Biopharmaceuticals and synthetic drugs
Biopharmaceutical Classification System
"BCS" To provide a scientific approach to the classification of drug
compounds based on dose-related solubility and intestinal permeability in
combination with the dissolution properties of oral immediate release (IR)
dosage forms. The purity of the active ingredient in a pharmaceutical product and the composition of the final
product can be verified relatively easily. High-purity chemicals from a variety
of sources, including those formed from mixtures
of isomers, can
often be considered similar or even identical for practical purposes. The
situation is different for
biopharmaceuticals
to conduct drug discovery. Due to biological differences between
expression systems and the applied process conditions, some degree of variation
can occur, even between different batches of the same product. Therefore,
lot-to-lot variation should be monitored to ensure compliance. within a
specific range, these aspects of Drug Discovery have implied. The properties of the
active pharmaceutical ingredients in biopharmaceuticals, in addition to their primary structure
(e.g., amino acid sequence), depend significantly on the manufacturing method.
For this reason, it has been suggested that the "product identification
procedure" for biopharmaceuticals 6, 7. Several protein
expression systems have been established over the years, each with advantages
and disadvantages.
- Organs and tissues
- Gene Therapy
- Peptides components
- Proteins in antibiotics