NSTL国家科技图书文献中心

1. Biosimilars and immunogenicity: a matter of concern? NSTL国家科技图书文献中心

Jarab, Anan S. | Abu Heshmeh, Shrouq ...... - 《Expert opinion on drug safety》 - 2025,24(5) - 519～527 - 共9页

摘要： immunogenicity of biosimilars and discusses the regulatory | immunogenicity on therapeutic efficacy and patient | capture long-term immunogenicity* data effectively. It* | IntroductionBiosimilars have transformed | treatment modalities across various medical fields such as

关键词： Biosimilars | immunogenicity | safety issues | regulatory issues | drug safety

2. Beyond Efficacy: Ensuring Safety in Peptide Therapeutics through Immunogenicity Assessment NSTL国家科技图书文献中心

Achilleos, Koulla | Petrou, Christos ... - 《Journal of peptide science》 - 2025,31(6) - n/a～n/a - 共10页

摘要： therapeutics or biologics is immunogenicity, defined as an | impurity levels and immunogenicity. The development and | critical evaluation of appropriate immunogenicity* assays* | . Moreover, immunogenicity* testing is expected to remain a* | Peptides are gaining remarkable popularity in

关键词： ADAs | green chemistry | immunogenicity assessment | impurities | peptides

3. Statistical Tutorial for Cut‐Point Determination in Immunogenicity Studies NSTL国家科技图书文献中心

Yulia Mordashova | Xin Huang - 《Pharmaceutical statistics.》 - 2025,24(3) - e70016～e70016 - 共20页

摘要： of Immunogenicity* and the ability to follow* | areas. In order to assess the immunogenicity* of* | immunogenicity topics (immunoassays) cover the development and | more robust immunogenicity* assessments in clinical* | ABSTRACT Administration of therapeutic protein

关键词： ADA assay cut‐point estimation | ADA assay validation | immunogenicity

4. Host cell protein-mediated adjuvanticity and immunogenicity risks of biotherapeutics NSTL国家科技图书文献中心

Panikulam, Sherin | Morgan, Hannah ... - 《Biotechnology Advances》 - 2025,81 - Article 108575～Article 108575 - 共11页

摘要： include adjuvanticity and immunogenicity* with potential* | as adjuvants increasing the immunogenicity* of the* | immunogenicity against themselves, resulting in antiHCP T cell | immunogenicity potential of HCPs. A risk-based assessment of | Host cell proteins (HCPs) are process-related

关键词： Biotherapeutics | Host cell proteins | Monoclonal antibody | Adjuvanticity | Immunogenicity | Cross-reactivity

5. The changes necessary in the assessment of immunogenicity for the development of Biosimilars NSTL国家科技图书文献中心

Poetzl, Johann - 《Bioanalysis》 - 2025,17(5/6) - 355～358 - 共4页

摘要：Immunogenicity knowledge and the analytical | Reference. Within Immunogenicity* Risk Assessment for* | Biosimilars, in silico and in vitro immunogenicity | Biosimilar development. An ISI including an Immunogenicity | immunogenicity in conjunction with analytical and clinical data

关键词： Biosimilars | Immunogenicity Risk Assessment | in silico and in vitro immunogenicity assessment | integrated summary of immunogenicity | signal-to-noise ratio | singlicate sample analysis

6. Enhanced immunogenicity of a BoHV-1 gG-/tk- vaccine NSTL国家科技图书文献中心

Zhang, Sen | Liu, Guoxing ... - 《Vaccine》 - 2025,47 - Article 126704～Article 126704 - 共8页

摘要： and superior immunogenicity* compared to existing* | Bovine herpesvirus type 1 (BoHV-1) is a | widespread respiratory infection that significantly impacts | cattle health worldwide. To address this issue in China | , we previously developed a novel double gene-deleted

关键词： BoHV-1 | Gene-deleted vaccine | Inactivated BoHV-1 vaccine | Immunogenicity

7. A Meta-Analysis of the Safety and Immunogenicity of Pharmacokinetic Similarity Studies and Comparative Clinical Studies NSTL国家科技图书文献中心

