Biopharmaceutical Process And Product Articles & Analysis
19 articles found
In the ever-evolving field of biopharmaceuticals, the production of antibodies has taken center stage due to their critical role in therapeutic applications. Among the various production systems available, Chinese Hamster Ovary (CHO) cells have emerged as a gold standard for monoclonal antibody production, and specialized ...
Antibody-drug conjugates (ADCs) combine potent small-molecule drugs with monoclonal antibodies for targeted cancer therapy. A major challenge is loading enough drug onto each antibody without compromising solubility or circulation time. Introducing polyethylene glycol (PEG) linkers between the antibody and drug payload can address this. PEG is hydrophilic, biologically inert, and FDA‐recognized ...
Introduction Good Manufacturing Practice (GMP) cell banks play a crucial role in the biopharmaceutical industry, serving as foundational repositories of cell lines used for the production of therapeutic biological products. Characterization of these cell banks is essential to ensure the safety, efficacy, and consistency of the ...
Human brain has approximately 171 billion cells, of which slightly more than half (approximately 86 billion) are nerve cells. These 86 billion nerve cells are a diverse cell population with hundreds of specialized types and functions, but all originate from three neural cell lineages--neurons, oligodendrocytes and astrocytes. All three cell lineages originate from a pool of neural stem and ...
Host cell protein (HCP) residual detection refers to the testing of proteins that may remain in the final product and originate from the production cell line (i.e., the "host") during the biopharmaceutical production process. ...
Host protein residue detection is an important quality control step in the biopharmaceutical process. In biopharmaceuticals, cell lines (hosts) are typically used to produce proteins or other biological products. These cell lines could be bacteria, yeast, mammalian cells, etc. After the production ...
Therapeutic monoclonal antibodies (mAbs) are a class of antibody drugs that are highly uniform and have pharmacological effects against a single epitope obtained through molecular biology. In the process of new drug development, the study of pharmacokinetics is of great significance. ...
Bioproduction is a critical element in the creation of many vaccines, therapeutics, and other biopharmaceuticals. A central facet of this process involves the development of stable cell lines that are capable of producing these vital products in abundance and with consistency. ...
Amylase, by catalyzing starch hydrolysis, improves dough texture and facilitates yeast fermentation, thus enhancing the overall quality of baked products. Brewing: The enzymatic action of amylase and protease in Native Porcine Pancreatin is pivotal in brewing processes. ...
Harnessing the power of cell biology, scientists across the globe are perpetually invested in the pursuit of understanding the complexities of cellular mechanisms and their adaptability. One such venture is the creation of Inducible Expression Stable Cell Line (IESCL) development. IESCL signifies a consolidated methodology designed to explore the potentialities of modulated gene expression. This ...
Host cell proteins (HCPs) are process-related impurities produced by host cells and are typically present at low levels in recombinant biopharmaceutical products. ...
Large-scale production of AAV vectors is a multifaceted and critical ordeal of gene therapy production, and understanding the intricate processes is essential for successful scalability and commercial viability. ...
Human brain has approximately 171 billion cells, of which slightly more than half (approximately 86 billion) are nerve cells. These 86 billion nerve cells are a diverse cell population with hundreds of specialized types and functions, but all originate from three neural cell lineages--neurons, oligodendrocytes, and astrocytes. All three cell lineages originate from a pool of neural stem and ...
What is "click chemistry"? "Click Chemistry", this is a literary name given to this kind of reaction by the Nobel Prize winner K.Burry Sharless, when the cards are put together, "click" (click). Simply put, it is to add two structures to two molecules respectively, and these two structures can be specifically combined to synthesize the required chemical molecules. One of the most famous ...
Abec, a supplier of bioreactors and fermenters, employs advanced simulation software from Siemens to help its customers scale up biopharmaceutical production. Every medicine starts out in a lab, developed and tested in small batches until it is ready to be produced in large quantities – that is, until production can be scaled up. ...
Get up close and personal with a Computrac Vapor Pro XL at the 2018 LyoHUB/ASTM E55 Workshop on Pharmaceutical Manufacturing Research. For full information and registration info, visit www.astm.org/E55WorkshopOct2018. You must register by 10/10/18 to attend. About the Event The Workshop on Pharmaceutical Lyophilization will be held Tuesday, October 23, 2018. Sponsored by ASTM Committee E55 on ...
This article estimates the production technical efficiency of pharmaceutical companies and biotechnology companies under heterogeneous technologies. We employ metafrontier analysis to estimate the production metafrontier technical efficiency during the period 1989–2007. When using traditional stochastic frontier analysis, the results show that the technical efficiency of the biotechnology ...
Nanobiotechnology refers to the ability to create and manipulate biological and bio-chemical materials, devices, and systems at atomic and molecular levels. Nano delivery systems hold great potential to overcome some of the obstacles in bio-pharmaceutical production, such as water soluble/insoluble pharmaceutical drugs and cosmetic ingredients, risks of toxicity, increasing bio-active efficacy, ...
Process characterisation is an important aspect of any validation program. This article presents arguments on how process characterisation should be integrated to the process of Research & Development (R&D) itself of a biopharmaceutical product. ...