定义一种通用的技术转让流程,用于整个生物制药制造业
Jonathan Moore1, Diana Chinchilla-Olszar2, Mary Switzer3
1Biopharmada; Gaithersburg MD, USA.
PDA journal of pharmaceutical science and technology
|July 15, 2025
概括
生物制药技术转让过程缺乏标准化,阻碍了合作. 本文定义了一种通用流程,以提高整个行业的效率和沟通.
科学领域:
- 生物制药制造业 生物制药制造业
- 工艺工程是过程工程.
- 技术转让 技术转让 技术转让
背景情况:
- 在生物制药行业,技术转让流程的差异很大,导致复杂性和沟通问题.
- 缺乏标准化和不断变化的行业要求,造成效率低下和障碍组织间协作.
- 工业的快速发展,新的工艺 (如连续加工,新模式) 需要更加统一的方法.
研究的目的:
- 定义适用于整个生物制药行业的通用技术转让流程.
- 提供一个基础框架,组织可以适应和建立在上面.
- 解决生物制药制造工艺日益复杂和分歧的问题.
主要方法:
- 从广泛的行业主题专家那里收集的投入.
- 制定技术转让过程的标准化,通用定义.
- 专注于创建一个普遍适用的框架,而不是特定的公司.
主要成果:
- 已经建立了一个定义的通用技术转让流程.
- 该过程旨在缓解因不同的组织方法造成的低效率.
- 为改善技术转让实践提供了一个共同的起点.
结论:
- 标准化,通用技术转让流程对于不断发展的生物制药行业至关重要.
- 这种由NIIMBL赞助的定义为加强协作和效率提供了基础.
- 进一步开发和采用这种通用工艺可以简化生物制药制造转让.
相关概念视频
Plant Breeding and Biotechnology
19.8K
Crop cultivation has a long history in human civilization, with records showing the cultivation of cereal plants beginning at around 8000 BC. This early plant breeding was developed primarily to provide a steady supply of food.
19.8K
Transgenic Organisms
31.6K
Overview
31.6K
Types of Genetic Transfer Between Organisms
29.5K
Genetic transfer occurs when genetic information is passed from one organism to another. It occurs via two mechanisms: vertical gene transfer and horizontal gene transfer. Vertical gene transfer occurs when genetic information is transferred from one generation to the next, which happens much more frequently than horizontal gene transfer. Both sexual and asexual reproduction are forms of vertical gene transfer, where one or more organisms pass some or all of their genome onto their progeny.
29.5K
Horizontal Gene Transfer
151
Horizontal gene transfer (HGT) is a process where genetic material moves between organisms within the same generation, unlike vertical gene transfer, which occurs from parent to offspring. HGT plays a crucial role in microbial evolution, adaptation, and survival, particularly in shared environments like the human gut.Mobile genetic elements such as plasmids, prophages, integrons, insertion sequences, and transposons facilitate this process. HGT occurs through three primary mechanisms:...
151
Bioequivalence: Overview
1.2K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.2K
Drug Biotransformation: Overview
2.9K
Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...
2.9K


