Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report

Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states

“…As sterility and endotoxin tests have been used to determine product contamination, it was concluded that the removal of ATT would not have any negative impact on product safety. This conclusion is consistent with the practices in the United States, Canada, and Europe, where ATT is not required for quality testing of biological products [ 9 ]. The foregoing changes in the environment for NCL testing are considered accomplishments produced by regulatory science as they have led to the minimization of animal use in testing and the global harmonization of quality control criteria.…”

Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers

“…The most common test categories where animals are used consistently were potency (29.3%) followed by ATT/GST (20.5%), adventitious agents (11.2%), specific toxicity (11%) and pyrogen testing (9.3%). It is particularly interesting that the ATT/GST test is still widely used given that the WHO [ 4 ] and several National pharmacopeia [ 3 , [16] , [17] , [18] ] have deleted the requirement for this test from their guidelines. We specifically asked whether respondents were aware that the WHO had deleted the ATT/GST and nearly 80% indicated that they were aware of the decision of ECBS in 2018.…”

Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities

“…The ATT/GST test is still widely performed despite the fact that the WHO [ 4 ] and several national pharmacopeias [ 4 , 5 , 19 , 20 ] have deleted the requirement for this test from their guidelines. We specifically asked whether respondents were aware that the WHO had deleted the ATT/GST and 85 % (11/13) indicated that they were aware of the decision of ECBS in 2018.…”

“…The Abnormal Toxicity Test (ATT) (also referred to as the General Safety Test (GST) or test for innocuity) has been widely acknowledged as being scientifically questionable, non-reproducible and non-specific [ [3] , [4] , [5] ]. The WHO Expert Committee on Biological Standardization (ECBS) followed the United States of America Food and Drug Administration (FDA), the European Pharmacopeia (Ph Eur) and others in removing this test from their requirements in 2018 [ 6 ].…”