In this article we will discuss about Biopharmaceuticals:- 1. Subject Matter of Biopharmaceuticals 2. Classification of Biopharmaceuticals 3. Benefits.
Subject Matter of Biopharmaceuticals:
In this modernized world, pharmaceutical products have become the backbone of medicinal therapies. Bio pharmaceutics is the field of study concerning biopharmaceuticals that are nothing but medical drugs manufactured using biotechnology.
The term ‘biopharmaceutical’ was first introduced in the 1980s which precisely described a class of therapeutic proteins produced by modern biotechnological techniques. The large majority of biopharmaceutical products are pharmaceuticals that are derived from various life forms. Today approximately one in every four new drug thus introduced in the market is a biopharmaceutical.
The majority of biopharmaceuticals thus approved or in development stage are proteins based produced via genetic engineering which also encompass nucleic-acid-based, i.e., deoxyribonucleic acid (DNA) or ribonucleic acid(RNA)-based products, and whole-cell-based products.
Another potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. They can be used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.
The products include a range of hormones, blood factors and thrombolytic agents, as well as vaccines monoclonal antibodies and protein based therapeutic agents. Most of the biopharmaceuticals approved till date are intended for human usage only.
The first such substance approved for therapeutic use was recombinant human insulin. However, a number of products for veterinary application have also come on the market. One early such example is that of recombinant bovine GH (Somatotrophin), which was approved in the U.S.A. in the early 1990s and used to increase milk yields from dairy cattle.
At least more than 1000 potential biopharmaceuticals are currently being evaluated in clinical trials. The majority of these are still in early stage trials. Vaccines and monoclonal antibody-based products represent the two biggest product categories.
Regulatory factors (e.g., hormones and cytokines) and gene therapy and antisense-based products also represent significant groupings. A small number of whole-cell-based therapeutic products have also been approved to date.
All contain mature, fully differentiated cells extracted from a native biological source. Improved techniques now allow the harvest of embryonic and, indeed, adult stem cells, bringing the development of stem-cell-based drugs one step closer. Hence, the products of pharmaceutical biotechnology play an important role in the health care industry and are likely to assume an even greater relative importance in the future.
Classification of Biopharmaceuticals:
a. Blood factors (Factor VIII and Factor IX)
b. Thrombolytic agents (tissue plasminogen activator)
c. Hormones (insulin, glucagon, growth hormone, gonadotropins)
d. Haematopoietic growth factors (Erythropoietin, colony stimulating factors)
e. Interferon’s (Interferon’s-α, β, γ)
f. Interleukin-based products (Interleukin-2)
g. Vaccines (Hepatitis B surface antigen)
h. Monoclonal antibodies (Various)
i. Additional products (tumour necrosis factor, therapeutic enzymes).
Benefits of Biopharmaceutical Products:
1. Highly effective
2. Highly specific
3. Fewer side effects
4. Non-carcinogenic
5. Safe
6. Easy commercial production.