AI Article Synopsis

  • Transgenic plants are being explored for producing pharmaceutical compounds, but face technological and regulatory challenges that limit commercial success.
  • The paper discusses the successful expression and purification of a single-chain antibody fragment and a monoclonal antibody for hepatitis B using transgenic plants.
  • It also addresses the necessary regulatory issues and technologies to ensure compliance with manufacturing and agricultural standards.

Article Abstract

The use of transgenic plants for the production of pharmaceutical compounds has received increasing attention in the last few years. However, many technological and regulatory issues regarding the practical exploitation of this alternative system of production remain to be solved; a situation that explains the lack of commercial products derived from such a system. This paper reports the expression in transgenic plants and cells of a single-chain antibody variable-region fragment (scFv) and a mouse monoclonal antibody to the hepatitis B virus surface antigen (HBsAg). The large-scale purification of the scFv from plants and its use for immunopurification of HBsAg are also described, together with elements concerning regulatory issues and technologies for compliance with good manufacturing and agricultural practices.

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Source
http://dx.doi.org/10.1016/j.vaccine.2004.11.023DOI Listing

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