Search results for " cell"
Article
Trends in Single-use Bioreactors
In addition, there are improved control systems that allow multiple unit operation and sophisticated feed strategies improving cell yield and increasing titer with single-use bioreactors. Ergonomic fe…
Article
Maximum Output Starts with Optimized Upstream Processing
…clonal antibodies (mAbs) to advanced multispecifics, antibody-drug conjugates, viral oncolytics, and cell, gene, and gene-editing therapies—was occurring worldwide before the emergence of the COVID-1…
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Preclinical Evaluation of Product Related Impurities and Variants
This may be attributed to the complexities related to the use of cell lines, media formulation, and other bioprocessing steps that are prone to variability to varying degrees (4).
The inherent …
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Examples include cell-culture, synthetic DNA, chimeric antigen, and recombinant protein nanoparticle vaccine technologies.
Egg-vaccine technology limitations
Traditional vaccine manufactu…
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Quality by design for biotechnology products—part 1
In some cases, an IgG1 isotype is ideal for cell killing, whereas IgG2 is a favored isotype for eliminating the effector function of an antibody on target binding. For further enhancement of cell kill…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Blincyto targets cell surface proteins CD19 and CD3 simultaneously, helping to put T cells within reach of the targeted cancer cell with the goal of allowing the T cells to inject toxins into cancer c…
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Scaling Up Novel Therapies
Developers are exploring how these platforms might be used in novel therapies such as cell and gene therapies. Although these treatments are in early stages of development, gene therapy has already be…
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Putting Viral Clearance Capabilities to the Test
Raw materials and cell substrates must be characterized using molecular, in-vitro, and in-vivo testing strategies, she says, and cell banks and end-of-production cells are tested to identify species o…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
By Jill Wechsler
Amid mounting excitement over remarkable efficacy rates for new genetically modified cellular therapies, regulators and manufacturers alike face continuing challeng…