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Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (serum half-life and specificity) whilst further improving efficacy and safety and to open new and better avenues for treating patients, e.g., improving the potency of molecules, target binding, tissue penetration, tailored pharmacokinetics, and reduced adverse effects or immunogenicity.The next generation of biopharmaceuticals can pose specific chemistry, manufacturing, and control (CMC) challenges. In contrast to conventional proteins, next-generation biopharmaceuticals often require lyophilization of the final drug product to ensure storage stability over shelf-life time. In addition, next-generation biopharmaceuticals require analytical methods that cover different ways of possible degradation patterns and pathways, and product development is a long way from being straight forward. The element of "prior knowledge" does not exist equally for most novel formats compared to antibodies, and thus the assessment of critical quality attributes (CQAs) and the definition of CQA assessment criteria and specifications is difficult, especially in early-stage development.
This article was published in the following journal.
Name: Advances in biochemical engineering/biotechnology
To demonstrate a biological product is biosimilar to a reference product, the applicant needs to show that the product is highly similar and has no clinically meaningful differences. Comparative clini...
Development of optimal drug product lyophilization cycles is typically accomplished via multiple engineering runs to determine appropriate process parameters. These runs require significant time and p...
Physicochemical and structural properties of proteins used as active pharmaceutical ingredients of biopharmaceuticals are determinant to carry out their biological activity. In this regard, the assays...
The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing...
In this study, shrimp waste was enzymatically hydrolyzed to generate a green dispersant and the product was tested for crude oil dispersion in seawater. The hydrolysis process was first optimized base...
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This is a randomized, double-blind, study in healthy volunteers dosed to steady state with fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet manufactured by...
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An antiprotozoal agent produced by Streptomyces cinnamonensis. It exerts its effect during the development of first-generation trophozoites into first-generation schizonts within the intestinal epithelial cells. It does not interfere with hosts' development of acquired immunity to the majority of coccidial species. Monensin is a sodium and proton selective ionophore and is widely used as such in biochemical studies.
Form in which product is processed or wrapped and labeled. PRODUCT LABELING is also available.
The removal of a consumer product from the market place. The reason for the removal can be due a variety of causes, including the discovery of a manufacturing defect, a safety issue with the product's use, or marketing decisions.
Systems of medicine based on cultural beliefs and practices handed down from generation to generation. The concept includes mystical and magical rituals (SPIRITUAL THERAPIES); PHYTOTHERAPY; and other treatments which may not be explained by modern medicine.
A unit of the National Institutes of Health that seeks to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Center was established in 2011.
BioPortfolio lists over 550 biotechnology products - please open http://www.bioportfolio.com/channels?category_id=5 Direct topic pages: Actos Advair Biopharmaceuticals Biosimilars Biotherapeutics GMO Crops Lipitor ...
Biotechnology - Biotech
"using living things to create products or to do tasks for humans" About Biotechnology - Biotech Biotechnology is the practice of using plants, animals and micro-organisms such as bacteria, as well as biological processes - such as the ripen...