Biopharmaceutical 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. ...
Creative Bioarray has extensive experience in characterizing cGMP cell banks for biopharmaceutical production, offering a broad range of cell line characterization services that allow researchers to efficiently streamline cGMP-compliant manufacturing and accelerate successful commercialization. ...
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 process is over, the ...
Scientists from Creative Proteomics are professional and experienced in metabolites analysis and pharmacokinetic analysis of biological pharmaceutical products. Creative Proteomics offers different aspects of service including metabolites separation, metabolites identification and immunological assay & biological assay for pharmacokinetic analysis. In addition, we can provide ...
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. ...
Individuals with these conditions often suffer from insufficient endogenous enzyme production. Native Porcine Pancreatin supplements provide exogenous enzymes to help alleviate digestive issues and nutrient malabsorption. ...
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. ...
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. ...
Creative Bioarray has extensive experience in characterizing cGMP cell banks for biopharmaceutical production, offering a broad range of cell line characterization services that allow researchers to efficiently streamline cGMP-compliant manufacturing and accelerate successful commercialization. ...
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 ...
Medicine production starts in a lab, where cells are cultured and bacteria fermented in small batches. ...
Sponsored by ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and LyoHUB, the workshop will be held at the Indiana Manufacturing Institute at Purdue University in West Lafayette, IN, in conjunction with the October standards development meetings of Committee E55. ...
We employ metafrontier analysis to estimate the production metafrontier technical efficiency during the period 1989–2007. ...
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, ...
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 for qualified personnel, its results are ...