Biologicals最新文献_第3页

Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines 验证用于检测不定病毒的新一代测序方法：在多种细胞系中证明灵敏度。

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 DOI: 10.1016/j.biologicals.2024.101771

Rebecca A. Bova, Leyla Diaz, Scott Eubank, Amber Overgard, Alison Armstrong, Bradley Hasson

{"title":"Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines","authors":"Rebecca A. Bova, Leyla Diaz, Scott Eubank, Amber Overgard, Alison Armstrong, Bradley Hasson","doi":"10.1016/j.biologicals.2024.101771","DOIUrl":"10.1016/j.biologicals.2024.101771","url":null,"abstract":"<div><p>In the past few years NGS has become the technology of choice to replace animal-based virus safety methods and this has been strengthened by the recent revision to the ICHQ5A virus safety chapter. Here we describe the validation of an NGS method using an agnostic analysis to detect and identify RNA virus and actively replicating DNA virus contaminants in cell banks. We report the results of the validation of each step in the sequencing process that established quality criteria to ensure consistent sequencing data. Furthermore, the validation of the analysis algorithm designed to identify virus specific sequences is described along with steps undertaken to ensure the integrity of the sequencing data from generation to analysis. Lastly, the validated sequencing and analysis systems were used to establish a limit of detection (LOD) for model viruses in cells that are commonly used in biomanufacturing. The LOD from these studies ranged from 1E+03 to 1E+04 genome copies and were dependent on the virus type with little variability between the different cell types. Thus, the validation of the NGS method for adventitious agent testing and the establishment of a general LOD for cell-based samples provides a suitable alternative to traditional virus detection methods.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000289/pdfft?md5=597f955402c554c0175fd90d4e780160&pid=1-s2.0-S1045105624000289-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141066229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness 针对猴痘病毒的新型多表位混合疫苗的设计与计算评估：大流行准备工作的潜在目标和免疫原性评估。

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 DOI: 10.1016/j.biologicals.2024.101770

Allah Rakha Yaseen , Muhammad Suleman , Aqsa Jabeen , Laiba Nezami , Abdul Salam Qadri , Ayesha Arif , Iram Arshad , Khadija Iqbal , Tasuduq Yaqoob , Zoha Khan

{"title":"Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness","authors":"Allah Rakha Yaseen , Muhammad Suleman , Aqsa Jabeen , Laiba Nezami , Abdul Salam Qadri , Ayesha Arif , Iram Arshad , Khadija Iqbal , Tasuduq Yaqoob , Zoha Khan","doi":"10.1016/j.biologicals.2024.101770","DOIUrl":"10.1016/j.biologicals.2024.101770","url":null,"abstract":"<div><p>Monkeypox is a type of DNA-enveloped virus that belongs to the orthopoxvirus family, closely related to the smallpox virus. It can cause an infectious disease in humans known as monkeypox disease. Although there are multiple drugs and vaccines designed to combat orthopoxvirus infections, with a primary focus on smallpox, the recent spread of the monkeypox virus to over 50 countries have ignited a mounting global concern. This unchecked viral proliferation has raised apprehensions about the potential for a pandemic corresponding to the catastrophic impact of COVID-19. This investigation explored the structural proteins of monkeypox virus as potential candidates for designing a novel hybrid multi-epitope vaccine. The epitopes obtained from the selected proteins were screened to ensure their non-allergenicity, non-toxicity, and antigenicity to trigger T and B-cell responses. The interaction of the vaccine with toll-like receptor-3 (TLR-3) and major histocompatibility complexes (MHCs) was assessed using Cluspro 2.0. To establish the reliability of the docked complexes, a comprehensive evaluation was conducted using Immune and MD Simulations and Normal Mode Analysis. However, to validate the computational results of this study, additional in-vitro and in-vivo research is essential.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140946615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of skeletal muscle decellularization protocols and recellularization with adipose-derived stem cells for tissue engineering 比较用于组织工程的骨骼肌脱细胞方案和脂肪干细胞再细胞化方案

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 DOI: 10.1016/j.biologicals.2024.101767

Joyce Esposito , Pricila da Silva Cunha , Thaís Maria da Mata Martins , Mariane Izabella Abreu de Melo , Marcos Augusto de Sá , Dawidson Assis Gomes , Alfredo Miranda de Góes

