Recent developments and perspectives of biotechnology-derived products.
Recent advances in molecular biology especially in the area of rDNA, gene transfer, polymerase chain reaction and hybridoma techniques have provided the necessary molecular tools for the development of a new class of biopharmaceuticals. These biopharmaceuticals include antisense drugs, carbohydrate-based macromolecules and agents that interfere with apoptosis pathways. Cytokines and other immunomodulators also represent an exciting class of new therapeutic entities. The safety evaluation, efficacy, manufacturing and quality control of these complex biopharmaceuticals represent a challenge to the pharmacologist and toxicologist. Finally, the regulatory issues associated with the new biopharmaceuticals need to be addressed to insure the safety of these evolving therapeutic substances.
Thomas
J A
JA
Department of Pharmacology, University of Texas Health Science Center, San Antonio, USA.
D017209:Apoptosis / Q000187:drug effects; D001709:Biotechnology / Q000331:legislation & jurisprudence / Q000639:trends*; D002241:Carbohydrates / Q000096:biosynthesis; D016207:Cytokines / Q000494:pharmacology / Q000627:therapeutic use; D004274:DNA, Recombinant / Q000235:genetics*; D015195:Drug Design; D018014:Gene Transfer Techniques; D017408:Guidelines as Topic; D006825:Hybridomas; D016376:Oligonucleotides, Antisense / Q000096:biosynthesis / Q000592:standards; D016133:Polymerase Chain Reaction; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use; D012449:Safety
D002241:Carbohydrates; D016207:Cytokines; D004274:DNA, Recombinant; D016376:Oligonucleotides, Antisense; D011994:Recombinant Proteins