Industrial Production and Quality Control of Snake Antivenoms

León, Guillermo; Segura, Álvaro; Gómez, Aarón; Hernández, Andrés; Navarro, Diego; Villalta, Mauren; Vargas, Mariángela; Herrera, María; Gutiérrez, José Marı́a

doi:10.1007/978-94-007-6416-3_24

Cited by 9 publications

(16 citation statements)

References 43 publications

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“…Since the majority of manufacturers only test their antivenom batches against in-house reference preparations, it is difficult to compare antivenoms on a national, or even international level, and for buyers to get an idea of what an ideal product should consist of. Nonetheless, the use of in-house reference preparations may be a first step towards generation of national reference preparations (20). In accordance with our results from the manufacturer survey, 90% (n= 9) of the NHAs surveyed said that they had no national reference preparations of snake venom or antivenoms available, with the exception of one.…”

Section: Use Of Reference Preparationssupporting

confidence: 83%

“…One of the main challenges within the global antivenom market is the production and trade of suboptimal antivenom preparations (7,12,20). Snake antivenoms are currently not prequalified by the WHO, allowing manufacturers to dispatch products as they see fit.…”

Section: Quality Control Of Antivenomsmentioning

confidence: 99%

“…Due to inter-and intraspecies specificities in venom composition, a key aspect in antivenom quality control lies in the evaluation of the neutralizing capacity of antivenoms for the venoms of snakes in a specific country or region (7,18,20). The WHO guidelines provide detailed methodologies of preclinical efficacy tests that are necessary to ensure the neutralizing efficacy of antivenoms for specific snake species, however it is unknown whether manufacturers have been able to follow all these recommendations (7,18,20). The lack of national and international regulation of antivenoms results in suboptimal products being made available on the market (11).…”

Section: Quality Control Of Antivenomsmentioning

confidence: 99%

“…Antivenoms are not universally effective, creating a need to produce antivenoms for different snake immunotypes, which are inter-and intra-species specific (7,20). Only 33% (n= 2) of the manufacturer respondents indicated that they produce antivenoms for all medically important snakes in their countries.…”

Section: Antivenoms For Different Snake Speciesmentioning

confidence: 99%

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Needs and availability of snake antivenoms: relevance and application of international guidelines

Scheske

Ruitenberg

Bissumbhar

2015

Int J Health Policy Manag

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Background: Snakebite has recently been declared a global public health emergency. Empirical data showing the true burden of snakebite is lacking. Treatment with specific antivenoms is considered the only cure. However, several factors have led to an ongoing antivenom crisis. This study offers recommendations concerning the improvement of antivenom access and control, by providing an overview of the factors limiting the successful implementation of international guidelines within the international industry and state institutions. It further investigates the reasons for the epidemiological knowledge gap regarding snakebites. Methods: Data for this study was collected using surveys with closed-and open-ended questions, which allowed for descriptive and thematic analysis, respectively. Participants for this study were selected as follows: 46 manufacturers were contacted from the open-access World Health Organization (WHO) Database for antivenom producers; 23 National Health Authorities (NHAs) of high-burden countries were contacted; and 11 poison centers or experts were randomly contacted. Results: In total, responses from 6/46 (13%) manufacturers, 10/23 (43%) NHAs, and 3/11 (27%) poison centers were received. The low response rates had a limiting effect on the coverage of this study, allowing only exploratory conclusions to be drawn. Based on the gathered information, a probable reason for the epidemiological knowledge gap is the low priority given to snakebites on public health agendas, driving interest and funding away from research in this field. As a consequence, the ensuing lack in funding is preventing state institutions and manufacturers from implementing international guidelines to the highest standards. Furthermore, manufacturers indicated that international guidelines were often not applicable in the field, lacking technical information and protocols. Conclusion: Snakebite ranks low on international public health agendas, and partially due to this low priority, NHAs have shown limited efforts in conducting epidemiological studies, training health workers on snakebite management and creating national snakebite management strategies. The lack of NHA involvement is reflected in poor access to appropriate antivenoms as well as a lack of antivenom regulation. Manufacturers are taking positive steps toward full implementation of international guidelines and are improving quality control procedures. However, in order for international guidelines to become truly useful in the field, more technical guidance is required. This study reflects that there is a general lack of knowledge transfer amongst various actors: most producers, health authorities, and experts expect increased and improved communication and guidance from leading international bodies. Due to the low response rates observed in this study, conclusions drawn herein are not representative of the global situation; yet provide an exploratory insight on the difficulties facing antivenom management. Keywords: Snakebite, Antivenom, Envenomation, Gu...

