-
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities Biologicals (IF 1.7) Pub Date : 2024-03-12 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
-
Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide Biologicals (IF 1.7) Pub Date : 2024-03-12 Gaurav Pratap Singh Jadaun, M. Kalaivani, Mukesh Kumar, Gyanendra Nath Singh, Rajeev Singh Raghuvanshi, Parveen Jain, Participants of the Study
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
-
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation Biologicals (IF 1.7) Pub Date : 2024-03-01 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
-
The current status of the biosimilars landscape in China Biologicals (IF 1.7) Pub Date : 2024-02-24 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
-
Development of an ELISA for the detection of fowl adenovirus serotype −4 utilizing fiber protein Biologicals (IF 1.7) Pub Date : 2024-02-23 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
-
Viral clearance capability of monoclonal antibody purification Biologicals (IF 1.7) Pub Date : 2024-02-21 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
-
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report Biologicals (IF 1.7) Pub Date : 2024-02-15 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
-
Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023 Biologicals (IF 1.7) Pub Date : 2024-02-13 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
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
-
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report Biologicals (IF 1.7) Pub Date : 2024-02-12 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
-
Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023 Biologicals (IF 1.7) Pub Date : 2024-02-10 Marco Cavaleri, David Kaslow, Eric Boateng, Wilbur H. Chen, Christopher Chiu, Robert K.M. Choy, Rodrigo Correa-Oliveira, Anna Durbin, Moses Egesa, Malick Gibani, Melissa Kapulu, Melba Katindi, Ally Olotu, Pongphaya Pongsuwan, Michelo Simuyandi, Bruno Speder, Kawsar R. Talaat, Charlie Weller, Bridget Wills, Marc Baay, Shobana Balasingam, Ole F. Olesen, Pieter Neels
Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, 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
-
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency Biologicals (IF 1.7) Pub Date : 2024-02-09 Reihaneh Mirhassani, Ehsan Seyedjafari, Behrouz Vaziri
Vaccine potency is typically evaluated using an assay that acts as a surrogate for biological activity. Although in vivo vaccines better represent human immunological responses, in vitro assays are preferred due to lower variability, higher throughput, easier validation and ethical considerations. In in vitro determination of Human Papillomavirus (HPV), Virus-like particle (VLP) vaccine potency currently
-
Molecular characterization of Anaplasma ovis Msp4 protein in strains isolated from ticks in Turkey: A multi-epitope synthetic vaccine antigen design against Anaplasma ovis using immunoinformatic tools Biologicals (IF 1.7) Pub Date : 2024-02-06 Ahmet Efe Köseoğlu, Hüseyin Can, Mervenur Güvendi, Sedef Erkunt Alak, Aysu Değirmenci Döşkaya, Muhammet Karakavuk, Mert Döşkaya, Cemal Ün
Tick-borne pathogens increasingly threaten animal and human health as well as cause great economic loss in the livestock industry. Among these pathogens, causing a decrease in meat and milk yield is frequently detected in sheep in many countries including Turkey. This study aimed to reveal potential vaccine candidate epitopes in Msp4 protein using sequence data from isolates and then to design a multi-epitope
-
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report Biologicals (IF 1.7) Pub Date : 2024-02-03 Nicoletta Corti, Christopher Chiu, Rebecca J. Cox, Clarisse Demont, Jeanne-Marie Devaster, Othmar G. Engelhardt, Andrew Gorringe, Khaole Hassan, Marcel Hoefnagel, Ingrid Kamerling, Oleg Krut, Chelsea Lane, Reinhard Liebers, Catherine Luke, Wim Van Molle, Sandra Morel, Pieter Neels, Meta Roestenberg, Michelle Rubbrecht, Wiep Klaas Smits, Daniel Stoughton, Kawsar Talaat, Maria J.G.T. Vehreschild, Adrian
Within the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 technical white paper “Considerations on the Principles
-
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology Biologicals (IF 1.7) Pub Date : 2024-01-12 Gloria Paulina Monterrubio-López, José Luis Llamas-Monroy, Ángel Antonio Martínez-Gómez, Karen Delgadillo-Gutiérrez
