Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure [0.03%]
下游工艺中使用小孔病毒滤器过滤生物治疗产品的效果：操作压力的影响
Na Liu,Tiandan Xu
Na Liu
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 ...
Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh [0.03%]
在孟加拉国发现SARS-CoV-2变异株B.1.525（埃塔）
Barna Goswami,Md Murshed Hasan Sarkar,Shahina Akter et al.
Barna Goswami et al.
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) ...
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2 [0.03%]
SARS-CoV-2检测的优化RT-LAMP测试的开发
Navid Momenifar,Mohammad Pirouzfar,Zohreh Hashemian et al.
Navid Momenifar et al.
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...
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 [0.03%]
一种针对安荣安荣病毒检测的实时RT-PCR测定方法的外部质量控制和内部质量控制的建立与评估
Hai-Bo Wang,Tian Du,Ji-Hong Lin et al.
Hai-Bo Wang et al.
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 polyme...
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states [0.03%]
世界卫生组织西太平洋区和东南亚区国家生物制品检定实验室第七次会议报告
Sun Bo Shim,Chan Woong Choi,Jin Ho Shin et al.
Sun Bo Shim et al.
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 ...
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing [0.03%]
生物制药即用型制造风险评估：上游连续加工情况研究
Takao Ito,Hui Wang,Soon-Hwa Hwang et al.
Takao Ito et al.
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 a...
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 [0.03%]
基于反向疫苗学方法的绵羊脑肺病病毒多表位亚单位疫苗候选抗原的理性设计与鉴定
Ecem Su Koçkaya,Hüseyin Can,Yalçın Yaman et al.
Ecem Su Koçkaya et al.
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 v...
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab [0.03%]
一种抗VEGF单克隆抗体(PRO-169)的糖基化差异及其与贝伐珠单抗的全面比较分析
Mayra G Quiñonez-Alvarado,Paulina Chávez-Hurtado,Jesús C Caro-Palomera et al.
Mayra G Quiñonez-Alvarado et al.
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 tha...
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China [0.03%]
我国基于脂质纳米颗粒递送的mRNA疫苗质量评价的考量因素及监管路径思考
Jiaqi Lu,Wei Wei,Wu He
Jiaqi Lu
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 agen...
Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test [0.03%]
破伤风类毒素国际标准效价测定协作研究及相关替代品的建立
Rob Tierney,Jason Hockley,Shalini Rajagopal et al.
Rob Tierney et al.
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 floc...