Results 1 to 10 of about 6,954,031 (249)

Development of an In Vitro Test Method to Replace an Animal-Based Potency Test for Pertactin Antigen in Multivalent Vaccines [PDF]

Vaccines, 2023
There is increasing interest to replace animal-based potency assays used routinely to test vaccines, since they are highly variable, are costly, and present ethical concerns. The development of relevant in vitro assays is part of the solution.
Jason Szeto, Aruun Beharry, Tricia Chen, Eric Zholumbetov, Emilie Daigneault, Marin Ming, Iain Lounsbury, Nelson Eng, Nemika Thangavadivel, Robbie Jin, Aurélie Denis-Jacquot, Bahram Behnam Azad, Meili Li, Diana Keizner, Marcus Liu, Sophia S. F. Lee, Kai He, Beata Gajewska   +17 more
doaj   +2 more sources

A versatile and GMP-compliant bead-based IFN-γ potency assay for standardized quality control and release testing of CAR-T cell drug products [PDF]

International Journal of Pharmaceutics: X
Potency is a critical specification for CAR-T cells and is typically determined by co-culture of CAR-T cells with target cell lines. However, cell line heterogeneity hampers standardization and can lead to analytical variation impacting potency test ...
Robin Dennebos, Macarena González-Corrales, Maria Lysandrou, Nienke A.M. Smit, Yuzhu Qi, Tom van Meerten, Jos G.W. Kosterink, Gerwin Huls, Harm-Jan Lourens, Bahez Gareb, Edwin Bremer   +10 more
doaj   +2 more sources

Advanced Cell Therapy product release containing CAR-T cells

Journal of Bone Marrow Transplantation and Cellular Therapy, 2022
Manufacturing of customized gene or cell therapy products  such as CAR-T cells is complex and depends on release tests and exams that can attest to a consistent quality standard for each product.
Juliana Preto de Godoy, Lucila Nassif Kerbauy, Raquel Melo Alves Paiva, Andrea Tiemi Kondo, Oswaldo Keith Okamoto, José Mauro Kutner   +5 more
doaj   +1 more source

Alternative potency tests for quality control of immunobiologicals: a critical review of the validation approach

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2020
Introduction: In addition to low reproducibility, in vivo potency tests used in the quality control of immunobiological products require too many animals, causing them significant pain and suffering.
Wildeberg Cal Moreira, Nathalia de Souza Machado, Jéssica Ferreira de Souza Freitas, Antônio Eugênio Castro Cardoso de Almeida, Wlamir Correa de Moura   +4 more
doaj   +7 more sources

Development of an ELISA-Based Potency Assay for Inactivated Influenza Vaccines Using Cross-Reactive Nanobodies

Vaccines, 2022
Inactivated vaccines are the main influenza vaccines used today; these are usually presented as split (detergent-disrupted) or subunit vaccines, while whole-virus-inactivated influenza vaccines are rare. The single radial immune diffusion (SRD) assay has
Chung Y. Cheung, Sitara Dubey, Martina Hadrovic, Christina R. Ball, Walter Ramage, Jacqueline U. McDonald, Ruth Harvey, Simon E. Hufton, Othmar G. Engelhardt   +8 more
doaj   +1 more source

Macrophage Activation Assays to Evaluate the Immunostimulatory Capacity of Avibacterium paragallinarum in A Multivalent Poultry Vaccine

Vaccines, 2020
High-quality vaccines are crucial to prevent infectious disease outbreaks in the poultry industry. In vivo vaccination tests are routinely used to test poultry vaccines for their potency, i.e., their capacity to induce protection against the targeted ...
Robin H. G. A. van den Biggelaar, Willem van Eden, Victor P. M. G. Rutten, Christine A. Jansen   +3 more
doaj   +1 more source

test

, 2023
testtes
test, test
core   +3 more sources

Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka

Vaccines, 2023
Seven brands of veterinary rabies vaccines are commercially available in Sri Lanka, but there is no established procedure to test the potency of the vaccines at the local level, especially prior to their release.
Hasanthi Rathnadiwakara, Mangala Gunatilake, Alexandre Servat, Marine Wasniewski, Jean-Christophe Thibault, Florence Cliquet   +5 more
doaj   +1 more source

Assay of Diphtheria Vaccine Potency by Intradermal Challenge Test

Эпидемиология и вакцинопрофилактика, 2023
Relevance. Modern identifying potency (immunogenicity) of diphtheria toxoid tests are based on determining immunized animals resistance for administration challenge toxin or evaluation of protective antibodies level in serum.
E. I. Komarovskaya, О. V. Perelygyna
doaj   +1 more source

Cross-Protection Induced by a A/MAY/97 Emergency Vaccine Against Intra-Serotype Heterologous Challenge with a Foot-and-Mouth Disease Virus from the A/ASIA/G-VII Lineage

Vaccines, 2020
Since 2015, outbreaks of foot-and-mouth disease (FMD) in the Middle East have been caused by a new emerging viral lineage, A/ASIA/G-VII. Invitro vaccine matching data indicated that this virus poorly matched (low r1-value) with vaccines that were being ...
Aldo Dekker, Beatriz Sanz-Bernardo, Nagendrakumar Balasubramanian Singanallur, Anna B. Ludi, Jacquelyn Horsington, Phaedra L. Eblé, Donald P. King, Wilna Vosloo   +7 more
doaj   +1 more source