Standardized guidelines for Africanized honeybee venom production needed for development of new apilic antivenom.
Ricardo de Oliveira OrsiRodrigo ZaluskiLuciana Curtolo de BarrosBenedito BarravieraDaniel Carvalho PimentaRui Seabra Ferreira JúniorPublished in: Journal of toxicology and environmental health. Part B, Critical reviews (2024)
Africanized bees have spread across the Americas since 1956 and consequently resulted in human and animal deaths attributed to massive attacks related to exposure from Argentina to the USA. In Brazil, more than 100,000 accidents were registered in the last 5 years with a total of 303 deaths. To treat such massive attacks, Brazilian researchers developed the first specific antivenom against Africanized honey bee sting exposure. This unique product, the first of its kind in the world, has been safely tested in 20 patients during a Phase 2 clinical trial. To develop the antivenom, a standardized process was undertaken to extract primary venom antigens from the Africanized bees for immunization of serum-producing horses. This process involved extracting, purifying, fractionating, characterizing, and identifying the venom (apitoxin) employing mass spectrometry to generate standardized antigen for hyperimmunization of horses using the major toxins (melittin and its isoforms and phospholipase A2). The current guide describes standardization of the entire production chain of venom antigens in compliance with good manufacturing practices (GMP) required by regulatory agencies. Emphasis is placed upon the welfare of bees and horses during this process, as well as the development of a new biopharmaceutical to ultimately save lives.
Keyphrases
- clinical trial
- mass spectrometry
- end stage renal disease
- newly diagnosed
- endothelial cells
- chronic kidney disease
- dendritic cells
- healthcare
- prognostic factors
- oxidative stress
- transcription factor
- liquid chromatography
- patient reported outcomes
- escherichia coli
- clinical practice
- induced pluripotent stem cells
- staphylococcus aureus
- phase ii
- pseudomonas aeruginosa
- biofilm formation
- study protocol
- patient reported
- simultaneous determination
- pluripotent stem cells