{"title":"Comparison of skeletal muscle decellularization protocols and recellularization with adipose-derived stem cells for tissue engineering","authors":"Joyce Esposito , Pricila da Silva Cunha , Thaís Maria da Mata Martins , Mariane Izabella Abreu de Melo , Marcos Augusto de Sá , Dawidson Assis Gomes , Alfredo Miranda de Góes","doi":"10.1016/j.biologicals.2024.101767","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101767","url":null,"abstract":"<div><p>Decellularization is a novel technique employed for scaffold manufacturing, as a strategy for skeletal muscle (SM) tissue engineering applications. However, poor decellularization efficacy is still a problem for the use of decellularized scaffolds as truly biocompatible biomaterials. For recellularization, adipose-derived stem cells (ASCs) are a good option, due to their immunomodulatory and pro-regenerative capacity, but few studies have described their combination with muscle-decellularized matrices (mDMs). This work aimed to evaluate the efficiency of four multi-step decellularization protocols to produce mDMs and to investigate <em>in vitro</em> biocompatibility with ASCs. Here, we described the different efficacies of muscle decellularization methods, suggesting the need for stricter standardization of the method, considering the large range of applications in SM tissue engineering, which is also a promising platform for preclinical studies with rat disease models using autologous cells.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140823683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen 一种利用杆状病毒表达的重组核壳抗原检测人血清中抗 SARS-CoV-2 抗体的间接 ELISA 方法

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 DOI: 10.1016/j.biologicals.2024.101769

Matheus Bernardes Torres Fogaça , Gildemar José Bezerra Crispim , Djairo Pastor Saavedra , Leonardo Lopes-Luz , Leonardo Assis da Silva , Brenda Rabello de Camargo , Rafael Alves Guimarães , Tatsuya Nagata , Bergmann Morais Ribeiro , Samira Bührer-Sékula

{"title":"An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen","authors":"Matheus Bernardes Torres Fogaça , Gildemar José Bezerra Crispim , Djairo Pastor Saavedra , Leonardo Lopes-Luz , Leonardo Assis da Silva , Brenda Rabello de Camargo , Rafael Alves Guimarães , Tatsuya Nagata , Bergmann Morais Ribeiro , Samira Bührer-Sékula","doi":"10.1016/j.biologicals.2024.101769","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101769","url":null,"abstract":"<div><p>This study focuses on the development and initial assessment of an indirect IgG enzyme-linked immunosorbent assay (ELISA) specifically designed to detect of anti-SARS-CoV-2 antibodies. The unique aspect of this ELISA method lies in its utilization of a recombinant nucleocapsid (N) antigen, produced through baculovirus expression in insect cells. Our analysis involved 292 RT-qPCR confirmed positive serum samples and 54 pre-pandemic healthy controls. The process encompassed cloning, expression, and purification of the SARS-CoV-2 N gene in insect cells, with the resulted purified protein employed in our ELISA tests. Statistical analysis yielded an Area Under the Curve of 0.979, and the optimized cut-off exhibited 92 % sensitivity and 94 % specificity. These results highlight the ELISA's potential for robust and reliable serological detection of SARS-CoV-2 antibodies. Further assessments, including a larger panel size, reproducibility tests, and application in diverse populations, could enhance its utility as a valuable biotechnological solution for diseases surveillance.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140949986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Circulation of yellow fever virus in Benin city, Edo state Nigeria 尼日利亚埃多州贝宁市黄热病病毒的流行情况

IF 1.7 4区生物学

Biologicals Pub Date : 2024-04-08 DOI: 10.1016/j.biologicals.2024.101765

Joy Zitgwai Saidu , Nosakhare Odeh Eghafona

{"title":"Circulation of yellow fever virus in Benin city, Edo state Nigeria","authors":"Joy Zitgwai Saidu , Nosakhare Odeh Eghafona","doi":"10.1016/j.biologicals.2024.101765","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101765","url":null,"abstract":"<div><p>Yellow fever (YF) is one of the most acute viral hemorrhagic diseases of the 18th and 19th centuries, which continues to cause severe morbidity and mortality in Africa. After 21 years of no reported cases of yellow fever in Nigeria, till 2017 where a case was confirmed in Kwara State, also in November 2018,WHO was informed of a cluster of suspected yellow fever cases and deaths in Edo state, Nigeria. The study was among all age group attending health centres in Benin City, Edo state. A total of 280 blood samples were collected from consented febrile patients and were screened for antibodies to Zika virus using rapid diagnostic test (RDT) kits. Blood samples positive to Zika virus (IgM/IgG RDT), were subjected to molecular characterization. Using the <em>flavividae</em> family primers, six (6) samples where confirmed positive by Hemi-nested reverse transcription PCR (hnRT-PCR) sequencing. Nucleotide sequence blast revealed the sequenceswere similar to Yellow fever virus strains. Phylogenetic analysis revealed that the yellow fever virus sequences are closely related to the African strains. Despite the safe and effective yellow fever vaccine, yellow fever virus is seen to be in circulation, hence the need for continues mass vaccination.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140537206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model 将外膜囊泡作为纳米疫苗候选药物，在几内亚猪实验模型中抗击致病性钩端螺旋体

