TY  - JOUR
PY  - 2018//
TI  - Current technology for the industrial manufacture of snake antivenoms
JO  - Toxicon: Journal of the International Society on Toxinology
A1  - León, Guillermo
A1  - Vargas, Mariángela
A1  - Segura, Alvaro
A1  - Herrera, María
A1  - Villalta, Mauren
A1  - Sánchez, Andrés
A1  - Solano, Gabriela
A1  - Gómez, Aarón
A1  - Sánchez, Melvin
A1  - Estrada, Ricardo
A1  - Gutiérrez, José María
SP  - 63
EP  - 73
VL  - 151
IS  - 
N2  - Snake antivenoms are formulations of animal immunoglobulins used in the treatment of snakebite envenomation. The general scheme for producing snake antivenoms has undergone few changes since its development more than a century ago; however, technological innovations have been introduced in the manufacturing process. These medicines must comply with identity, purity, safety and efficacy profiles, as requested by the current Good Manufacturing Practices (GMPs) applied to modern biopharmaceutical drugs. Industrial production of snake antivenoms comprises several stages, such as: 1) production of reference venom pools, 2) production of hyperimmune plasma, 3) purification of the antivenom immunoglobulins, 4) formulation of the antivenom, 5) stabilization of the formulation, and 6) quality control of in-process and final products. In this work, a general review of the existing technology used for the industrial manufacture of snake antivenoms is presented.<br><br>Copyright © 2018. Published by Elsevier Ltd.<p />  <p>Language: en</p>
LA  - en
SN  - 0041-0101
UR  - http://dx.doi.org/10.1016/j.toxicon.2018.06.084
ID  - ref1
ER  -