Characteristics of biotechnology drugs
Characteristics of biotechnology drugs:
1. Large molecular weight and complex structure
The production mode of drugs derived from biotechnology is the product of protein or polypeptide produced by living organisms modified by genes, or complementary oligonucleotides synthesized based on target gene chemistry. The products obtained are often of large molecular weight and complex molecular structure.
2. Species specificity
There are species specificity in biotechnology drugs. The pharmacological activities of many biotechnological drugs are related to animal species and tissue specificity, mainly due to the differences of animal species in the drug itself and the gene sequences of drug action receptors and metabolic enzymes. Some of the proteins and polypeptides derived from human genes have very different homologies from the corresponding proteins or polypeptides of animals, so they are insensitive to some animals, or even have no pharmacological activity.
3. High safety
Biotechnology drugs are naturally existing proteins or polypeptides of human beings. They are small in amount and strong in activity. A small amount of them will produce significant effects. Relatively speaking, they have less side effects, lower toxicity and higher safety.
4. Active protein or peptide drugs are relatively unstable
Biotech active protein or peptide drugs are unstable, volatile, easy to inactivate, and easy to be contaminated by microorganisms and destroyed by enzymatic hydrolysis.
5. Gene stability of source drug is very important
The genetic stability of biotechnology derived drugs, the stability of production strains and cell lines and the stability of production conditions are very important. Their variation will lead to changes in biological activity or unexpected or unexpected biological activity.
6. Immune
Immunogenicity of biotechnology drugs. Many biotechnological drugs from humans have immunogenicity in animals, so repeated administration of such drugs in animals will produce antibodies. Some human derived proteins can also produce serum antibodies in humans, which may be caused by the difference between the recombinant drug proteins and human natural proteins in structure and configuration.
7. The half-life of drugs from many sources is short in vivo
Biotech derived drugs, many of which have short half-life in vivo, degrade rapidly and extensively in vivo.
8. Receptor effect
Many biotechnological drugs play their pharmacological effects by binding to specific receptors and signal transduction mechanism, and the distribution of receptors has animal species specificity and tissue specificity, so the distribution of drugs in vivo has the characteristics of tissue specificity and quick response to drug effects.
9. Multiplicity and network effect
Many biotechnology drugs can act on a variety of tissues or cells, and induce and regulate each other in the human body, cooperate or antagonize each other, forming a network effect, so they can have multiple functions and play a variety of pharmacological effects.
The complexity of the production system of biotechnology derived drugs leads to their homology, and the changes in consistency and safety between batches are greater than those of chemical products. Therefore, the requirements of production process inspection, GMP steps and quality control are more important and strict.