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Production In Biopharma 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 services have been developed to streamline this process. The Significance ...
Polydisperse PEG: Conventional PEGs are polydisperse mixtures (a range of chain lengths), which can yield heterogeneous ADC products. In contrast, monodispersed PEGs are uniform chains with a single defined molecular weight. ...
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 biopharmaceuticals derived from them. This article will explore 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. This testing is crucial because these host cell proteins (HCPs) may impact the safety, efficacy, and quality of drug products.In the fields of biotechnology and ...
After the production process is over, the product needs to go through multiple purification steps to remove non-target impurities, one of which is the protein of the host cell. ...
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. The result can be used to guide the screening and development of drugs, and support the evaluation of their ...
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. This article will explore the in-depth process and importance of stable cell line development in bioproduction. The ...
Native Porcine Pancreatin, an enzymatic mixture derived from the porcine pancreas, has emerged as a fundamental component in various industries due to its unique enzymatic composition. Comprising amylase, lipase, and protease enzymes, this preparation is celebrated for its multifaceted applications and plays an indispensable role in the pharmaceutical, food, and biotechnology sectors. In this ...
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. Enzyme-linked immunosorbent assay (ELISA) has traditionally been used to monitor the total content of HCP in the production of therapeutic protein drugs. Now, with the continuous improvement and upgrading of technology, liquid ...
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 ...
Bertozzi's team developed an anti-HER2 antibody around glycans that binds to sialase, which binds to these sugars on the surface of cancer cells, allowing the immune system to recognize and attack the cancer cells. 2. Improve ADC production In recent years, scientists have developed a new class of targeted drugs - antibody-drug conjugate (ADC). ...
Medicine production starts in a lab, where cells are cultured and bacteria fermented in small batches. When it’s time to move to industrial-scale production, Abec – a supplier of bioreactors and fermenters – employs advanced simulation software from Siemens. Abec, a supplier of bioreactors and fermenters, employs advanced simulation software from Siemens ...
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. This makes the work of technical transference and validation easier in the last stages. Although the application of this methodology is time consuming ...