IF 1.7 4区生物学

Biologicals Pub Date : 2024-03-26 DOI: 10.1016/j.biologicals.2024.101764

S. David , Inbaraj Sophia , Subbaiyan Anbazhagan , M. Karikalan , R. Saravanan , K Nagaleekar Viswas , Prasad Thomas , Pallab Chaudhuri

{"title":"Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model","authors":"S. David , Inbaraj Sophia , Subbaiyan Anbazhagan , M. Karikalan , R. Saravanan , K Nagaleekar Viswas , Prasad Thomas , Pallab Chaudhuri","doi":"10.1016/j.biologicals.2024.101764","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101764","url":null,"abstract":"<div><p><em>Leptospira interrogans</em> serovar Hardjo is a long slender bacterium of size 0.1–0.3 μm × 5–50 μm. It is one of the major causes of bovine leptospirosis and is of economical importance because of the reproductive failure, still birth, abortion, and reduced productivity in cattle. It is also a zoonotic disease-causing infection in humans characterized by headaches, fever, chills, sweats and myalgia, lethargy, aching joints, pulmonary haemorrhages, and death in severe cases. Control of the disease involves antibiotic therapy, management and vaccination, of which immunization is the cheapest and effective means of disease prevention. The present study was developed to isolate and characterize the outer membrane vesicles of Leptospira interrogans serovar Hardjo and to evaluate their vaccine potential in guinea pig model. The OMVs were isolated from the culture by sonication and ultracentrifugation. In transmission electron microscopy, the isolated OMVs appeared as small spherical structures of 50–200 nm size. In Western blot and indirect ELISA, antibodies specific to OMVs were observed as indicative of a good humoral immune response elicited by L. interrogans serovar Hardjo OMV. The OMV-based Leptospira vaccine was able to prevent kidney lesions and renal colonization compared to the control and bacterin vaccinated group as proven by histopathology and PCR.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140295842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Standards for fecal microbiota transplant: Tools and therapeutic advances 粪便微生物群移植标准：工具和治疗进展

IF 1.7 4区生物学

Biologicals Pub Date : 2024-03-21 DOI: 10.1016/j.biologicals.2024.101758

Ilia Belotserkovsky , Lisa M. Stabryla , Monique Hunter , Jessica Allegretti , Benjamin J. Callahan , Paul E. Carlson , Phillip J. Daschner , Maryam Goudarzi , Cyril Guyard , Scott A. Jackson , Krishna Rao , Stephanie L. Servetas , Harry Sokol , Jennifer A. Wargo , Shawn Novick

{"title":"Standards for fecal microbiota transplant: Tools and therapeutic advances","authors":"Ilia Belotserkovsky , Lisa M. Stabryla , Monique Hunter , Jessica Allegretti , Benjamin J. Callahan , Paul E. Carlson , Phillip J. Daschner , Maryam Goudarzi , Cyril Guyard , Scott A. Jackson , Krishna Rao , Stephanie L. Servetas , Harry Sokol , Jennifer A. Wargo , Shawn Novick","doi":"10.1016/j.biologicals.2024.101758","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101758","url":null,"abstract":"<div><p>Fecal microbiota transplantation (FMT) has been demonstrated to be efficacious in preventing recurrent <em>Clostridioides difficile</em> (<em>C. difficile</em>) infections, and is being investigated for treatment of several other diseases including inflammatory bowel disease, cancer, obesity, liver disease, and diabetes. To speed up the translation of FMT into clinical practice as a safe and standardized therapeutic intervention, additional evidence-based technical and regulatory guidance is needed. To this end in May of 2022, the International Alliance for Biological Standardization (IABS) and the BIOASTER Microbiology Technology Institute hosted a second webinar to discuss key issues still impeding the advancement and standardization of FMT. The goal of this two-day webinar was to provide a forum for scientific experts to share and discuss data and key challenges with one another. Discussion included a focus on the evaluation of safety, efficacy, clinical trial design, reproducibility and accuracy in obtained microbiome measurements and data reporting, and the potential for standardization across these areas. It also focused on increasing the application potential and visibility of FMT beyond treating <em>C. difficile</em> infections.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140187143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

pH inactivation of SARS-CoV-2 and SARS-CoV in virus spiked protein A eluates from a mAb purification process 在 mAb 纯化过程中，通过 pH 值灭活加有病毒的蛋白 A 洗脱液中的 SARS-CoV-2 和 SARS-CoV

