogenTM 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.
DynaPharmaTM
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.
DynaPharmaTM
Pyrogen
