Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement

Viviani, Laura; Halder, Marlies; Gruber, Marion F.; Bruckner, L; Cußler, Klaus; Sanyal, Gautam; Srinivas, Geetha; Goel, Sunil; Kaashoek, M.J.; Litthauer, Derek; Silva, Arthur Leonardo Lopes da; Sakanyan, E. I.; Aprea, Patricia; Jin, Hongtao; Vandeputte, Joris; Seidle, Troy; Yakunin, Dimitriy

doi:10.1016/j.biologicals.2019.10.007

Cited by 14 publications

(12 citation statements)

References 3 publications

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“…Halder reported on the progress achieved for veterinary vaccines [ 2 , 3 ]. Thus, European Pharmacopoeia deleted the LABST already in 1997 and the TABST in 2013.…”

Section: Animal Use and 3rsmentioning

confidence: 99%

“…Laura Viviani presented the efforts of the Humane Society International (HSI) and the activities initiated – promotion of global regulatory alignment for the deletion of the general safety test [ 3 ] and the use of non-animal based methods to replace the rabbit pyrogenicity test – through the engagement of key regulatory and industry stakeholders of various countries. Ms. Viviani also presented the project of a dedicated database for non-animal based methods, their implementation status and the current existing collaboration opportunities.…”

Section: Harmonization: Challenges and Opportunitiesmentioning

confidence: 99%

“…Such an effort, now more necessary than ever, can only be carried out through the open cooperation of all the stakeholders involved. The end result of such a cooperation ought to be a more harmonized vaccine sector, where regulations are as aligned as possible between countries/regions, where obsolete animal tests are expunged from pharmacopoeias and regulations, and where alternative methods are recognized and accepted as quality control instruments, which will enable the reduction time to market of vaccines and increased global access reducing costs [ 2 , 3 ]. The IABS Animal testing for vaccines - Implementing Replacement, Reduction and Refinement: Challenges and Priorities , held in Bangkok, Thailand, on 3–4 December 2019, was organized specifically to discuss the current status of the field, and offer an opportunity to multiple stakeholders to share and gather information, to collectively identify the key hurdles and develop a roadmap that would lead to a wider acceptance of alternative methods in lot release for human and animal vaccines.…”

Section: Introductionmentioning

confidence: 99%

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Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities

Akkermans

Chapsal²,

Coccia

et al. 2020

Biologicals

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Transition to in vitro alternative methods to in vivo in vaccine release testing and characterization, the implementation of the consistency approach, and a drive towards international harmonization of regulatory requirements are most pressing needs in the field of vaccines. It is critical for global vaccine community to work together to secure effective progress towards animal welfare and to ensure that vaccines of ever higher quality can reach the populations in need in the shortest possible timeframe. Advancements in the field, case studies, and experiences from Low and Middle Income Countries (LMIC) were the topics discussed by an international gathering of experts during a recent conference titled “ Animal Testing for Vaccines – Implementing Replacement, Reduction and Refinement: Challenges and Priorities ”. This conference was organized by the International Alliance for Biological Standardization (IABS), and held in Bangkok, Thailand on December 3 and 4 2019. Participants comprised stakeholders from many parts of the world, including vaccine developers, manufacturers and regulators from Asia, Europe, North America, Australia and New Zealand. In interactive workshops and vibrant panel discussions, the attendees worked together to identify the remaining barriers to validation, acceptance and implementation of alternative methods, and how harmonization could be promoted, especially for LMICs.

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“…Halder reported on the progress achieved for veterinary vaccines [ 2 , 3 ]. Thus, European Pharmacopoeia deleted the LABST already in 1997 and the TABST in 2013.…”

Section: Animal Use and 3rsmentioning

confidence: 99%

Section: Harmonization: Challenges and Opportunitiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities

Akkermans

Chapsal²,

Coccia

et al. 2020

Biologicals

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“…The Argentinian regulatory authority has removed innocuity test from the Pharmacopoeia for biologicals. In South Africa, the National Control Laboratory has eliminated the innocuity test from routine testing of vaccines for the purpose of lot release [ 18 ].…”

Section: Decisions Made By the National Regulatory Authorities And Phmentioning

confidence: 99%

“…In China, Japan and Russia, innocuity testing is still required in their Pharmacopoeia or Minimum Requirements for Biological Products as a safety test for the release of vaccines and biological products [ 18 , 20 , 21 ].…”

Section: Decisions Made By the National Regulatory Authorities And Phmentioning

confidence: 99%

Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products

Lei

Knežević

et al. 2020

Biologicals

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The innocuity test was indicated as a quality control test to release pharmaceutical and biological products to the market. The test was intended to detect possible extraneous toxic contaminants derived from the manufacturing processes of the product. The test was included in WHO Recommendations and Guidelines for vaccines, biotherapeutics and blood products and in some monographs on antibiotics in The International Pharmacopoeia . Over the past years, the requirements in WHO Recommendations/Guidelines for conducting the test evolved such that it could be waived for routine release of product once consistency of production was established to the satisfaction of the NRA, or that the need for this test should be discussed and agreed with the NRA. However, some users of WHO written standards for biologicals (i.e., Recommendations, Guidelines) and WHO specifications for pharmaceuticals (i.e ., The International Pharmacopoeia ) requested that the innocuity test be deleted from WHO written standards based on its lack of specificity and scientific relevance. In response to that request, we studied the history of this test and its use by the member states of WHO, and the recommendations in WHO written standards. The outcomes of the study were reviewed by the relevant WHO Expert Committee on Biological Standardization and Expert Committee on Specifications for Pharmaceutical Products who then decided to discontinue this test in WHO Recommendations for vaccines and biologicals and to omit the test from The International Pharmacopoeia .

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Microbial Dynamics and Quality Monitoring in Biopharmaceutical Production

Pashang,

Gilbride,

Wenk

2024

ChemBioEng Reviews

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Prokaryotic cells are pivotal in meeting the global demand for biopharmaceuticals. However, challenges such as the absence of advanced technology for real‐time monitoring, standardized testing methodologies, and quality risk assessment of microbial activity have led to increased production costs, delays, and shortages of biopharmaceutical products. A thorough understanding of how biomolecule production interacts with microbial population structure and function is vital for improving continuous manufacturing and process automation. In this review, we discuss the current microbiological techniques that meet good manufacturing practice requirements in industrial settings, explore the advantages of monitoring and measuring biomass growth efficiency and turnover rates beyond regulatory criteria for product release, and provide a critical assessment of the current state of knowledge on bioassays and engineering tools for biomolecule yield measurement and monitoring. Furthermore, we identify areas for future development, potential applications, and the need for interdisciplinary innovation to drive future research, including advancing bioassays for biopharmaceutical wastewater risk.

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Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement

Cited by 14 publications

References 3 publications

Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities

Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities

Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products

Microbial Dynamics and Quality Monitoring in Biopharmaceutical Production

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