Cui Wang,Shoumiao Wang,Shiyun Peng et al.
Cui Wang et al.
Endotoxins pose a significant risk to drug product safety due to their potent pyrogenic activity. However, developing a universal decontamination method for protein solutions remains challenging, as current technologies struggle to reconcil...
A mechanistic model for recombinant adeno-associated virus production dynamics in a helper virus-assisted producer cell line [0.03%]
辅助病毒作用下腺相关病毒生产细胞系中重组型腺相关病毒生产的动力学机理模型研究
Sha Sha,Patrick Hossler,Alexander Abrahamyan et al.
Sha Sha et al.
Recombinant adeno-associated virus (rAAV) is the most widely used viral vector for in vivo gene therapy, with over 200 clinical trials currently underway worldwide. Achieving a manufacturing process that is sufficiently productive with the ...
Continuous concentration and diafiltration tangential flow filtration with scalable dual membrane technology [0.03%]
连续浓缩和透析膜过滤技术及可扩展性双膜技术
Alexander Helling,Ehsan Espah Borujeni,Martin Leuthold et al.
Alexander Helling et al.
Intensified, integrated, and continuous bioprocessing are key trends in current biologics biomanufacturing. They model more efficient and economical production in upstream and downstream processes. Continuous or single-pass (SP) tangential ...
Generation of high-expressing transposon-based stable pools to produce (1 + 1) and (2 + 1) bispecific common light chain antibodies [0.03%]
用于制备(1+1)和(2+1)型双特异性抗体的高表达转座子稳定细胞库的构建
Sara Ramos,Surya Karunakaran,Thierry Monney et al.
Sara Ramos et al.
Bi- and multispecific antibodies can deliver effective protein-based therapeutics by enabling novel biology. Transient expression of these complex asymmetric antibody formats may become a bottleneck in providing sufficient amounts of high-q...
Binding of bacteria to magnetic nanoparticles in suspension: Experiments and kinetic models [0.03%]
悬浮磁性纳米粒子对细菌的结合：实验与动力学模型
Bowen J Houser,Camille A Bryner,Aaron D Rappleyea et al.
Bowen J Houser et al.
With the rise of antimicrobial-resistant and multi-drug-resistant bacteria, the use of magnetic nanoparticles (MNPs) has become a promising tool for separation processes in conjunction with in vitro diagnostics for the rapid identification ...
Machine learning-assisted clone selection for intensified cell culture processes [0.03%]
机器学习辅助的克隆选择在增强型细胞培养过程中的应用
Nicolas Wolnick,John Schmitt,Christian Siltanen et al.
Nicolas Wolnick et al.
Intensified fed-batch processes are becoming increasingly prevalent among biomanufacturers due to their superior space-time yields relative to traditional, non-intensified fed-batch processes. However, the shift towards intensified manufact...
β-1,4-galactosyltransferase 1 inhibitors modulate cellular N-glycan profiles [0.03%]
β-1,4-半乳糖基转移酶1抑制剂可调节细胞N-聚糖谱型
Jaka Kranjc,Stane Pajk,Marko Anderluh et al.
Jaka Kranjc et al.
N-glycosylation is a key post-translational modification of proteins influencing their physicochemical properties as well as biological activity. This study investigates the in vivo activity of four β-1,4-galactosyltransferase 1 inhibitors...
Multivariate phase-dependent optimization of bioprocesses boosts performance and quality-Why timing (of exposure) matters [0.03%]
多变量相依赖的生物工艺优化提高性能和质量-为何时机(暴露时间)很重要
Samuel Kienzle,Lisa Junghans,Anja Wittmann et al.
Samuel Kienzle et al.
Applying a single parameter set to describe complex mammalian kinetics often is too simplistic, as it fails to capture sensitive cell-to-environment interactions that may be exploited to optimize production performance. To resolve this time...
NS0 and CHO cell lines generate distinct quality profiles for non-originator NISTmAbs [0.03%]
NS0和CHO细胞系产生不同的质量谱以用于非原研NIST单克隆抗体
Xin Bush,Nicole Azer,JungHyun Kim et al.
Xin Bush et al.
The selection of host cell lines and culture media plays a central role in influencing the quality attributes of monoclonal antibodies, particularly in biosimilar development and process comparability. This study used standardized upstream ...
Improved methodology for direct monitoring of large-scale manufacturing cell culture using Raman spectroscopy data from process development [0.03%]
基于过程开发中拉曼光谱数据的大型生产细胞培养直接监测方法改进
Hadi El Radi,Hui Chen,Xiande Su et al.
Hadi El Radi et al.
Process analytical technology (PAT) is a framework that encourages the implementation of analytical tools for real-time monitoring of critical batch components during the production of pharmaceuticals. In mammalian cell cultures, Raman spec...