Ji, Ping | Schrieber, Sarah J.... - 《Journal of clinical pharmacology.》 - 2025,65(4) - 499～507 - 共9页

摘要： studies assess safety and immunogenicity, it is | of the safety and immunogenicity* data from* | valuable information for comparing the immunogenicity* and* | A biosimilar clinical development program | generally includes a pharmacokinetic similarity study and

关键词： biosimilarity | comparative clinical study | immunogenicity | pharmacokinetic similarity study | safety

8. Exploring the role of cationic lipids in modulating immunogenicity and vaccine efficacy of mRNA-LNP NSTL国家科技图书文献中心

Zhou, Yan | Shan, Xiangfei ... - 《Particuology》 - 2025,97 - 共11页

摘要： excessive immunogenicity, have demonstrated potential in | enhance immunogenicity* without requiring new lipid* | immunogenicity, expanding the potential applications of mRNA | The mRNA vaccines have become a transformative | platform in medicine, with their success during the COVID

关键词： Lipid nanoparticle | mRNA vaccine | Immunogenicity | Cationic lipids | Immune response

9. Immunogenicity and safety of live attenuated influenza vaccine in children aged 3-17 years in China NSTL国家科技图书文献中心

Ai, Lizhe | Gao, Zhao ... - 《Vaccine》 - 2025,46 - Article 126653～Article 126653 - 共9页

摘要：. However, LAIV immunogenicity* in children aged 3-17 years* | the immunogenicity* and safety of the LAIV under a* | evaluate immunogenicity* and safety, respectively. (3* | (1) Background: The administration of a live | attenuated influenza vaccine (LAIV) has emerged as a viable

关键词： Live attenuated influenza vaccine (LAIV) | Immunogenicity | Safety | Children

10. The Immunogenicity of Coxsackievirus A6 (D3a Sub‐Genotype) Virus‐Like Particle and mRNA Vaccines NSTL国家科技图书文献中心

Huanhuan Lu | Jinbo Xiao ... - 《Journal of Medical Virology》 - 2025,97(2) - e70201～e70201 - 共15页

摘要： immunogenicity and protective effects of the VLP of CVA6 | experiments. The immunogenicity* and protective effects of* | worldwide and the first comparison of the immunogenicity | ABSTRACT In recent years, coxsackievirus A6 | (CVA6) has surpassed enterovirus A71 to become the

摘要： immunogenicity of biosimilars and discusses the regulatory | immunogenicity on therapeutic efficacy and patient | capture long-term immunogenicity* data effectively. It* | IntroductionBiosimilars have transformed | treatment modalities across various medical fields such as

关键词： Biosimilars | immunogenicity | safety issues | regulatory issues | drug safety

摘要： therapeutics or biologics is immunogenicity, defined as an | impurity levels and immunogenicity. The development and | critical evaluation of appropriate immunogenicity* assays* | . Moreover, immunogenicity* testing is expected to remain a* | Peptides are gaining remarkable popularity in

关键词： ADAs | green chemistry | immunogenicity assessment | impurities | peptides

摘要： of Immunogenicity* and the ability to follow* | areas. In order to assess the immunogenicity* of* | immunogenicity topics (immunoassays) cover the development and | more robust immunogenicity* assessments in clinical* | ABSTRACT Administration of therapeutic protein

关键词： ADA assay cut‐point estimation | ADA assay validation | immunogenicity

摘要： include adjuvanticity and immunogenicity* with potential* | as adjuvants increasing the immunogenicity* of the* | immunogenicity against themselves, resulting in antiHCP T cell | immunogenicity potential of HCPs. A risk-based assessment of | Host cell proteins (HCPs) are process-related

关键词： Biotherapeutics | Host cell proteins | Monoclonal antibody | Adjuvanticity | Immunogenicity | Cross-reactivity

摘要：Immunogenicity knowledge and the analytical | Reference. Within Immunogenicity* Risk Assessment for* | Biosimilars, in silico and in vitro immunogenicity | Biosimilar development. An ISI including an Immunogenicity | immunogenicity in conjunction with analytical and clinical data

关键词： Biosimilars | Immunogenicity Risk Assessment | in silico and in vitro immunogenicity assessment | integrated summary of immunogenicity | signal-to-noise ratio | singlicate sample analysis

