Author Archives:Yuval Shimoni

电子书:生物处理中的产品变体

产品变体是污染物,因为它们具有与所需的生物产品相对于活动,功效和安全性不同的特性。因此,这种变体可以损害产品质量和一致性。在这本电子书中,尤瓦尔·西莫尼(Yuval Shimoni)探索了不同类型的变体,包括主要的序列变体,不良的翻译后修饰,聚集体和降解蛋白质 - 并解释它们的存在如何降低药物和产品的性能和质量。他还讨论了产品变体如何在不同的...

Compounded Media Powder Streamlines Cell Culture Media Preparation Operations

细胞培养基对细胞生长,代谢和蛋白质表达至关重要。它提供了对细胞存活,生长和表达蛋白质和/或代谢产物的生长和表达至关重要的环境中的最佳pH值,渗透压和营养(1)。完整的培养基通常含有基本营养素,例如碳水化合物,氨基酸,脂质,盐,维生素,痕量金属,生长因子/激素(例如胰岛素),抗固定因子以及其他化学物质,这些化学因素以及其他促进细胞生长和蛋白质表达并可能稳定重组的化学物质蛋白质…

Product Quality Attribute Shifts in Perfusion Systems, Part 2: Elucidating Cellular Mechanisms

这两部分报告的第1部分描述了对潜在原因的研究以及控制灌注细胞培养中表达的蛋白质质量属性(PQA)的方法(1)。在尺寸排除高性能液相色谱(SEC-HPLC)之后,低分子量(LMW)物种的存在是一种蛋白质质量属性,可以表明表达蛋白质和/或其他LMW部分的截短形式增加。这项研究中表达的蛋白质是一种重度糖基化的重组糖蛋白(RGP),其中包括两个亚基:…

产品质量属性转移灌注系统,第1部分:确定发生时的转变

灌注细胞培养过程是连续的,新鲜的培养基连续添加并通过细胞保留装置同时消除了培养基(收获)(图1)。为了维持特定的生物反应器细胞密度,在细胞出血或丢弃时,定期去除细胞。灌注系统提供了比批处理和美联储文化模式的许多优势,例如较低的资本成本以及在更长的制造活动中支持更高的生存能力的较高的细胞密度,需要更短的转弯时间。但是,灌注系统需要复杂……

The Upstream Perspective: Taking Efficiency Beyond Cell-Line Development

With 20 years of experience in the biopharmaceutical industry — at Genentech, Applied Biosystems, Cell Genesys, Cellerant Therapeutics, and Bayer — Yuval Shimoni has written frequently for BioProcess International on a number of production topics. Those have ranged from process improvements and bioreactor scale-down validation, to raw materials management, to addressing variability and virus contamination events. For this featured report, we discussed hardware and instrumentation, quality by design (QbD) and related approaches, and other strategies that can take expediting upstream…

A Response Plan for Viral Contamination in Bioproduction Facilities

The biopharmaceutical industry uses living biological systems as a platform for manufacturing of protein-based drugs, vaccines, and other therapies derived from or consisting of different cell types. On one hand, living systems are inherently susceptible to viral infection and may harbor endogenous viruses, so the potential for such contamination cannot be eliminated. On the other hand, the industry has an excellent patient-safety record. Viral safety is achieved through three fundamental measures: prevention (e.g., by selection), removal (by clearance and/or reduction),…

降低灌注培养中细胞特异性生产率的变异性:案例研究

Variation in bioproduction is recognized in the industry and often attributed to one or more of four sources: raw materials (including consumables), operational inputs (measurements, methods, personnel, equipment), environmental factors, and biological variation inherent to living cells (1). Variability can occur even among replicate units regardless of production mode (e.g., fed-batch or perfusion), and it can manifest as variability in productivity, cell metabolism, and/or product quality (2–4). In commercial biomanufacturing, meeting all product quality attributes is a requirement for regulatory…

生物制药生产中使用的原材料的病毒风险评估

Ensuring a continuous supply of safe medicines to patients is a key objective for both health authorities and the pharmaceutical industry. A critical component to that end is maintaining a reliable supply of qualified raw materials (RMs). Manufacturers must ensure not only the suitability of RMs for their intended use in a manufacturing process, but also their highest attainable safety with regards to viruses and other adventitious agents. The need to apply a risk-based RM control strategy is in line…

A Risk-Based Approach to Supplier and Raw Materials Management

确保持续的供应安全的药物a key objective for the pharmaceutical industry and health authorities alike. A critical component to that end is maintaining a reliable supply of qualified raw materials (RMs) used in drug production. However, changes in suppliers, their processes, their providers, and consequently the materials they supply can occur (for a number of reasons) at any time during the life cycle of drug production. A product-supply organization therefore must be prepared to address such…

缩小生物反应器的资格:验证动物细胞衍生产品商业生产的过程变化,第2部分 - 应用

Here we apply our approach to validation of animal cell culture process changes using qualified, scale-down bioreactors. As described in Part 1 (including Table 1, Figures 1 and 2, and References 1–23), the goal is to facilitate implementation for the benefit of both the patients and industry. “Qualification of Scale-Down Bioreactors: Validation of Process Changes in Commercial Production of Animal-Cell–Derived Products, Part 1 — Concept” appears on pages 38–45 of BioProcess International’s May 2014 issue. Process changes often entail validation,…