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GMP issues for recombinant plant-derived pharmaceutical proteins

Paper ID Volume ID Publish Year Pages File Format Full-Text
14381 1214 2012 6 PDF Available
Title
GMP issues for recombinant plant-derived pharmaceutical proteins
Abstract

Recombinant proteins can be produced in a diverse array of plant-based systems, ranging from whole plants growing in the soil to plant suspension cells growing in a fully-defined synthetic medium in a bioreactor. When the recombinant proteins are intended for medical use (plant-derived pharmaceutical proteins, PDPs) they fall under the same regulatory guidelines for manufacturing that cover drugs from all other sources, and when such proteins enter clinical development this includes the requirement for production according to good manufacturing practice (GMP). In principle, the well-characterized GMP regulations that apply to pharmaceutical proteins produced in bacteria and mammalian cells are directly transferrable to plants. In practice, the cell-specific terminology and the requirement for a contained, sterile environment mean that only plant cells in a bioreactor fully meet the original GMP criteria. Significant changes are required to adapt these regulations for proteins produced in whole-plant systems and it is only recently that the first GMP-compliant production processes using plants have been delivered.

Keywords
GMP; Pharmaceuticals; Plants; Biopharmaceuticals; Platform development
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GMP issues for recombinant plant-derived pharmaceutical proteins
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Publisher
Database: Elsevier - ScienceDirect
Journal: Biotechnology Advances - Volume 30, Issue 2, March–April 2012, Pages 434–439
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us