Biotechnology-derived products insulin

Biotechnology-derived products have led to renewed interest in establishing reference standards based on the same bulk of material. Thus a single formulation, assay, and reference standard may be the fact worldwide. This situation can become complex such as with insulin where both biotechnology-derived insulin and animal-source insulin are in the marketplace at the same time. 

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

Recombinant insulin was the first biotechnology product, which emerged in 1982. Today, biopharmaceutical products have diverged to encompass not only recombinant forms of natural proteins and biologicals derived from natural sources, including recombinant plant-derived pharmaceutical proteins, but also monoclonal antibody (mAb)-based therapeutics. All these products require special consideration from a regulatory point of view. 

Enzymes, proteins, antibodies, biologically active peptides and other protein derivatives have long been used in medicinal agents. Modem biotechnology opened horizons to create new processes and products. For example insulin, interferon and other medical proteins are now being produced commercially by genetic engineering. 

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