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Highly purified charge variants of a proposed biosimilar to Omalizumab: impact on in vitro potency and stability under thermal stress
Biosimilars are highly complex and similar biological drugs are developed with different manufacturing processes which are not similar to originator...
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Modeling study of long-term stability of the monoclonal antibody infliximab and biosimilars using liquid-chromatography–tandem mass spectrometry and size-exclusion chromatography–multi-angle light scattering
Monoclonal antibodies (mAbs) represent a dynamic class of biopharmaceutical products, as evidenced by an increasing number of market authorizations...
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Differences in Proportion of N-acetyllactosamine and O-acetylated Sialic Acid Have No Significant Effect on the Pharmacokinetics and Biological Activity of Darbepoetin Alfa
Darbepoetin alfa is used to treat anemia in patients with chronic renal failure and is a therapeutic glycoprotein with five N-glycosylation sites and...
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Determination of functional similarity of biosimilar H9P2S from an investigational CHO clone with Adalimumab
Biosimilars, which are replicas of innovator pharmaceuticals, constitute the most significant share of biopharmaceutical products. These products are...
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Mechanical and surface properties of semifinished potato tuber exposed to UV-C radiation at varied operational parameters
The current study aimed at investigating the effect of certain operational parameters of UV-C radiator on the selected mechanical properties of...
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Comparative analytical profiling of bevacizumab biosimilars marketed in India: a national control laboratory study
In this study, analytical profiling of the bevacizumab (BVZ) biosimilars ( N = 3) approved in India were evaluated for charge heterogeneity,...
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Bioprocess Challenges in Purification of Therapeutic Protein Charge Variants
Biopharmaceuticals are complex therapeutic protein molecules produced in living cells and have been a major driving force for drug development in the...
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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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Regulatory Aspects and Barriers in Using Groundbreaking Technologies
New scientific discoveries and technological applications have been deeply influencing both the R&D and manufacturing of healthcare products,...
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Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
Regulatory compliance is essential for patient protection, and it applies both to Clinical as well as to Chemistry, Manufacturing & Controls (CMC)....
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Comparison of originator and biosimilar monoclonal antibodies using HRMS, Fc affinity chromatography, and 2D-HPLC
Due to the complex manufacturing process of therapeutic monoclonal antibodies, it is hardly possible to produce an identical copy of the original...
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Synthesis of Nanoparticles in Biofilms
Nanoparticles are of great interest in material science due to their characteristics, such as high surface area, biocompatibility, and unique optical...
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Advancing Human Progress as a Twenty-First-Century Science and Technology Pioneer
Since the emergence of the COVID-19 pandemic, society has been under tremendous stress. Geopolitical, environmental, and social forces have been...
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Seemingly Endless Biomolecular Structural Variants
Compared to chemical drugs, biopharmaceuticals have a highly complex, seemingly endless, biomolecular structural variant profile, especially due to...
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From Efficiency to Yield: Exploring Recent Advances in CHO Cell Line Development for Monoclonal Antibodies
The increasing demand for biosimilar monoclonal antibodies (mAbs) has prompted the development of stable high-producing cell lines while...
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Intellectual Property Rights in Biofertilizer Industry
IPR in biofertilizer is of great significance in today’s rapidly evolving agricultural demands. To improve soil fertility and plant development while...
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Intellectual Property Management in Nano-Biology Research
Intellectual Property (IP), creations of human mind having proprietary value and requiring rights and privileges for safeguarding against any...
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Zno nanoparticles: improving photosynthesis, shoot development, and phyllosphere microbiome composition in tea plants
BackgroundNanotechnology holds revolutionary potential in the field of agriculture, with zinc oxide nanoparticles (ZnO NPs) demonstrating advantages...
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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...