摘要： and superior immunogenicity* compared to existing* | Bovine herpesvirus type 1 (BoHV-1) is a | widespread respiratory infection that significantly impacts | cattle health worldwide. To address this issue in China | , we previously developed a novel double gene-deleted

关键词： BoHV-1 | Gene-deleted vaccine | Inactivated BoHV-1 vaccine | Immunogenicity

摘要： studies assess safety and immunogenicity, it is | of the safety and immunogenicity* data from* | valuable information for comparing the immunogenicity* and* | A biosimilar clinical development program | generally includes a pharmacokinetic similarity study and

关键词： biosimilarity | comparative clinical study | immunogenicity | pharmacokinetic similarity study | safety

摘要： excessive immunogenicity, have demonstrated potential in | enhance immunogenicity* without requiring new lipid* | immunogenicity, expanding the potential applications of mRNA | The mRNA vaccines have become a transformative | platform in medicine, with their success during the COVID

关键词： Lipid nanoparticle | mRNA vaccine | Immunogenicity | Cationic lipids | Immune response

摘要：. However, LAIV immunogenicity* in children aged 3-17 years* | the immunogenicity* and safety of the LAIV under a* | evaluate immunogenicity* and safety, respectively. (3* | (1) Background: The administration of a live | attenuated influenza vaccine (LAIV) has emerged as a viable

关键词： Live attenuated influenza vaccine (LAIV) | Immunogenicity | Safety | Children

摘要： immunogenicity and protective effects of the VLP of CVA6 | experiments. The immunogenicity* and protective effects of* | worldwide and the first comparison of the immunogenicity | ABSTRACT In recent years, coxsackievirus A6 | (CVA6) has surpassed enterovirus A71 to become the

关键词： coxsackievirus A6 | immunogenicity | mRNA vaccine | protective effects | virus‐like particle

4008-161-200 800-990-8900

国家科技图书文献中心

摘要： immunogenicity of biosimilars and discusses the regulatory | immunogenicity on therapeutic efficacy and patient | capture long-term immunogenicity data effectively. It | IntroductionBiosimilars have transformed | treatment modalities across various medical fields such as

关键词： Biosimilars | immunogenicity | safety issues | regulatory issues | drug safety

摘要： therapeutics or biologics is immunogenicity, defined as an | impurity levels and immunogenicity. The development and | critical evaluation of appropriate immunogenicity assays | . Moreover, immunogenicity testing is expected to remain a | Peptides are gaining remarkable popularity in

关键词： ADAs | green chemistry | immunogenicity assessment | impurities | peptides

摘要： of Immunogenicity and the ability to follow | areas. In order to assess the immunogenicity of | immunogenicity topics (immunoassays) cover the development and | more robust immunogenicity assessments in clinical | ABSTRACT Administration of therapeutic protein

关键词： ADA assay cut‐point estimation | ADA assay validation | immunogenicity

摘要： include adjuvanticity and immunogenicity with potential | as adjuvants increasing the immunogenicity of the | immunogenicity against themselves, resulting in antiHCP T cell | immunogenicity potential of HCPs. A risk-based assessment of | Host cell proteins (HCPs) are process-related

关键词： Biotherapeutics | Host cell proteins | Monoclonal antibody | Adjuvanticity | Immunogenicity | Cross-reactivity

摘要：Immunogenicity knowledge and the analytical | Reference. Within Immunogenicity Risk Assessment for | Biosimilars, in silico and in vitro immunogenicity | Biosimilar development. An ISI including an Immunogenicity | immunogenicity in conjunction with analytical and clinical data

关键词： Biosimilars | Immunogenicity Risk Assessment | in silico and in vitro immunogenicity assessment | integrated summary of immunogenicity | signal-to-noise ratio | singlicate sample analysis

摘要： and superior immunogenicity compared to existing | Bovine herpesvirus type 1 (BoHV-1) is a | widespread respiratory infection that significantly impacts | cattle health worldwide. To address this issue in China | , we previously developed a novel double gene-deleted

