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2025
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OpenAlex
Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, Nicoletta Bivi et autres
The 19th Workshop on Recent Issues in Bioanalysis (19th WRIB) took place in New Orleans, LA, USA on April 7-11, 2025. Over 1200 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest …
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2025
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OpenAlex
Jianing Li, Heather Loryn Platt, Wen‐Yu Hu, Weifeng Xu et autres
Pneumococcal conjugate vaccines (PCVs) are designed to induce serotype-specific antibodies; however, antibodies raised against pneumococcal polysaccharides in the vaccine can also cross-react to other serotypes based on structural similarities. Cross-reactivity has been demonstrated for some licensed PCVs and is a worthy consideration …
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2025
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OpenAlex
Weifeng Xu, Joseph M. Antonello, Jennifer L. Nguyen, Chaoyang Ma et autres
BACKGROUND: The opsonophagocytic assay (OPA) is the gold standard for measuring functional antibody responses to bacterial vaccines. However, antibody-independent bactericidal activities, such as those by antibiotics, could contribute to the killing and thus inflate the measured antibody titer. Because of this, an …
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2025
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OpenAlex
Kyeongmi Cheon, Ulrike Kirsten Buchwald, Laura L. Hammitt, Jason J. LeBlanc et autres
To better inform pneumococcal immunization policies, ongoing surveillance for pneumococcal community-acquired pneumonia (CAP) is crucial. To estimate the serotype-specific CAP burden of pneumococcal disease following the introduction of a new 15-valent pneumococcal conjugate vaccine (PCV), V114, a 15-plex serotype-specific urine antigen detection …
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2025
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OpenAlex
Omar Tounekti, Sandra Prior, Sarah Wassmer, Joshua Xu et autres
The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest …
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2025
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OpenAlex
Joseph M. Antonello, Rocio D. Murphy, Chitrananda Abeygunawardana, Juliana C. Malinverni et autres
ABSTRACT Measuring the immunogenicity of pneumococcal vaccines involves the use of immunoassays to measure serotype-specific immunoglobulin G (IgG) antibody levels post-vaccination with the current Streptococcus pneumoniae human reference serum standard (007sp) for anti-pneumococcal capsule antibodies. Development of new pneumococcal conjugate vaccines (PCVs) …
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2024
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OpenAlex
Francis J. Dessy, Ivo Sonderegger, Leslie Wagner, Alessandra Buoninfante et autres
The urgency and importance of organizing a global effort to harmonize clinical assay validation specific to the vaccine industry was identified during the drafting of the 2020 White Paper in Bioanalysis due to the lack of clarity and regulatory guidance/guidelines in vaccine …
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2024
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OpenAlex
Johanna R. Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu et autres
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on June 19–23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in …
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2023
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Yaru Shi, Katrina M. Nolan, Robert L. Burton, Tulin Shekar et autres
Pneumococcal serogroups consist of structurally related serotypes, and serotype-specific antibodies can cross-react against other serotypes within the same serogroup. Cross-reactivity of vaccine-induced serotype 6A antibodies, and, to a lesser extent, serotype 6B antibodies, to serotype 6C has been demonstrated following receipt of …
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2023
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OpenAlex
Katrina M. Nolan, Brent L. Seaton, Joseph M. Antonello, Yuhua Zhang et autres
Assay modernization is a key aspect of vaccine life cycle management. Thus, new, reoptimized versions of two 9vHPV immunoassays have been developed and validated for use in ongoing and future HPV vaccine clinical trials. These assays are suitable for use in high-throughput …
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2023
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OpenAlex
Yaru Shi, Katrina M. Nolan, Robert L. Burton, Rocio D. Murphy et autres
Abstract Background Pneumococcal serotype 6C has structural similarity with serotype 6A and, to a lesser degree, serotype 6B. The 13-valent PCV (PCV13), which contains serotypes 6A and 6B, induces cross-reactive opsonophagocytic killing activity (OPA) antibodies to serotype 6C, with an observed decline …
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2022
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OpenAlex
Gowrisankar Rajam, Yuhua Zhang, Joseph M. Antonello, Rebecca J. Grant-Klein et autres
Streptococcus pneumoniae has more than 90 serotypes capable of causing a range of disease manifestations, including otitis media, pneumonia, and invasive diseases, such as bacteremia or meningitis. Only a minority (<10%) of pneumococcal diseases are bacteremic with known serotype distribution. Culture and …
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