Consideration of the Proteins and Peptides Produced by New Technology for use as Therapeutics
Proteins and peptides for use as therapeutics may be isolated and purified from appropriate natural sources, prepared by rDNA technology or chemically synthesized. In this report we shall address mainly our experiences in considering production, purification, and testing of biologicals derived from rDNA technology and briefly review available documents that relate to products produced by chemical synthesis. Regardless of the source of the proteins and peptides, ultimately it is the responsibility of the manufacturers to demonstrate consistency in the safety, potency, efficacy, and purity of their products.
KeywordsSynthetic Peptide Cell Substrate Continuous Cell Line Single Chained Protein Master Cell Bank
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