Whooping cough is a disease caused by Bordetella pertussis, whose morbidity has increased, motivating the improvement of current vaccines. Reverse vaccinology is a strategy that helps identify proteins with good characteristics fast and with fewer resources. In this work, we applied reverse vaccinology to study the B. pertussis proteome and pangenome with several in-silico tools. We analyzed the B
-
Efficient extraction of adventitious virus nucleic acid using commercially available methods Biologicals (IF 1.7) Pub Date : 2023-12-28 William G. Valiant, Jon Borman, Kang Cai, Peter M. Vallone
An essential step in pharmaceutical product development is screening for contamination with adventitious agents, and there is desire to develop highly sensitive assays to detect adventitious viral nucleic acid. This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious
-
Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products Biologicals (IF 1.7) Pub Date : 2023-12-15 Takamasa Hirai, Kiyoko Kataoka, Yuzhe Yuan, Keisuke Yusa, Yoji Sato, Kazuhisa Uchida, Ken Kono
Next-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft indicates that NGS could be an alternative or supplement to in vitro viral tests. To examine the performance of NGS for the in vitro detection of viruses
-
An antibody-free evaluation of an mRNA COVID-19 vaccine Biologicals (IF 1.7) Pub Date : 2023-12-14 Paul J. Branham, Hans C. Cooper, Yulanda M. Williamson, Fabio N. Najjar, William J.H. Sutton, Carrie L. Pierce-Ruiz, John R. Barr, Tracie L. Williams
This manuscript describes the use of an analytical assay that combines transfection of mammalian cells and isotope dilution mass spectrometry (IDMS) for accurate quantification of antigen expression. Expired mRNA COVID-19 vaccine material was stored at 4 °C, room temperature (∼25 °C), and 56 °C over a period of 5 weeks. The same vaccine was also exposed to 5 freeze-thaw cycles. Every week, the spike
-
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice Biologicals (IF 1.7) Pub Date : 2023-12-14 Karrar Ali Mohammed Hasan Alsakini, Furkan Ozan Çöven, Ayse Nalbantsoy
Vaccines have long made use of adjuvants to boost the immune response of the body and reduce the amount of vaccine needed as well as the expense of producing the vaccine. Many vaccine adjuvants are in development, but their application in veterinary vaccinations is restricted due to their lack of efficacy or undesirable side effects. For this reason, it is essential to develop novel adjuvants. To address
-
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis Biologicals (IF 1.7) Pub Date : 2023-12-14 Cecilia Silvarrey, Gabriela Alvite, Adriana Esteves
Cystic Echinococcosis is a cosmopolitan zoonosis closely linked to poverty and ignorance. It affects both cattle and humans, causing significant losses to both human and animal health. To date, there is no effective way to combat this. Our proposal focused on the formulation of poly (lactic-co-glycolic acid (PLGA) and Eudragit-RSPO polymeric nanoparticles, which are suitable to encapsulate an antigen
-
Fifty years of advancing biologicals and beyond Biologicals (IF 1.7) Pub Date : 2023-11-21 Rajesh Gupta, Griffiths Elwyn, Girish Vyas, Robin Thorpe, Norman Baylor
Abstract not available
-
Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections Biologicals (IF 1.7) Pub Date : 2023-11-16 Mohammed El-Mowafy, Mohamed El-Mesery, Mahmoud A.F. Khalil, Ahmed El-Mesery, Abdelaziz Elgaml
Hepatitis B virus (HBV) is responsible for most of the viral hepatitis worldwide. HBV is a partially double stranded DNA virus that is composed of four main open reading frames (ORFs) encoding its important antigens, namely hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBcAg), HBV polymerase and hepatitis B X antigen (HBxAg). In this study, we report a successful method for the cloning
-
Enabling the evaluation of COVID-19 vaccines with correlates of protection Biologicals (IF 1.7) Pub Date : 2023-11-16 Arnaud Marchant, Pierre Van Damme, Stanley Plotkin, Pieter Neels, Maria Cristina Cassetti, Jakob Cramer, Marion F. Gruber, David Goldblatt, Deborah King, Wendy Hartig-Merkel, Joris Vandeputte
In February 2023, a meeting about correlates of protection (CoPs) against COVID-19 was organized by the International Alliance for Biological Standardization, the European Plotkin Institute for Vaccinology, and Vaccinopolis. The meeting aimed at reviewing the evidence, drawing conclusions, and identifying knowledge gaps. Collection of evidence is not straightforward. Neutralizing antibodies correlate
