Defining a Generic Technology Transfer Process for use Across the Biopharmaceutical Manufacturing Industry
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
View abstract on PubMed
Summary
This summary is machine-generated.Biopharmaceutical technology transfer processes lack standardization, hindering collaboration. This paper defines a generic process to improve efficiency and communication across the industry.
Area Of Science
- Biopharmaceutical Manufacturing
- Process Engineering
- Technology Transfer
Background
- Technology transfer processes vary significantly across the biopharmaceutical industry, leading to complexity and communication issues.
- Lack of standardization and evolving industry requirements create inefficiencies and barriers to inter-organizational collaboration.
- Rapid industry evolution with novel processes (e.g., continuous processing, new modalities) necessitates a more unified approach.
Purpose Of The Study
- To define a generic technology transfer process applicable across the biopharmaceutical sector.
- To provide a foundational framework that organizations can adapt and build upon.
- To address the increasing complexity and divergence of biopharmaceutical manufacturing processes.
Main Methods
- Input gathered from a broad range of industry subject matter experts.
- Development of a standardized, generic definition of the technology transfer process.
- Focus on creating a universally applicable framework, not company-specific.
Main Results
- A defined generic technology transfer process has been established.
- The process aims to mitigate inefficiencies caused by disparate organizational methods.
- Provides a common starting point for improving technology transfer practices.
Conclusions
- A standardized, generic technology transfer process is essential for the evolving biopharmaceutical industry.
- This NIIMBL-sponsored definition offers a foundation for enhanced collaboration and efficiency.
- Further development and adoption of this generic process can streamline biopharmaceutical manufacturing transfers.
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
Related Concept Videos
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.
As humans' understanding of genetics advanced, improved crop varieties could be achieved more quickly. Artificial selection could be more directed, and crop varieties enhanced for favorable traits more quickly to produce better, more robust, or more palatable...
Overview
Transgenic organisms are genetically engineered to carry transgenes—genes from a different species—as part of their genome. The transgene may either be a different version of one of the organism’s genes or a gene that does not exist in their genome. Transgenes are usually generated by recombinant DNA and DNA cloning techniques. Transgenic bacteria, plants, and animals allow scientists to address biological queries and design practical solutions.
Creating a...
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.
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:...
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,...
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...