BIOPHARMACEUTICALS

BY Miss GONSHA REHEMA

Definition of biologicalS
 The broadest meaning is- something produced from a living source eg
hormones, vitamins(ABC), enzymes, extracts, crude drugs.
 The narrowest meaning is-Immunising agents such as Vaccines, toxoids,
Immune globulins, Antitoxins, Antivirals serum, Hyperimmune serum,
Antivenom, Diagnostics antigens, Diagnosis antibodies.

Uk defination
 These are substances whose purity or potency can not be adequately tested
by chemical means.
WHO Defination
Biological substances of biological origin (or semi-
synthetic analogues) whose potency and safety cannot be
evaluate by chemicals or physicals tests alone.eg serum,
toxins, toxoids, antitoxins, vaccines,blood, blood
components, hormones, xerographs, genes, and
other components.
BIOLOGICAL ASSAYS
These are methods used to estimate the potency of
preparations by means of its effects on some type of living
matter, when the potency can not be adequately
determined by physical or chemical methods alone.

Biological testing= biological assay and qualitatives

tests.
Biological standardisation
Tests or procedures carried out to ensure or find out that a
product or substance is at least up to the agreed efficacy,
safety and quality in many cases using biological testing.
Biological standardisation is reserved for
use if
Chemical identity of the active principle has not been
fully elucidated
No adequate chemical assay has been devised for the
active principle although its chemical structure has
been well established e.g. insulin
The drug is composed of a complex mixture of
substance and activity e.g. posterior pituitary extract,
digitalis glycosides.
The purification of the crude drug sufficient for
performance of chemical assay is not possible or
practical e.g. groundnut and many other oils.

The chemical assay is not a valid indication of

biological activity due for instance to lack of
differentiation between active isomers, for example L-
form of tubocurarine is the active one.
Biologicals Conventional drugs

Large molecules not well defined eg > Synthetic organic compounds with
1000 mwt. defined.

Composed of or extracted from living Produced through chemical synthesis

organisms

Heat and shear sensitive Very stable, not heat sensitive

Are protein or carbohydrate based Micro molecules Mwt <500kd(Kilo

products > 1000 Mwt daltons)

Active and Utility generally not known Both are kown

Can not be adquately assyed by Can be assayed by quatitive chemicals

chemical or physical means alone so and physical analysis.
resort to biological methords
Biological assay Chemical assay

Measures the actual biological activity Qualitative determination of amount

of a given sample. and a specific compound structure
moiety present in a given sample

Quantitative accuracy is lower Higher

More time consuming Less time consuming

More expensive Less expensive

Technical interpretations involved Less subjective

which may be subjective

Variations in the physical state exerts Not reflected in the results of the
augmentry or inhibitory influence chemical assay.
Or the result