Freeze-dried EchiTAb+ICP antivenom formulated with sucrose is more resistant to thermal stress than the liquid formulation stabilized with sorbitol

Herrera, M, Segura, A, Sanchez, A, Sanchez, A, Vargas, M, Harrison, Robert, Gutierrez, JM and Leon, G (2017) 'Freeze-dried EchiTAb+ICP antivenom formulated with sucrose is more resistant to thermal stress than the liquid formulation stabilized with sorbitol'. Toxicon, Vol 133, pp. 123-126.

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Abstract

EchiTAb + ICP is a pan-African antivenom used for the treatment of snakebite envenomation in rural sub-Saharan African communities, where the cold chain can be difficult to maintain. To develop a formulation of EchiTAb + ICP that can be distributed and stored without refrigeration, we submitted three different formulations of EchiTAb + ICP: control (i.e. liquid antivenom formulated without stabilizer), liquid antivenom stabilized with sorbitol, and freeze-dried antivenom formulated with sucrose, to an accelerated stability study (i.e. 38 ± 2 °C and 75% relative humidity for 6 months). We analyzed changes in color, residual humidity, reconstitution time (for freeze-dried preparation), pH, osmolality, total protein concentration, antibody monomers content, turbidity, bacterial endotoxins, and pre-clinical neutralizing efficacy of the lethal effect of Echis ocellatus venom at 0, 3 and 6 months. In the control formulation, instability was evidenced by the development of a yellow coloration and an increment in aggregation and turbidity, without change in its neutralizing activity. The sorbitol-stabilized formulation did not develop marked aggregation or turbidity, but instability was evidenced by the development of yellow coloration and a drop in the neutralizing potency. The freeze-dried formulation maintained its neutralizing potency and did not show marked signs of instability, thus indicating that freeze-drying could confer EchiTAb + ICP with improved thermal stability required for distribution and storage at room temperature in sub-Saharan Africa.

Item Type:	Article
Additional Information:	Short Communication
Subjects:	QU Biochemistry > QU 4 General works QW Microbiology and Immunology > Environmental Microbiology > QW 55 Environmental microbiology QW Microbiology and Immunology > Antigens and Antibodies. Toxins and Antitoxins > QW 573 Antigens QW Microbiology and Immunology > Antigens and Antibodies. Toxins and Antitoxins > QW 630 Toxins. Antitoxins WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries
Faculty: Department:	Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):	https://doi.org/10.1016/j.toxicon.2017.05.006
Depositing User:	Mary Creegan
Date Deposited:	19 Jun 2017 13:05
Last Modified:	06 Feb 2018 13:14
URI:	https://archive.lstmed.ac.uk/id/eprint/7114

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