Direct Analysis of Subvisible Particles in Pharmaceutical Drug Products with Non-invasive Mie-scattering Light Sheet Technology: Profiling Inherent Particle Growth in Monoclonal Antibody Solutions [0.03%]
采用非侵入式Mie散射薄片光技术直接分析药物产品中的亚可见颗粒：单克隆抗体溶液中固有颗粒增长表征
Benjamin Laccetti,Mingshu Liang,Monica Goss et al.
Benjamin Laccetti et al.
Enumerating and sizing subvisible particles (SbVP) is an important aspect of ensuring pharmaceutical drug product (DP) quality. Existing SbVP characterization is limited by the destructive nature of testing methods and the need to withdraw ...
Generalized flow imaging microscopy instrument settings for measuring subvisible particle sizes and concentrations in protein therapies [0.03%]
蛋白质治疗中亚可见颗粒大小和浓度测定的广义流动成像显微镜仪器设置
Austin L Daniels,Sushma Parab,Sigrid C Kuebler et al.
Austin L Daniels et al.
Flow imaging microscopy (FIM) is a common imaging-based technique for measuring the subvisible particle content of protein therapies. FIM measurement accuracy strongly depends on particle segmentation, the process of detecting particles in ...
Do we worry too much about polysorbate degradation? An industry-wide perspective with real-life case studies [0.03%]
聚山梨酯降解问题真的需要担忧吗？来自行业的广泛观点及真实案例分析
Klaus Wuchner,Felix Nikels,Patrick Garidel et al.
Klaus Wuchner et al.
Polysorbates are commonly used in biotherapeutic drug formulations, but their stability over the course of the product's shelf life is a matter of concern. An industry-wide survey involving 15 biopharmaceutical companies found that 23 bioth...
Control strategy for subvisible particulates of therapeutic protein injections in pre-filled syringes using flow imaging [0.03%]
流动成像法在预装注射器中治疗蛋白药物亚可见颗粒控制策略的研究
Bin Zhang,Katiria Flores,Nathyn Horvath et al.
Bin Zhang et al.
Pre-filled syringes (PFSs) are a widely used container closure for therapeutic protein injections, enabling simplified preparation and at-home administration. PFSs are commonly lubricated with sprayed-on silicone oil (SiO), which may migrat...
Long-acting delivery of a model monoclonal antibody from ethylene vinyl acetate implants at a high loading: Drug release and protein stability [0.03%]
乙烯基乙酸酯植入剂中高载药量模型单克隆抗体的长效递送：药物释放和蛋白稳定性研究
Yu Tong Tam,Harsh Patel,Jeffrey C Haley et al.
Yu Tong Tam et al.
Delivering large therapeutic monoclonal antibodies (mAbs) from solid polymer matrices via hot-melt extrusion (HME) is a promising approach to achieving a prolonged release profile. However, this approach presents significant challenges due ...
A comprehensive discussion on analytical method development and validation of a USP type-IV dissolution method for dexamethasone in a combination ophthalmic suspension with povidone-iodine [0.03%]
一种用于含聚维酮碘的十二烷基甲基硫酸钠-氢化可的松组合眼用悬浮液的USP IV溶出度方法的开发与验证的全面讨论
Likhit Mandal,Dr Praveen Kumar Vemuri
Likhit Mandal
Antimicrobial resistance resulting from the widespread use of topical antibiotics has accelerated the need for non-antibiotic strategies in ocular therapy. Povidone-iodine (PVP-I) offers broad antimicrobial activity without inducing resista...
Analysis of the formation of (sub)visual particles in ready-to-administer trastuzumab infusion bags during transport from the hospital pharmacy to patients at home [0.03%]
透析曲妥珠单抗输注袋中(sub)视觉颗粒的形成分析：从医院药房到患者家庭运输过程中
Charlotte Sikking,T Ton Dinh,Mirjam Crul et al.
Charlotte Sikking et al.
For biological drugs, subvisible particle formation can cause loss of efficacy of the drug or trigger immune reactions. Transport of ready-to-administer infusion bags, to enable home treatment of cancer patients, might cause particle format...
Ionic strength mitigates solvent/detergent-induced tertiary expansion of hemopexin [0.03%]
盐强度可减轻溶剂/清洁剂诱导的转铁蛋白受体三级结构扩张效应
Min-Jung Kim,Jae Eun Jung,Jieun Kang et al.
Min-Jung Kim et al.
Hemopexin (Hx) is a plasma glycoprotein that scavenges free heme with sub-nanomolar affinity and under development as a therapeutic. Solvent/detergent treatment (S/D) is routinely applied to plasma-derived manufacturing for viral safety and...
A novel bicyclic peptide-drug conjugate of 3-fluoro-10-hydroxy-evodiamine for targeted colorectal cancer therapy [0.03%]
一种新型二环肽药物缀合物3-氟-10-羟基叶秋碱用于结直肠癌靶向治疗
Siyuan Zhao,Chang Chu,Cuiping Li et al.
Siyuan Zhao et al.
This study aimed to develop a novel peptide-drug conjugate (PDC) by conjugating 3-fluoro-10-hydroxy-evodiamine (FOE) with a bicyclic peptide (BiP) targeting the EphA2 receptor. The goal was to enhance the solubility, tumor selectivity, and ...
Investigating the SNAC-to-drug ratio for the oral absorption of cyanocobalamin in rats [0.03%]
考察氰钴胺在大鼠口服吸收过程中SNAC-药物比例的研究
Po-Chang Chiang,Jia Liu,Karthik Nagapudi et al.
Po-Chang Chiang et al.
The oral route of administration continues to be the preferred and most convenient method for drug delivery among both patients and healthcare professionals. This preference is based not only on its user-friendliness but also on the practic...