Introduction and Definitions Biotechnology is the use of living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”. Depending on the tools and applications, it often overlaps with the (related) fields of bioengineering, biomedical engineering, biomanufacturing, molecular engineering, etc. For thousands of years, humankind has used biotechnology in agriculture, food production, and medicine.The term is largely believed to have been coined in 1919 by Hungarian engineer Károly Ereky. In the late 20th and early 21st centuries, biotechnology has expanded to include new and diverse sciences such as genomics, recombinant gene techniques, applied immunology, and development of pharmaceutical therapies and diagnostic tests.

Genomics is an area within genetics that concerns the sequencing and analysis of an organism’s genome. The genome is the entire DNA content that is present within one cell of an organism. Experts in genomics strive to determine complete DNA sequences and perform genetic mapping to help understand disease. Genomics also involves the study of intragenomic processes . Genomics does not involve single gene research unless the purpose is to understand a single gene’s effects in context of the entire genome.

The terms “proteome” and “proteomics” mirror the terms “genomics” and “genome”. Since the first use of the term “proteome”, its meaning and scope have narrowed. Post-translational modifications, alternative splice products, and proteins intractable to classic separation techniques have presented a challenge towards the realization of the conventional definition of the word. Proteomics include protein-protein interaction studies, protein function, protein modifications, and protein localization studies. The fundamental goal of proteomics is not only to pinpoint all the proteins in a cell, but also to generate a complete three-dimensional map of the cell indicating their exact location. Proteomics runs parallel to genomics. The starting point for genomics is a gene in order to make inferences about its products (i.e. proteins), whereas proteomics begins with the functionally modified protein and works back to the gene responsible for its production.

Pharmaceutical biotechnology is a relatively new and growing field in which the principles of biotechnology are applied to the development of drugs. A majority of therapeutic drugs in the current market are bioformulations, such as antibodies, nucleic acid products and vaccines. Such bioformulations are developed through several stages that include: understanding the principles underlying health and disease; the fundamental molecular mechanisms governing the function of related biomolecules; synthesis and purification of the molecules; determining the product shelf life, stability, toxicity and immunogenicity; drug delivery systems; patenting; and clinical trials

What are biopharmaceuticals? A biopharmaceutical is a protein or nucleic acid based biopharmaceutical product used for therapeutic or in vivo diagnostic purposes, which is produced by means other than direct extraction from a native (non engineered) biological source’’ Synonyms: biotechnology products, biotechnology medicines, products of pharmaceutical biotechnology The definition includes: recombinant proteins, recombinant antibodies, gene therapy products, antisense oligonucleotides Recombinant technology started in the seventies, today, there are 100 products approved around the world.

First generation biopharmaceuticals Generally replacement proteins: proteins displaying an identical amino acid sequence to a native human protein and administered in order to replace or augment levels of that protein. e.g. recombinant forms of human insulin, growth hormone and blood factors. Second generation biopharmaceuticals Engineered proteins Protein engineering (site directed mutagenesis): the controlled alteration of a gene’s nucleotide sequence, such that specific pre-determined alterations in the resultant polypeptide’s amino acid sequence are introduced. Used to tailor the functional attributes of commercially important proteins. Objectives, (a) alteration of the protein’s mmunogenicity; (b) alteration of biological half life; (c) generation of faster/slower acting product; and (d) the generation of novel hybrid/synthetic therapeutic proteins

Engineered Insulins Engineered antibodies Hybridoma, murine source: HAMA response Humanized antibodies (chimaeric) Post translational engineering Covalent attachment of a chemical group (PEG and increased half life) Alteration in glycosylation pattern

Future trends Alternative production systems: Escherichia Coli, Saccharomoycese cerevisae, animal cell lines (CHO) Alternative delivery Nucleic acid based therapeutics: gene therapy, antisesne oligonucleotides Stem cell based therapy