-
Evaluating the sensitivity of newborn rats and newborn hamsters to oncogenic DNA. Biologicals (IF 1.7) Pub Date : 2023-11-16 Li Sheng-Fowler,Wei Tu,Kathryn Phy,Juliete Macauley,Lynda Lanning,Andrew M Lewis,Keith Peden
To evaluate the risk of residual cellular DNA in vaccines manufactured in tumorigenic cell lines, we have been establishing in vivo assays to quantify the oncogenic activity of DNA. We had generated three oncogene-expression plasmids: pMSV-T24-H-ras, which expresses activated H-ras; pMSV-c-myc, which expresses c-myc; and pMSV-T24-H-ras/MSV-c-myc, which expresses both oncogenes. Tumors were induced
-
A rapid and simple sterility test method based on solid culture medium containing blood Biologicals (IF 1.7) Pub Date : 2023-11-11 Neetu Raghav, Seema Parveen, Simleen Kaur, Selwyn A. Wilson David, Hyesuk Kong, James L. Kenney, Rajesh K. Gupta
Current sterility test performed for most biological products takes 14 days. We evaluated solid medium, containing 5% blood for use in the membrane filtration (MF) and direct inoculation (DI) sterility test. Representative microorganisms prepared in a sample matrix at approximately 0.1, 1, 10 and 100 colony forming units were tested for growth by compendial MF sterility test using fluid thioglycolate
-
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics Biologicals (IF 1.7) Pub Date : 2023-11-09 Loushambam Samananda Singh
Antibiotic resistance has become the major concern for global public health. Phage therapy is being considered as an alternative for antibiotics to treat the multidrug resistant bacterial infections. Bacteriophage therapeutic developments has faced many challenges, including the drug formulations for sustainable phage delivery. The nano-emulsion platform has been described as the best approach to retain
-
Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India. Biologicals (IF 1.7) Pub Date : 2023-11-07 Sushmita Nautiyal,Sukdeb Nandi,Kirtika Sharma,Vivek Gairola,K G Sai Balaji,Sanchay Kumar Biswas,Ravikant Agrawal,Sonalika Mahajan,Karam Pal Singh,Gaurav Kumar Sharma
Bovine herpes virus-1 (BoHV-1) is responsible for production losses through decreased milk yields, abortions, infertility, and trade restrictions in the bovine population. The disease is endemic in many countries including India. As the virus harbors a unique feature of latency animals once infected with the virus remain sero-positive for lifetime and can re-excrete the virus when exposed to stressful
-
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities Biologicals (IF 1.7) Pub Date : 2023-11-01 Elliot Lilley, Martijn Bruysters, Pradip Das, Simeon Gill, Richard Isbrucker, David Jones, Anthony Holmes
The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) is reviewing World Health Organization (WHO) manuals, guidelines and recommendations for vaccines and biotherapeutics to identify the extent to which animal-based testing methods are described. The aim is to recommend where updates to these documents can lead to an increased and more harmonised adoption
-
Corrigendum to “Comparison of Astra Zeneca and sinopharm vaccines as boosters in protection against COVID-19 infection” [Biologicals 82 (2023) 101668] Biologicals (IF 1.7) Pub Date : 2023-10-20 Arash Letafati, Nooshin Eyvazzadeh, Amirhossein Gharehkhani, Ayeh Khorshidian, Siavash Chalabiani, Elnaz Khodadoust Soufiani, Niloofar Khakpoor, Benyamin Shamsodini, Taranom Beheshti, Raha Taheri Bavili Olyaei, Anahita Soleimani, Fatemeh Melyani, Ghazal Mashhadi Hossein
Abstract not available
-
Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure Biologicals (IF 1.7) Pub Date : 2023-10-12 Na Liu, Tiandan Xu
Virus filtration is a robust and effective method to remove potential virus contaminants. Planova 20 N, a virus filter form Asahi Kasei Bioprocess, has been widely used in the manufacturing process of biotherapeutics. Previous studies have shown that parvovirus removal by Planova 20 N can be impacted by low operation pressure and depressurization. Therefore, it is critical to define an operating pressure
-
Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh Biologicals (IF 1.7) Pub Date : 2023-10-05 Barna Goswami, Md Murshed Hasan Sarkar, Shahina Akter, Tanjina Akhtar Banu, Iffat Jahan, Md Saddam Hossain, Mohammad Mohi Uddin, Tasnim Nafisa, Md Maruf Ahmed Molla, Mahmuda Yeasmin, Eshrar Osman, Mohammad Samir Uzzaman, Abu Sayeed Mohammad Mahmud, Ahashan Habib, Salim Khan
In the present study, we report the complete genome of five Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) from Bangladesh harboring mutations at Spike protein (E484K, Q677H, D614G, A67V, Q52R, Y144del, H69del, V70del, F888L) assigned to the B.1.525 lineage (Variant of interest). Mutations are also found in viral structural proteins other than spike region (E_L21F, M_I82F, N_A12G and
-
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2 Biologicals (IF 1.7) Pub Date : 2023-10-04 Navid Momenifar, Mohammad Pirouzfar, Zohreh Hashemian, Abdolreza Daneshvar Amoli
SARS-COV-2 is the causative agent of an acute respiratory syndrome called Coronavirus disease 2019 (COVID-19) with a varying mortality rate from 2019 to 2022. There are several measures for control and prevention of Covid-19 including using mask, vaccine injections, as well as screening the potential cases. We aimed to design and develop a molecular method (RT-LAMP) for detecting coronavirus in biological
-
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states Biologicals (IF 1.7) Pub Date : 2023-10-03 Sun Bo Shim, Chan Woong Choi, Jin Ho Shin, Jong Won Kim, Silke Schepelmann, Jae Ho Jung, Harish Chander, Ratih Pujilestari, Madoka Kuramitsu, Masaki Ochiai, Nee Yuan Qi, Geraldine N. Dimapilis, Luu Thi Dung, Hyung Sil Moon, In Soo Shin
The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference
-
Development and evaluation of an external quality control and internal quality control containing real-time RT-PCR assay for the detection of o'nyong-nyong virus Biologicals (IF 1.7) Pub Date : 2023-10-04 Hai-Bo Wang, Tian Du, Ji-Hong Lin, Xin-Bin Chen, Cheng-Ning Tu
O'nyong-nyong fever is a mosquito-borne tropical viral disease while few molecular diagnostic tools have been established for its surveillance until now. In the current study, a single-step, dual-color real-time reverse transcription polymerase chain reaction (RT-PCR) assay which contained both external quality control (EQC) and internal quality control (IQC) prepared by armored RNA technique was developed
-
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing Biologicals (IF 1.7) Pub Date : 2023-10-02 Takao ITO, Hui Wang, Soon-Hwa Hwang, Bin Wang, Lizhi Wang, Somasundaram G
In the current transition to intensified upstream processing, the risks of adopting traditional single-use systems for high-titer, long-duration perfusion cultures, have thus far not been considered. This case study uses the Failure Modes and Effects Analysis (FMEA) method to evaluate the risks associated with implementing upstream single-use technology. The simulated model process was used to compare
-
In silico discovery of epitopes of gag and env proteins for the development of a multi-epitope vaccine candidate against Maedi Visna Virus using reverse vaccinology approach Biologicals (IF 1.7) Pub Date : 2023-10-02 Ecem Su Koçkaya, Hüseyin Can, Yalçın Yaman, Cemal Ün
Maedi Visna Virus (MVV) causes a chronic viral disease in sheep. Since there is no specific therapeutic drug that targets MVV, development of a vaccine against the MVV is inevitable. This study aimed to analyze the gag and env proteins as vaccine candidate proteins and to identify epitopes in these proteins. In addition, it was aimed to construct a multi-epitope vaccine candidate. According to the
-
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab Biologicals (IF 1.7) Pub Date : 2023-09-23 Mayra G. Quiñonez-Alvarado, Paulina Chávez-Hurtado, Jesús C. Caro-Palomera, Oriana L. Niño-Trejo, José I. Jiménez-Dolores, Patricia Muñoz-Villegas, Leopoldo Baiza-Durán, Juan D. Quintana-Hau
PRO-169 is an anti-VEGF monoclonal antibody developed by Laboratorios Sophia that shares its sequence with Bevacizumab (BVZ); though, PRO-169 is intended for intravitreal administration. In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further
-
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China Biologicals (IF 1.7) Pub Date : 2023-09-12 Jiaqi Lu, Wei Wei, Wu He
In recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality
-
Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test Biologicals (IF 1.7) Pub Date : 2023-08-30 Rob Tierney, Jason Hockley, Shalini Rajagopal, Paul Stickings
