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Author(s): Vipul P. Patel*1, Tushar R. Desai2,, Arjun S Dedakiya 3, Hemant M. Bandhiya3, Chetan R. Matholiya3, Riddhi M. Katira 3, Bindi G. Chavda 3

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 10;
Start page: 3673;
Date: 2011;
Original page

Keywords: Biologicals | Analytical method | Protein structure | Process and control | Potency/biological activity | Immunogenicity | Biotechnological Products

ABSTRACT
This article provides a basic view of what defines biological medicinal Products, often called biologicals, and how they differ from chemical products. In enteringinto this thought process, let us remember that proteins range in size from small amino acid chains up to macromolecules of hundreds of kilodaltons in size. Inaddition, in order to appreciate the science behind the regulations, an understanding of organic chemistry is necessary, and preferably knowledge of molecular cellbiology and how proteins are created in cells via the DNA expression mechanisms. Although the details are inevitably complex and specialist as a result, we will lookat some basic concepts pertinent to biologicals so that a regulatory generalist can be effective in dealing with such products.
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