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Journals Biologicals : Journal of the I...

Biologicals : Journal of the International Association of Biological Standardization

https://read.qxmd.com/read/38763040/validation-of-a-next-generation-sequencing-method-for-adventitious-virus-detection-demonstration-of-sensitivity-in-multiple-cell-lines
#1
JOURNAL ARTICLE
Rebecca A Bova, Leyla Diaz, Scott Eubank, Amber Overgard, Alison Armstrong, Bradley Hasson
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...
May 18, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38759304/an-indirect-elisa-for-detecting-anti-sars-cov-2-antibodies-in-human-sera-using-a-baculovirus-expressed-recombinant-nucleocapsid-antigen
#2
JOURNAL ARTICLE
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
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...
May 16, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38749079/design-and-computational-evaluation-of-a-novel-multi-epitope-hybrid-vaccine-against-monkeypox-virus-potential-targets-and-immunogenicity-assessment-for-pandemic-preparedness
#3
JOURNAL ARTICLE
Allah Rakha Yaseen, Muhammad Suleman, Aqsa Jabeen, Laiba Nezami, Abdul Salam Qadri, Ayesha Arif, Iram Arshad, Khadija Iqbal, Tasuduq Yaqoob, Zoha Khan
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...
May 14, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38733709/overview-of-regulatory-frameworks-on-the-national-lot-release-of-plasma-derived-medicinal-products-in-korea
#4
JOURNAL ARTICLE
Su Kyoung Seong, Young Hoon Kim, Youngju Choi, Hyun Jung Koh, Seong Jae Kim, Myoung Jun Kim, Chan Woong Choi
Plasma-derived medicinal products (PDMPs) are essential in the treatment of acute and chronic life-threatening diseases. The Korea Ministry of Food and Drug Safety has conducted a national lot release (NLR) of PDMPs since 2012 based on a summary protocol review system and lot release testing. However, few studies have investigated the performance or characteristics of the NLR framework. Over the past decade, the NLR of PDMPs was approximately 1000 per year, including mainly albumins, immunoglobulins, fibrin sealant kits, and coagulation factors, among others...
May 10, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38704951/comparison-of-skeletal-muscle-decellularization-protocols-and-recellularization-with-adipose-derived-stem-cells-for-tissue-engineering
#5
JOURNAL ARTICLE
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
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)...
May 4, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38703474/from-eradication-to-re-emergence-the-changing-landscape-of-polio-in-the-cvdpv2-era
#6
LETTER
Muhammad Tahir Hayat, Mariam Badam, Javaria Qazi
No abstract text is available yet for this article.
May 3, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38641502/prevalence-of-viral-agents-causing-swine-reproductive-failure-in-korea-and-the-development-of-multiplex-real-time-pcr-and-rt-pcr-assays
#7
JOURNAL ARTICLE
Go-Eun Shin, Kyoung-Ki Lee, Bok-Kyung Ku, Su Hong Oh, Sang-Ho Jang, Bokyu Kang, Hye-Young Jeoung
This study aimed to investigate the prevalence of viral agents causing reproductive failure in pigs in Korea. In addition, two types of multiplex real-time PCR (mqPCR) were developed for the simultaneous detection of Aujeszky's disease virus (ADV) and porcine parvovirus (PPV) in mqPCR and encephalomyocarditis virus (EMCV) and Japanese encephalitis virus (JEV) in reverse transcription mqPCR (mRT-qPCR). A total of 150 aborted fetus samples collected from 2020 to 2022 were analyzed. Porcine reproductive and respiratory syndrome virus was the most prevalent (49/150 32...
April 18, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38593685/circulation-of-yellow-fever-virus-in-benin-city-edo-state-nigeria
#8
JOURNAL ARTICLE
Joy Zitgwai Saidu, Nosakhare Odeh Eghafona
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...
April 8, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38537360/outer-membrane-vesicles-as-nanovaccine-candidates-against-pathogenic-leptospira-in-experimental-guinea-pig-model
#9
JOURNAL ARTICLE
S David, Inbaraj Sophia, Subbaiyan Anbazhagan, M Karikalan, R Saravanan, K Nagaleekar Viswas, Prasad Thomas, Pallab Chaudhuri
Leptospira interrogans 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...
March 26, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38518435/standards-for-fecal-microbiota-transplant-tools-and-therapeutic-advances
#10
JOURNAL ARTICLE
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
Fecal microbiota transplantation (FMT) has been demonstrated to be efficacious in preventing recurrent Clostridioides difficile (C. difficile) 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...
March 21, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38492418/ph-inactivation-of-sars-cov-2-and-sars-cov-in-virus-spiked-protein-a-eluates-from-a-mab-purification-process
#11
JOURNAL ARTICLE
Hannah Limburg, Marie Schwerdtner, Eileen Wilson, Bernhard Roth, Jean-Pol Cassart, Anke-Dorothee Werner, Anne Harbig, Eva Böttcher-Friebertshäuser, Anne Stokes
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...
March 14, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38479213/maintaining-the-quality-of-vaccines-through-the-use-of-standards-current-challenges-and-future-opportunities
#12
JOURNAL ARTICLE
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
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...
March 12, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38479212/report-of-a-collaborative-study-to-establish-the-first-indian-pharmacopoeia-reference-standard-for-teriparatide
#13
JOURNAL ARTICLE
Gaurav Pratap Singh Jadaun, M Kalaivani, Mukesh Kumar, Gyanendra Nath Singh, Rajeev Singh Raghuvanshi, Parveen Jain
A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph...
