1.
PROTEIN DRUGS
*PHARMACOLOGY III

2.
*
*A type of drugs made of protein. These drugs
usually have large molecular weight with
protein characteristics.

3.
*Therapeutic protein drug are an important class of medicine
serving patients most in need of novel therapies. Recently
approved recombinant protein therapeutics has been
developed to treat a wide variety of clinical indications ,
including cancers,autoimmunity/inflammation,exposure to
infectious agent , and genetic disorders.
*The latest advances in protein-engineering technologies have
allowed drug developers and manufactures to fine –tune and
exploit desirable functional characteristics of proteins of
interest while maintaining (and in some cases enhancing
)product safety or efficacy or both

4.
*Protein therapeutics,which includes monoclonal antibodies as
well as large or fusion Protein,can be order –of –
magnitudelarger in size than small-molecule drugs,having
molecular weights exceeding 100kDa.
*Protein therapeutics exhibit complex secondary and tertiary
structures that must be maintained. Protein therapeutics
cannot be completely synthesized by chemical processes and
have to be manufactured in living cells or
organisms;consequently,the choices of the cell line , species
origin, and culture conditions all affect the final product
characteristics.

5.
*Protein targets, as the products are synthesized by cells or
organism ,complex purification processes are involved.further
more ,viral clearance processes such as removal of virus
particles by using filters or resin ,as well as inactivation steps
byusing low pH or detergents, are implemented to prevent
the serious safety issue of viral contamination of protein drug
substances.
*Given the complexity of therapeutic proteins with respect to
their large molecular size.

6.
*Post-translational modifications and the variety
of biological materials involved in their
manufacturing process,the ability to enhance
particular functional attributes while
maintaining product safety and efficacy
achieved through protein-engineering
strategies is highly desirable.

7.
*Protein drugs are not new to medicine.
*They have always been used in the treatment of disease even
though the quality of their production.
*The advent of recombinant technology has not only
considerably increased the scope of discovery and potential
application, but has also rendered the whole approach more
pharmacologically acceptable.

8.
*Many modern protein drugs could not emerge from the
obscurities of experimental science without the advent
genetic engineering.
*Diseases treated with proteins, include human growth
hormone to treat pituitary dwarfism, erythropoetin to treat
EPO deficiency in renal dialysis patients and t-PA to reverse
the process of early thrombsis in acute myocardial infarction.
*Whereas organic chemical drugs are used to treat diseases
such indomethacin in rheumatoid arthritis, tetracycline in
acne, steroids in atopic eczema just to mention a few.

9.
*Similarly alpha interferon is used to treat chronic hepatitis B,
chronic myeloid leukaemia and chronic granulomatous disease
(polymodal disease and therapy).
*Anexate reverses benzodiazepine induced sleep, penecillin
cures pneumococcal pneumonia, antihistamines cures
anaphylaxis, all examples of monomodal diseases and organic
chemical drugs.
*Hence no apparent inherent difference with regard to the
simplicity or complexity of the diseases treated by non-
protein and protein drugs.

10.
*The real difference arises with proteins that have species
restricted activites, whereby certain animal models or
receptor binding experiments cannot be used outside a
restricted range of animal species, as is seen with say gamma
interferon [4] but not with erythropoietin.
*Protein drugs are no more or no less in search of a disease
than their organic counterparts.
*The availability of meaningful and predictable preclinical and
clinical pharmacologic models is equally sparse for both.

11.
*Modalistic and mechanistic analyses show that protein drugs
are in fact evaluated and developed in a similar fashion to
traditional pharmaceuticals.
*Protein drugs are not new to medicine and in fact have been
around for more than a century whereas biotechnologically
produced drugs have only been around for just over a decade.
*They have a broad application in medicine and rather than be
dismayed by the advent of genetic engineering, the improved
quality and quantity of these protein drugs both as substances
as well as preparations, is a real pharmaceutical advantage.

12.
*Certain types of protein drugs could only exist because of this
technological advance.
* Of course there are new problems, but these are not proving
to be insuperable.
* Protein pharmacology however, is different in a number of
important respects and are worthy of consideration. Protein
drugs may modulate specific cellular functions,

13.
*for example: 1) growth factors not only of the
reticulo-endothelial system but probably for
every tissue in the body including nervous
tissue, 2) anti-oncogenes, 3) suppression of
Philadelphia positive clones in CML; whereas
others modulate biological.

14.
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