IF 1.7 4区生物学

Biologicals Pub Date : 2024-03-15 DOI: 10.1016/j.biologicals.2024.101753

Hannah Limburg , Marie Schwerdtner , Eileen Wilson , Bernhard Roth , Jean-Pol Cassart , Anke-Dorothee Werner , Anne Harbig , Eva Böttcher-Friebertshäuser , Anne Stokes

{"title":"pH inactivation of SARS-CoV-2 and SARS-CoV in virus spiked protein A eluates from a mAb purification process","authors":"Hannah Limburg , Marie Schwerdtner , Eileen Wilson , Bernhard Roth , Jean-Pol Cassart , Anke-Dorothee Werner , Anne Harbig , Eva Böttcher-Friebertshäuser , Anne Stokes","doi":"10.1016/j.biologicals.2024.101753","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101753","url":null,"abstract":"<div><p>Biopharmaceutical manufacturing processes may include a low pH treatment step as a means of inactivating enveloped viruses. Small scale virus clearance studies are routinely performed using model enveloped viruses such as murine leukemia virus to assess inactivation at the pH range used in the downstream manufacturing process. Further, as a means of bioburden reduction, chromatography resins may be cleaned and stored using sodium hydroxide and this can also inactivate viruses. The susceptibility of SARS-CoV-2 and SARS-CoV to low pH conditions using protein A eluate derived material from a monoclonal antibody production process as well as high pH cleaning conditions was addressed. SARS-CoV-2 was effectively inactivated at pH 3.0, moderately inactivated at pH 3.4, but not inactivated at pH 3.8. Low pH was less effective at inactivating SARS-CoV. Both viruses were inactivated at a high pH of ca.13.4. These studies provide important information regarding the effectiveness of viral clearance and inactivation steps of novel coronaviruses when compared to other enveloped viruses.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140134878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide 建立首个印度药典特立帕肽参考标准的合作研究报告

IF 1.7 4区生物学

Biologicals Pub Date : 2024-03-12 DOI: 10.1016/j.biologicals.2024.101755

Gaurav Pratap Singh Jadaun , M. Kalaivani , Mukesh Kumar , Gyanendra Nath Singh , Rajeev Singh Raghuvanshi , Parveen Jain , Participants of the Study

引用次数: 0

Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities 通过使用标准保持疫苗质量：当前的挑战和未来的机遇

IF 1.7 4区生物学

Biologicals Pub Date : 2024-03-12 DOI: 10.1016/j.biologicals.2024.101756

Nancy C. Sajjadi , Ryan Brady , Carmen Jungbäck , Laurent Mallet , Catherine Milne , Sandra Prior , Gayle Pulle , Peter Rigsby , Tim Schofield , Richard Siggers , Dean Smith , Paul Stickings , Sylvie Uhlrich , Wim Van Molle , Angela Walker , Tong Wu , Tiequn Zhou , Maria Baca-Estrada

{"title":"Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities","authors":"Nancy C. Sajjadi , Ryan Brady , Carmen Jungbäck , Laurent Mallet , Catherine Milne , Sandra Prior , Gayle Pulle , Peter Rigsby , Tim Schofield , Richard Siggers , Dean Smith , Paul Stickings , Sylvie Uhlrich , Wim Van Molle , Angela Walker , Tong Wu , Tiequn Zhou , Maria Baca-Estrada","doi":"10.1016/j.biologicals.2024.101756","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101756","url":null,"abstract":"<div><p>An international hybrid meeting held 21–22 June 2023 in Ottawa, Canada brought together regulators, scientists, and industry experts to discuss a set of principles and best practices in the development and implementation of standards. Although the use of international standards (ISs) and international units (IUs) has been an essential part of ensuring human and animal vaccine quality in the past decades, the types and uses of standards have expanded with technological advances in manufacture and testing of vaccines. The needs of stakeholders are evolving in response to the ever-increasing complexity, diversity, and number of vaccine products as well as increasing efforts to replace animal-based potency tests with <em>in vitro</em> assays that measure relevant quality attributes. As such, there must be a concomitant evolution in the design and implementation of both international and in-house standards. Concomitantly, greater harmonization of regulatory expectations must be achieved through collaboration with standard-setting organizations, national control laboratories and manufacturers. Stakeholders provided perspectives on challenges and several recommendations emerged as essential to advancing agreed upon objectives.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140104030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0