3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report

• Published in: Biologicals 2023-08, Vol.83, p.101695, Article 101695
• Main Authors: Viviani, Laura, Balks, Elisabeth, Beken, Sonja, Brady, Anna-Maria, Clayton, Rick, Cliquet, Florence, Desmayanti, Liys, Fragoeiro, Silvia, Hamtak, Terrie Jo, John, David, Jungbaëck, Carmen, Kalaivani, M., Kross, Imke, Lang, Catherine, Ria Isriyanthi, Ni Made, Mallet, Laurent, Milne, Catherine, Rubbrecht, Michelle, Siklódi, Botond, Singh, Brajesh, Srinivas, Geetha B., Stickings, Paul, Stirling, Catrina, Sundram, Pushpanathan, Szabó, Mária, Thomas, Anne, van den Berg, Mariette, Walker, Angela, Philippe, Corinne, Vandeputte, Joris
• Format: Article
• Language: English
• Subjects: 3Rs; Animal biology; Batch-release testing; Biologicals; Life Sciences; Non-animal testing; Quality control; Vaccines; Veterinary medicine and animal Health
• ISSN: 1045-1056; 1095-8320; 1095-8320
• DOI: 10.1016/j.biologicals.2023.101695

Regulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled “3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-art and future opportunities” was jointly organized by the Animal-Free Safety Assessment Collaboration, HealthforAnimals, and the International Alliance of Biological Standardization. Two webinars and a workshop aimed to outline the state-of-the-art non-animal approaches for veterinary batch-release testing. The events included information on the state of the deletion of obsolete safety testing and the current initiatives implemented by European, North American, and Asian-Pacific stakeholders on 3Rs implementation and regulatory acceptance. The events contributed to a better understanding of the barriers to 3Rs implementation. Participants highlighted the need for open communication, continued collaboration between stakeholders, and international harmonization of regulatory requirements to help accelerate acceptance. Despite the challenges, the countries represented at this three-part event have shared their commitments to advancing the acceptance of alternative methods. •Animal-based assays suffer from inherently high variability, resulting in relatively poor discriminative power.•Validated in vitro alternatives have proven consistency, reliability, and reduced Quality Control (QC) time.•New and evolving vaccine platform technologies make it possible to use in vitro QC testing from the start.•Communication and collaboration between stakeholders are paramount for the acceptance of non-animal methods and international harmonization of regulatory requirements will help to accelerate acceptance.•Despite challenges, Low- and Middle-Income Countries (LMIC) are committed to advancing the acceptance of alternative methods.