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Biopharmaceutical Landscape
This chapter traces the rapidly expanding clinical-develo** and market-approved biopharmaceutical portfolio. Although biological medicines have...
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Innovations in the Cyanobacteria-Based Biorefineries for Biopharmaceutical Industries
The biopharmaceutical industry witnesses exceptional growth globally since their emergence. It revitalizes our ability to combat antimicrobial...
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Biopharmaceutical Critical Quality Attributes
Manufacturers must ensure that the quality of their medicines, both for the drug substance (DS) and for the drug product (DP), meet all of the...
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Manufacturing the Biopharmaceutical Drug Product
Manufacture of the finished drug product is the last process step (from starting materials to drug substance and now to drug product) for the...
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Downstream Purification of the Biopharmaceutical Drug Substance
The upstream production process has been designed to yield the intended biopharmaceutical. But the upstream design carries with it a complex impurity...
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The Challenge of Demonstrating Biopharmaceutical Product Comparability
Manufacturers need the freedom to make changes for improving their biopharmaceutical processes, not only during clinical development, but also for...
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Upstream Production of the Biopharmaceutical Drug Substance
Upstream production of the biopharmaceutical drug substance involves living cells – whether it is living recombinant cells that express a recombinant...
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Starting Materials for Manufacturing the Biopharmaceutical Drug Substance
Starting materials (also referred to as source materials) are the starting point for cGMP manufacturing of the biopharmaceutical drug substance. Some...
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Mammalian Cell Culture: An Edge to Biopharmaceutical Industry
The future of mammalian cell culture is bright; thus, it is expanding. Many challenges remain, and new opportunities will emerge. This chapter...
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Comparative analysis of drug-salt-polymer interactions by experiment and molecular simulation improves biopharmaceutical performance
The propensity of poorly water-soluble drugs to aggregate at supersaturation impedes their bioavailability. Supersaturated amorphous...
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Cyclodextrin Based Host-Guest Inclusion Complex, an Approach to Enhancing the Physicochemical and Biopharmaceutical Application of Poorly Water-soluble Drugs
H ost-guest inclusion complexes have been extensively studied for drug delivery applications. The host molecule, typically cyclodextrin, creates a...
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The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life
Quality Control testing, coupled with the control over the manufacturing process, provides assurance of a biopharmaceutical’s identity, purity,...
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Models Used for Biopharmaceutical Evaluation of Nanoparticulate Drug Delivery System (NPDDS)
Nanoparticle drug delivery systems are engineered technologies that use nanoparticles for the targeted delivery and controlled release of therapeutic...
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An Empirical Analysis of Sacha Inchi (Plantae: Plukenetia volubilis L.) Seed Proteins and Their Applications in the Food and Biopharmaceutical Industries
Sacha Inchi ( Plukenetia volubilis L.) is a plant native in the Amazon rainforest in South America known for its edible seeds, which are rich in...
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Biopharmaceutical applications of Opuntia ficus-indica: bibliometric map, bioactivities and extraction techniques
Opuntia ficus - indica (OFI), widely recognized as prickly pear, is a native species from Mexico, being also widely distributed in many other...
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Spray dried mebendazole–loaded Soluplus-based polymeric micelles for improved biopharmaceutical attributes: in vitro and in vivo studies
The aim of this research was to investigate spray-dried mebendazole (MBZ)–loaded Soluplus-based polymeric micelles (MBZ@PMs) for improved solubility...
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Aliivibrio fischeri L-Asparaginase production by engineered Bacillus subtilis: a potential new biopharmaceutical
l -Asparaginase ( l -ASNase) is an enzyme applied in the treatment of lymphoid malignancies. However, an innovative l -ASNase with high yield and lower...
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Automated ion exchange chromatography screening combined with in silico multifactorial simulation for efficient method development and purification of biopharmaceutical targets
Bioprocess development of increasingly challenging therapeutics and vaccines requires a commensurate level of analytical innovation to deliver...
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Capillary Electrophoresis–Mass Spectrometry (CE-MS) by Sheath–Flow Nanospray Interface and Its Use in Biopharmaceutical Applications
Both capillary electrophoresis (CE) and mass spectrometry (MS) technologies are powerful analytical tools that have been used extensively in the...
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Ever-Present Threat of Adventitious Agent Contamination
If there is one serious patient safety concern that permeates every aspect of biopharmaceutical manufacturing, it is the ever-present threat of...