Here we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule
-
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report Biologicals (IF 1.7) Pub Date : 2023-08-27 Gwenaël Cirefice, Katrin Schütte, Ingo Spreitzer, Emmanuelle Charton, Shahjahan Shaid, Laura Viviani, Michelle Rubbrecht, Irene Manou
The rabbit pyrogen test (RPT) was the benchmark for pyrogenicity testing, but scientific advancements have provided innovative and humane methods, such as the in vitro monocyte-activation test (MAT). However, transitioning from the RPT to the MAT has been challenging. The European Directorate for the Quality of Medicines & HealthCare, the Council of Europe, and the European Partnership for Alternative
-
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells Biologicals (IF 1.7) Pub Date : 2023-08-14 Zhenbin Liu, Mengyuan Pei, Geng Liu, Zhenyu Qiu, Siya Wang, Zilin Qiao, Jiamin Wang, Dongwu Jin, Jiayou Zhang, Kai Duan, Xuanxuan Nian, Zhongren Ma, Xiaoming Yang
MDCK is currently the main cell line used for influenza vaccine production in culture. Previous studies have reported that MDCK cells possess tumorigenic ability in nude mice. Although complete cell lysis can be ensured during vaccine production, host cell DNA released after cell lysis may still pose a risk for tumorigenesis. Greater caution is needed in the production of human vaccines; therefore
-
Tumorigenesis mechanism and application strategy of the MDCK cell line: A systematic review Biologicals (IF 1.7) Pub Date : 2023-08-11 Di Yang, Lingwei Huang, Jiamin Wang, Huihao Wu, Zhenbin Liu, Ayimuguli Abudureyimu, Zilin Qiao
Influenza is an acute respiratory infectious disease caused by influenza virus that seriously endangers people's health. Influenza vaccination is the most effective means to prevent influenza virus infection and its serious complications. MDCK cells are considered to be superior to chicken embryos for the production of influenza vaccines, but the tumorigenicity of cells is a concern over the theoretical
-
Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim Biologicals (IF 1.7) Pub Date : 2023-08-08 Sunil Gairola, Prashant Bonde, Pankaj Sharma, Sameer kale, Sunil Goel, Suresh Jadhav
Meningococcal A Conjugate Vaccine (MenAfriVac) is the world’s first Monovalent Conjugate Vaccine against Neisseria Meningitidis serogroup A which has obtained Controlled Temperature Chain (CTC) label claim of “stable upto 40°C for 4 days prior to reconstitution” developed by Serum Institute of India Pvt. Ltd. Pune, India and the vaccine was granted permission from World health Organization. This paper
-
3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report Biologicals (IF 1.7) Pub Date : 2023-07-27 Laura Viviani, Elisabeth Balks, Sonja Beken, Anna-Maria Brady, Rick Clayton, Florence Cliquet, Liys Desmayanti, Silvia Fragoeiro, Terrie Jo Hamtak, David John, Carmen Jungbaëck, M. Kalaivani, Imke Kross, Catherine Lang, Ni Made Ria Isriyanthi, Laurent Mallet, Catherine Milne, Michelle Rubbrecht, Botond Siklódi, Brajesh Singh, Joris Vandeputte
Regulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies
-
On-column virus inactivation by solvent/detergent treatment for a recombinant biological product Biologicals (IF 1.7) Pub Date : 2023-07-28 Daniel Polasek, Andreas Flicker, Christian Fiedler, Maria R. Farcet, Martin Purtscher, Thomas R. Kreil
Each process step in the manufacture of biological products requires expensive resources and reduces total process productivity. Since downstream processing of biologicals is the main cost driver, process intensification is a persistent topic during the entire product life cycle. We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent
-
Epidemiology-driven approaches to surveillance in HPAI-vaccinated poultry flocks aiming to demonstrate freedom from circulating HPAIV Biologicals (IF 1.7) Pub Date : 2023-07-24 Timm Harder, Sjaak de Wit, Jose L. Gonzales, Jeremy H.P. Ho, Paolo Mulatti, Teguh Y. Prajitno, Arjan Stegeman
Incursion pressure of high pathogenicity avian influenza viruses (HPAIV) by secondary spread among poultry holdings and/or from infected migratory wild bird populations increases worldwide. Vaccination as an additional layer of protection of poultry holdings using appropriately matched vaccines aims at reducing clinical sequelae of HPAIV infection, disrupting HPAIV transmission, curtailing economic
-
Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals Biologicals (IF 1.7) Pub Date : 2023-07-19
Next-generation sequencing (NGS) has been proven to address some of the limitations of the current testing methods for adventitious virus detection in biologics. The International Alliance for Biological Standardization (IABS), the U.S. Food and Drug Administration (FDA), and the European Directorate for the Quality of Medicines and Healthcare (EDQM) co-organized the “3rd Conference on Next-generation
-
Enhanced productivity and stability of PRV in recombinant ST-Tret1 cells Biologicals (IF 1.7) Pub Date : 2023-07-11
Productivity and stability of Pseudorabies virus (PRV) are critical for the manufacture and storage of live attenuated pseudorabies vaccine. Trehalose is commonly used as a cryoprotectant to stabilize organisms during freezing and lyophilization. Trehalose transporter 1 (Tret1), derived from Polypedilum vanderplanki, can deliver trehalose with a reversible transporting direction. In this study, we
-
Confirming the absence of parental African swine fever virus as a potential contaminant of recombinant live attenuated ASF vaccines Biologicals (IF 1.7) Pub Date : 2023-06-03 Lauro Velazquez-Salinas, Elizabeth Ramirez-Medina, Ayushi Rai, Sarah Pruitt, Elizabeth A. Vuono, Nallely Espinoza, Cyril G. Gay, Steve Witte, Douglas P. Gladue, Manuel V. Borca
African swine fever (ASF) is a devastating disease that is currently producing a panzootic significantly impacting the swine industry worldwide. One of the major challenges for advancing the development of ASF vaccines has been the absence of international standards for ASF vaccine purity, potency, safety, and efficacy. To date, the most effective experimental vaccines have been live attenuated strains
-
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report Biologicals (IF 1.7) Pub Date : 2023-05-25 Brinda Poojary, Laura Viviani, Alokparna Sengupta, M. Kalaivani, Sh Rajesh Verma, Vijay Teng, Vijay Makhija, Ram Prakash, Nitin Bhatia, S.N. Singh, Lukas Bruckner, Marlies Halder, Jeroen Vree
Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives
-
Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow Biologicals (IF 1.7) Pub Date : 2023-05-16 Sebastian Miles, Sylvia Dematteis, Gustavo Mourglia-Ettlin
Vaccines are among the most important advances in medicine throughout the human history. However, conventional vaccines exhibit several drawbacks in terms of design and production costs. Peptide-based vaccines are attractive alternatives, since they can be designed mainly in silico, can be produced cheaply and safely, and are able to induce immune responses exclusively towards protective epitopes.
-
Development of a droplet digital PCR for pertussis toxin locus copy number determination in a genetically-modified Bordetella pertussis strain Biologicals (IF 1.7) Pub Date : 2023-05-05 Raphaël Esson, Stéphanie Falque, Eric Abachin, Steve George, Nolwenn Nougarede
To improve pertussis toxin (PT) yield in B. pertussis strains for vaccine production a genetically-engineered strain (gdPT 191-134 strain) with a second copy of the genetically detoxified PT (gdPT) locus was developed. The consistency of the production and genetic stability of the strain when used for vaccine production must be established. We developed two simplex ddPCR assays with PCR systems for
-
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine Biologicals (IF 1.7) Pub Date : 2023-05-05 Laura Hassall, Peter Rigsby, Paul Stickings
The International Standard for Diphtheria Antitoxin Equine is essential for the standardisation of assays used to determine the potency of therapeutic diphtheria antitoxin products produced from equine serum. This paper describes the production and characterization of the 2nd International Standard for Diphtheria Antitoxin Equine and its calibration in International Units. Calibration was performed
-
A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea Biologicals (IF 1.7) Pub Date : 2023-05-03 Chan Woong Choi, Su Kyoung Seong, Ki Won Han, Hyun Jeong Kim, Kyung Hee Sohn, Sun Bo Shim, Yun Su Bang, JungHwan Cho, In Soo Shin
This study aimed to establish a second national standard for hepatitis B immunoglobulin (HBIG) that can be used for potency assays of hepatitis B and normal immunoglobulin. The candidate material was manufactured using a process approved as Good Manufacturing Practice. The freeze-dried candidate preparation was tested for physicochemical and biological properties, including pH, residual moisture, molecular
