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Impact of the WHO websiteon the regulatory control
of snake antivenom
Wichuda JARIYAPANInstitute of Biological products
Dept. of Medical SciencesMinistry of Public Health, Thailand
14th ICDRA Singapore
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Definition of Biologicals (WHO) Biological sources
Crude, semi purified extracts or purified fractions of microbial, animal or human tissues
Produced by biological processesTraditional/ Recombinant DNA/ Other biological technologies
Complex molecular structureCannot be characterized by physicochemical criteria alone
Biological assay
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A - Collection of venoms
B – Horse ImmunizationProtocols
C – Starting material of animal derived sera
D – Fractionation &Purification process
POOR QUALITY AND POOR REGULATORY CONTROL: Technology in the public domain
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Information to evaluate..
snake species –venoms horses: health care programme, vaccination, antibiotic usedimmunization programme
Hyperimmune plasma collection & storage, Potency titer …
Fractionation & purification processQC testing
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WHO Website for snake antivenoms
ANIMAL DERIVED BLOOD PRODUCTS
WHO Guidelines on production, control and regulation of snake antivenom immunoglobulin
WHO Database: clinically important venomous snakes species and its worldwide geographical distribution together with antivenoms for treatment of snakebite envenoming
WHO website hosting both the Guidelines and database (maps, pictures, products, manufacturers)
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Thai snake antivenoms
- 2 SAV manufacturers:- 7 products (monovalent
antivenoms)
How these preparations are controlled in Thailand?
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WHO critical control functions
- GMP - Marketing authorization- Lot release
WHO, Thai Pharmacopoeia
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WHAT IF..???? ....have limit knowledge/ experience regarding snakes, venomsdo not familiar with SAV…
import the products with/without registration
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The challenges for regulatorsWhere to get the specific SAVWhat information we need: snake species, neutralizing efficacy,safety, clinical data, PMS etc.How to evaluate the information
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WHO Guidelines
WHO Database: Medically Important Snakes Distribution maps, pictures & antivenoms
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Contents on website
Snake photo gallery – by regionsManufacturers – worldwide
Product listSnake giving venom
Unique website as a tool…
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In conclusion..
Not only the name on the label.. but also the content inside...
THANK YOU