March 12, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38428357/report-for-the-eighth-asian-national-control-laboratory-network-meeting-in-2023-self-sufficiency-strategy-of-plasma-derived-medicinal-products-and-regulatory-harmonisation
#14
JOURNAL ARTICLE
Chan Woong Choi, Youngju Choi, Yuyun Siti Maryuningsih, Bayu Wibisono, Jong Won Kim, Dio Ramondrana, Takuo Mizukami, Masaki Ochiai, Azraini Abdul Samat, Caren Mangorangca, Dung Luu Thi, Hung Pham Van, Sun Bo Shim, Su Kyoung Seong, In Soo Shin
The Eighth Asian National Control Laboratory (NCL) Network meeting, entitled "Biological Products Quality Control and Self-Sufficiency Strategy focusing on plasma-derived medicinal products (PDMPs)" was held in Seoul on 31 August 2023. The participants were NCL experts from Indonesia, Japan, Malaysia, the Philippines, Vietnam, and the Republic of Korea. Special lectures included the PDMPs self-sufficiency strategies of the World Health Organization (WHO) and Indonesian Food and Drug Authority, and a case study on Global Benchmarking Tool (GBT) assessment for vaccines by the Korea Ministry of Food and Drug Safety...
February 29, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38402730/the-current-status-of-the-biosimilars-landscape-in-china
#15
REVIEW
Gangling Xu, Junzhi Wang
Biosimilars have played a significant role in alleviating healthcare burdens and enhancing patient access to high-quality biologic-based pharmaceutical therapies. The World Health Organization (WHO), as well as various national governments and regulatory agencies, have established corresponding regulations and guidelines to encourage the development of biosimilars. China, as a populous nation with a substantial demand for biologic therapies, has made substantial investments in the research and development (R&D) of a number of biosimilars, making it the global leader in terms of the number of biosimilar varieties developed and the companies involved...
February 24, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38401400/development-of-an-elisa-for-the-detection-of-fowl-adenovirus-serotype-4-utilizing-fiber-protein
#16
JOURNAL ARTICLE
Faiza Ather, Muhammad Ashir Zia, Mudasser Habib, Muhammad Salah-Ud-Din Shah
Hydropericardium syndrome (HPS), caused by the Fowl adenovirus 4 (FAdV-4) has led to significant financial losses for the poultry industry globally, including Pakistan over the past few years. Conventional serological methods are time consuming, laborious and less sensitive therefore, a rapid and sensitive ELISA kit is required for the reliable detection of FAdV-4 infection. In the current research, fiber proteins (1 &2) of FAdV-4 were successfully expressed in Escherichia coli and purified using metal affinity chromatography...
February 23, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38387156/viral-clearance-capability-of-monoclonal-antibody-purification
#17
JOURNAL ARTICLE
Kang Cai, Jennifer Anderson, Etienne Utiger, Gisela Ferreira
Viral clearance steps are routinely included in monoclonal antibody purification processes to safeguard product from potential virus contamination. These steps are often experimentally studied using product-specific feeds and parameters for each project to demonstrate viral clearance capability. However, published evidence suggests that viral clearance capability of many of these steps are not significantly impacted by variations in feed material or process parameter within commonly used ranges. The current investigation confirms robust retrovirus inactivation by low pH treatment and parvovirus removal by second-generation virus filters, independent to individual antibody molecules...
February 21, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38360428/the-role-of-real-world-evidence-for-regulatory-and-public-health-decision-making-for-accelerated-vaccine-deployment-a-meeting-report
#18
JOURNAL ARTICLE
Kaatje Bollaerts, Chloé Wyndham-Thomas, Elizabeth Miller, Hector S Izurieta, Steve Black, Nick Andrews, Michelle Rubbrecht, Fran Van Heuverswyn, Pieter Neels
The COVID-19 pandemic underscored the need for rapid evidence generation to inform public health decisions beyond the limitations of conventional clinical trials. This report summarises presentations and discussions from a conference on the role of Real-World Evidence (RWE) in expediting vaccine deployment. Attended by regulatory bodies, public health entities, and industry experts, the gathering was a collaborative exchange of experiences and recommendations for leveraging RWE for vaccine deployment. RWE proved instrumental in refining decision-making processes to optimise dosing regimens, enhance guidance on target populations, and steer vaccination strategies against emerging variants...
February 14, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38350825/fourth-controlled-human-infection-model-chim-meeting-chims-in-endemic-countries-may-22-23-2023
#19
JOURNAL ARTICLE
Melissa Kapulu, Lucinda Manda-Taylor, Shobana Balasingam, Gary Means, Mikal Ayiro Malungu, Philip Bejon, Primus Che Chi, Christopher Chiu, E Chandler Church, Rodrigo Correa-Oliveira, Nicholas Day, Anna Durbin, Moses Egesa, Claudia Emerson, Kondwani Jambo, Roli Mathur, Wolfram Metzger, Noni Mumba, Winfred Nazziwa, Ally Olotu, Jacqueline Rodgers, Frank Sinyiza, Kawsar Talaat, Ingrid Kamerling, Charlie Weller, Marc Baay, Pieter Neels
Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used...
February 12, 2024: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/38350349/ethical-approval-for-controlled-human-infectious-model-clinical-trial-protocols-a-workshop-report
#20
JOURNAL ARTICLE
Euzebiusz Jamrozik, Katherine Littler, Irina Meln, Wim Van Molle, Sandra Morel, Ole F Olesen, Michelle Rubbrecht, Shobana Balasingam, Pieter Neels
Controlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop "Ethical Approval for CHIM Clinical Trial Protocols", which took place on May 30-31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteria for CHIM and the role(s) of CHIM in pharmaceutical development...
February 12, 2024: Biologicals: Journal of the International Association of Biological Standardization
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