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Section: Use Of Reference Preparationssupporting

confidence: 83%

Section: Quality Control Of Antivenomsmentioning

confidence: 99%

Section: Quality Control Of Antivenomsmentioning

confidence: 99%

Section: Antivenoms For Different Snake Speciesmentioning

confidence: 99%

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Needs and availability of snake antivenoms: relevance and application of international guidelines

Scheske

Ruitenberg

Bissumbhar

2015

Int J Health Policy Manag

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“…Of most the fractionation methods utilized in industrial production of antivenoms, the most reliable is affinity chromatography [20]. It is often demonstrated that immunochemically pure antibody with a 10-12 fold improvement in potency might be acquired with a single phase of affinity chromatography [21].…”

Section: Improvement Of Purification Methods For F(ab´)2 Fraction Of mentioning

confidence: 99%

Improvement of purification methods for F(ab')2 fraction of equine hyperimmune plasma against scorpion venom

Kordzangene¹,

Mohebat²,

Mosslemin³

et al. 2018

biomedicalresearch

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Antivenoms used for treatment of envenomation caused by like snakes and scorpions, are mostly produced in equine (horses) or ovine (sheep and goat). In Iran, the production of polyspecific scorpion antivenom has been started since 70 y ago and purified with ammonium sulfate fractionation after pepsin digestion of Fc fragment from IgG. Since this conventional method is time consuming, expensive and the product has lower purity. In this study we used either caprilic acid (Octatonic acid) alone or with combination with ammonium sulfate for separation and removal of impurities and precipitation of specific F(ab´) 2 against scorpion venom. Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis (SDS-PAGE) showed that purification with caprilic acid at a final concentration of 3.5% is optimal to obtain immunoglobulins essentially free of albumin. The second method of purification includes combination of 1.5% (v/v) caprilic acid with 20% saturation with ammonium sulfate. Both procedures are performed after peptic digestion of IgG (removal of Fc fragment) at 37°C for 4 h at pH=3.5. After peptic digestion pH is raised to 4.8 with 1.5 molar sodium hydroxide to stop enzyme digestion then in the first method 3.5-5% caprilic acid was added with strong agitation for one hour the impurities were removed with filter paper and the supernatant was dialyzed against CIS buffer. In the second method after adjusting pH=4.8 ammonium sulfate was added to 20% saturation then 1.5% caprilic acid was added with strong agitation for one hour then slurry is passed through filter paper the precipitated impurities discarded and supernatant was dialyzed.

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Morphological alterations caused by manual venom extraction on the main venom gland of Bothrops asper and Crotalus simus snakes (Serpentes: Viperidae): Long-term implications for antivenom production

Rodríguez-Abarca

Corrales

Chacón

et al. 2019

Toxicon

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Industrial Production and Quality Control of Snake Antivenoms

Cited by 9 publications

References 43 publications

Needs and availability of snake antivenoms: relevance and application of international guidelines

Needs and availability of snake antivenoms: relevance and application of international guidelines

Improvement of purification methods for F(ab')2 fraction of equine hyperimmune plasma against scorpion venom

Morphological alterations caused by manual venom extraction on the main venom gland of Bothrops asper and Crotalus simus snakes (Serpentes: Viperidae): Long-term implications for antivenom production

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