关键词： BoHV-1 | Gene-deleted vaccine | Inactivated BoHV-1 vaccine | Immunogenicity

摘要： studies assess safety and immunogenicity, it is | of the safety and immunogenicity data from | valuable information for comparing the immunogenicity and | A biosimilar clinical development program | generally includes a pharmacokinetic similarity study and

关键词： biosimilarity | comparative clinical study | immunogenicity | pharmacokinetic similarity study | safety

摘要： excessive immunogenicity, have demonstrated potential in | enhance immunogenicity without requiring new lipid | immunogenicity, expanding the potential applications of mRNA | The mRNA vaccines have become a transformative | platform in medicine, with their success during the COVID

关键词： Lipid nanoparticle | mRNA vaccine | Immunogenicity | Cationic lipids | Immune response

摘要：. However, LAIV immunogenicity in children aged 3-17 years | the immunogenicity and safety of the LAIV under a | evaluate immunogenicity and safety, respectively. (3 | (1) Background: The administration of a live | attenuated influenza vaccine (LAIV) has emerged as a viable

关键词： Live attenuated influenza vaccine (LAIV) | Immunogenicity | Safety | Children

摘要： immunogenicity and protective effects of the VLP of CVA6 | experiments. The immunogenicity and protective effects of | worldwide and the first comparison of the immunogenicity | ABSTRACT In recent years, coxsackievirus A6 | (CVA6) has surpassed enterovirus A71 to become the

关键词： coxsackievirus A6 | immunogenicity | mRNA vaccine | protective effects | virus‐like particle

4008-161-200 800-990-8900

国家科技图书文献中心

摘要： immunogenicity of biosimilars and discusses the regulatory | immunogenicity on therapeutic efficacy and patient | capture long-term immunogenicity* data effectively. It* | IntroductionBiosimilars have transformed | treatment modalities across various medical fields such as

摘要： therapeutics or biologics is immunogenicity, defined as an | impurity levels and immunogenicity. The development and | critical evaluation of appropriate immunogenicity* assays* | . Moreover, immunogenicity* testing is expected to remain a* | Peptides are gaining remarkable popularity in

摘要： of Immunogenicity* and the ability to follow* | areas. In order to assess the immunogenicity* of* | immunogenicity topics (immunoassays) cover the development and | more robust immunogenicity* assessments in clinical* | ABSTRACT Administration of therapeutic protein

摘要： include adjuvanticity and immunogenicity* with potential* | as adjuvants increasing the immunogenicity* of the* | immunogenicity against themselves, resulting in antiHCP T cell | immunogenicity potential of HCPs. A risk-based assessment of | Host cell proteins (HCPs) are process-related

摘要：Immunogenicity knowledge and the analytical | Reference. Within Immunogenicity* Risk Assessment for* | Biosimilars, in silico and in vitro immunogenicity | Biosimilar development. An ISI including an Immunogenicity | immunogenicity in conjunction with analytical and clinical data

摘要： and superior immunogenicity* compared to existing* | Bovine herpesvirus type 1 (BoHV-1) is a | widespread respiratory infection that significantly impacts | cattle health worldwide. To address this issue in China | , we previously developed a novel double gene-deleted

摘要： studies assess safety and immunogenicity, it is | of the safety and immunogenicity* data from* | valuable information for comparing the immunogenicity* and* | A biosimilar clinical development program | generally includes a pharmacokinetic similarity study and

摘要： excessive immunogenicity, have demonstrated potential in | enhance immunogenicity* without requiring new lipid* | immunogenicity, expanding the potential applications of mRNA | The mRNA vaccines have become a transformative | platform in medicine, with their success during the COVID

摘要：. However, LAIV immunogenicity* in children aged 3-17 years* | the immunogenicity* and safety of the LAIV under a* | evaluate immunogenicity* and safety, respectively. (3* | (1) Background: The administration of a live | attenuated influenza vaccine (LAIV) has emerged as a viable

摘要： immunogenicity and protective effects of the VLP of CVA6 | experiments. The immunogenicity* and protective effects of* | worldwide and the first comparison of the immunogenicity | ABSTRACT In recent years, coxsackievirus A6 | (CVA6) has surpassed enterovirus A71 to become the