Host cell protein profiling and immunogenicity assessment in E. coli-produced interferon beta [0.03%]
大肠杆菌生产的干扰素β的宿主细胞蛋白谱分析及免疫原性评估
Florencia Rivarosa,Lucía C Peña,Marina Etcheverrigaray et al.
Florencia Rivarosa et al.
Host cell proteins (HCPs) are critical process-related impurities in biotherapeutic products and may impact product safety and efficacy. Although Escherichia coli expression systems are widely used for recombinant protein production, system...
From barriers to cloud-based regulatory collaboration: An industry perspective on accelerating innovation in pharmaceutical manufacturing [0.03%]
从壁垒到基于云的监管协作：加速制药制造创新的行业视角
Nina S Cauchon,Marquerita Algorri,Kabir Ahluwalia et al.
Nina S Cauchon et al.
Pharmaceutical manufacturing is changing rapidly as new therapeutic modalities, advanced manufacturing approaches, modern analytical tools, and novel drug-delivery technologies continue to emerge. While the scientific and technical potentia...
Enhancing lyophilized cake morphology in biopharmaceutical products through stepped annealing at freezing phase [0.03%]
通过冻结相的分步退火增强生物制药产品的冻干饼形态学
Prashant Birangal,Anurag Lodagekar,Mallikarjuna Pulipeta et al.
Prashant Birangal et al.
Lyophilization is widely used to stabilise biopharmaceuticals, yet split‑cake formation remains a challenge. Cake elegance, a critical quality attribute (CQA), is influenced by both formulation and process parameters. As biosimilar manufac...
Platform technology and alternates for cross-linking issues in soft gelatin capsules: A modified shell composition strategy for BCS class IV drug candidates [0.03%]
软胶囊交联问题的平台技术和替代方案：BCSⅣ类药物候选者的改良壳体组成策略
Kaliyamoorthy Senthilraja,A T Rajasekhar,Mohamed Arif Ansari et al.
Kaliyamoorthy Senthilraja et al.
Soft gelatin capsules (softgels) are widely used oral dosage forms for BCS Class IV drug candidates, offering enhanced solubilization capacity for poorly soluble, poorly permeable active pharmaceutical ingredients. However, gelatin shells a...
Extractables and leachables predictive modeling for pharmaceutical products risk management: A call for broader regulatory acceptance [0.03%]
药品产品的提取物和浸出物预测建模用于风险管理：更广泛地接受监管的呼吁
Alicja Sobantka,Georg Pour,Yemin Liu et al.
Alicja Sobantka et al.
Modeling approaches for determination of extractables and leachables in (bio)pharmaceutical products are a growing area of applied technology and innovation. Modeling, to support predictions related to leachables (migrants) levels, is appli...
Analysis of molecular weight of mixed poly (lactide-co-glycolide) in Risperidone microspheres based on separation method [0.03%]
基于分离法的利培酮微球用混合聚乳酸-乙醇酸分子量分析研究
Shulin Chen,Jiahui Ma,Yongchao Ma et al.
Shulin Chen et al.
Poly(lactide-co-glycolide) polymers (PLGAs) are indispensable biodegradable matrices for long-acting parenteral (injectable) microsphere formulations. To modulate drug release kinetics and mitigate burst release in these complex injectable ...
Buccal film drug delivery: Linking formulation design with pharmacokinetic control and clinical translation [0.03%]
颊膜给药系统：从制剂设计到药代动力学控制及临床转化
Yogesh N Joshi,Arnavaz Akhzarmehr,Hossein Omidian
Yogesh N Joshi
Buccal film drug delivery systems have evolved from experimental formulations to clinically relevant platforms capable of enabling rapid, controlled, and targeted drug administration. By bypassing hepatic first-pass metabolism and allowing ...
Step-by-step optimization of a colchicine-loaded nanoemulgel for superior topical therapy of acute gouty arthritis [0.03%]
一种用于急性痛风性关节炎的优效外用疗法的秋水仙碱纳米乳凝胶一步优化法
Jian Zhang,Xiaqian Xu,Anqi Zhu et al.
Jian Zhang et al.
A colchicine-loaded nanoemulgel (COL-nEMG) was developed for rapid and potent topical therapy of acute gouty arthritis (AGA). An O/W COL-loaded nanoemulsion (COL-nEMS, 14.20 ± 1.73 nm) was first prepared and optimized step by step, includi...
Intraperitoneal route of administration: Present understanding and future usage [0.03%]
腹腔给药途径：当前认知与未来应用
Jack Terry,Michael Hageman
Jack Terry
Intraperitoneal (IP) administration of drugs is a long-recognized route of administration but seldom routinely used outside of pharmacology screening in various rodent models. Hence, the scientific understanding and research investigation h...
Quantitative assessment of the influence of tapered dies and compaction position on the propensity of lamination due to air entrapment during pharmaceutical compression [0.03%]
药片压缩过程中型腔锥度和压制位置对裹入空气导致层裂倾向影响的定量评估方法研究
Charbel Madi,Johny Bertels,Vincent Mazel
Charbel Madi
Air entrapment is a primary cause of tablet lamination, yet the quantitative impact of specific tooling variables remains underexplored. This study investigates the influence of tapered dies and compaction position on lamination type 1 usin...