通过引入下游加工的新型多层分类来审查工艺强化格局
Louis Crowley1, Paul Cashen2, Marc Noverraz2
1Sartorius Stedim North America Inc, Bohemia, New York, USA.
Biotechnology and bioengineering
|January 12, 2024
概括
生物制药制造中的工艺强化提供了好处,但面临着采用挑战. 本研究提出了一种标准化,平衡的方法来实施下游过程强化,使增量和成本效益的采用.
科学领域:
- 生物制药制造业 生物制药制造业
- 工艺工程的过程工程.
- 生物技术是生物技术.
背景情况:
- 对生物制药的需求不断增加,推动了对工艺强化需求的增长.
- 目前采用工艺强化被复杂性,成本和不清楚的术语所阻碍.
- 现有的文献缺乏标准化的方法,导致该领域的混乱.
研究的目的:
- 解决在生物制造中采用工艺强化所面临的挑战.
- 提出一个定义的,平衡的方法来实施下游工艺强化.
- 为了明确和一致的应用,引入标准化命名法.
主要方法:
- 综合审查最先进的系统和耗材.
- 对生物制造当前工艺强化案例研究的分析.
- 制定一个分层实施战略,使用标准化术语.
主要成果:
- 建议为工艺强化提供一个明确的,标准化的命名体系.
- 过程强化可以逐步实现,作为不同的,独立的层面.
- 这种方法为各种规模的生物制造商提供了具有成本效益的采用.
结论:
- 拟议的平面化方法简化了采用过程强化.
- 标准化命名法减少了混,并促进了一致的应用.
- 这一战略使生物制药生产中可扩展和经济地实施工艺强化.
相关概念视频
Classification of Systems-I
Linearity is a system property characterized by a direct input-output relationship, combining homogeneity and additivity.
Homogeneity dictates that if an input x(t) is multiplied by a constant c, the output y(t) is multiplied by the same constant. Mathematically, this is expressed as:
Homogeneity dictates that if an input x(t) is multiplied by a constant c, the output y(t) is multiplied by the same constant. Mathematically, this is expressed as:
Classification of Systems-II
Continuous-time systems have continuous input and output signals, with time measured continuously. These systems are generally defined by differential or algebraic equations. For instance, in an RC circuit, the relationship between input and output voltage is expressed through a differential equation derived from Ohm's law and the capacitor relation,
Upstream Processing
Upstream processing represents a critical phase in biomanufacturing, wherein biological systems such as microorganisms, mammalian cells, or insect cells are cultivated to produce therapeutic proteins, vaccines, enzymes, or other biologically derived products. This phase encompasses all steps from the selection and genetic manipulation of the production organism to the cultivation of cells in bioreactors under tightly controlled environmental conditions.Host Selection and Genetic OptimizationThe...
Downstream Processing
Downstream processing begins once fermentation is complete and involves a series of steps to recover and purify products such as acids, vitamins, antibiotics, or proteins.Cell HarvestingFor example, for intracellular protein-based products, the first step is harvesting the cells. This is typically achieved using centrifugation or filtration to separate the cells from the liquid phase.Cell Disruption for Intracellular ProductsIf the target product is intracellular, the harvested cells must be...