-
Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing Biologicals (IF 1.7) Pub Date : 2023-05-03 Megan H. Cleveland, Erica L. Romsos, Carolyn R. Steffen, Nathan D. Olson, Stephanie L. Servetas, William G. Valiant, Peter M. Vallone
In response to the COVID-19 pandemic, the National Institute of Standards and Technology released a synthetic RNA material for SARS-CoV-2 in June 2020. The goal was to rapidly produce a material to support molecular diagnostic testing applications. This material, referred to as Research Grade Test Material 10169, was shipped free of charge to laboratories across the globe to provide a non-hazardous
-
An ELISA system for tetanus toxoid potency tests: An alternative to lethal challenge Biologicals (IF 1.7) Pub Date : 2023-04-30 Masaaki Iwaki, Tsuyoshi Kenri, Mitsutoshi Senoh
For a long time, a widely used method for tetanus toxoid (Ttd) potency has been the challenge test, in which animals are immunized and then challenged with tetanus toxin in lethal or non-lethal way. In the context of animal welfare, an alternative is desired because the method causes unsustainable distress to animals. We aimed to replace the system for describing test results, in which scores are assigned
-
Klebsiella pneumoniae vaccine studies in animal models Biologicals (IF 1.7) Pub Date : 2023-04-29 Parivash Ranjbarian, Zahra Sobhi Amjad, Roya Chegene Lorestani, Ali Shojaeian, Mosayeb Rostamian
The treatment of Klebsiella pneumoniae is faced with challenges demanding the development of a vaccination strategy. However, no approved and globally available vaccine exists yet. This study aimed to systematically review all published data on K. pneumoniae vaccines in animal models. Without time restrictions, electronic databases were searched using appropriate keywords. The retrieved studies were
-
Dose-sparing effect of Sabin-derived inactivated polio vaccine produced in Japan by intradermal injection device for rats Biologicals (IF 1.7) Pub Date : 2023-04-07 Eriko Itoh, Sakiko Shimizu, Yasushi Ami, Yoichiro Iwase, Yuichi Someya
The live-attenuated oral polio vaccine has long been used as the standard for polio prevention, but in order to minimize the emergence of pathogenic revertants, the inactivated polio vaccine (IPV), which is administered intramuscularly or subcutaneously, is being increasingly demanded worldwide. However, there is a global shortage of IPV, and its cost is an obstacle in developing countries. Therefore
-
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses Biologicals (IF 1.7) Pub Date : 2023-04-05 Michele Machado Lencina, Uwe Truyen, Weslei de Oliveira Santana, Diéssy Kipper, Ana Paula Longaray Delamare, Suelen Paesi, Vagner Ricardo Lunge, André Felipe Streck
Canine parvovirus type 2 (CPV-2) is the etiological agent of a highly contagious and frequently fatal disease in dogs. Live attenuated vaccines (LAV) are recommended to prevent and control this disease. Commercial vaccines are typically produced with CPV-2 strains adapted to cell culture and usually non-pathogenic. The present study aimed to determine the viral load of CPV-2 vaccines commercially available
-
A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics Biologicals (IF 1.7) Pub Date : 2023-04-05 Qinqin Ji, Izabela Sokolowska, Rui Cao, Yulei Jiang, Jingjie Mo, Ping Hu
Host cell proteins (HCPs) are a major class of process-related impurities that need to be closely monitored during the production of biotherapeutics. Mass spectrometry (MS) has emerged as a promising tool for HCP analysis due to its specificity for individual HCP's identification and quantitation. However, utilization of MS as a routine characterization tool is still limited due to the time-consuming
-
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques Biologicals (IF 1.7) Pub Date : 2023-03-31 Mei M. Ho, Belinda Dagg, Sheila Govind, Jason Hockley
A need to develop an inactivated Mycobacterium tuberculosis (Mtb) preparation, to be used as a DNA standard, as an important and urgent requirement for Tuberculosis (TB) diagnostics standardization was identified in 2018. A candidate material was generated using a heat inactivated culture of Mtb strain H37Rv. A lyophilised preparation was evaluated for its suitability as an International Standard for