Search results for " DNA"
Article
Preclinical Evaluation of Product Related Impurities and Variants
Further, enzyme linked immunosorbent assay (ELISA) and PicoGreen assays were performed to measure levels of host cell proteins (HCPs) and host cell DNA (HCD), respectively.
Biological characte…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences
Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…
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Transformative Medicines Challenge FDA and Manufacturers
While systems that edit DNA are hard to reverse, changes from RNA-editing procedures disappear over time, which can be a plus, or a liability, depending on the situation. Although the long-term effect…
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Improvements in Protein A Chromatography
…tography provides high yield while providing up to 3 logs of host cell protein removal and 4 logs of DNA and virus removal. Resins are robust enough to be cleaned with caustic and re-used hundreds of…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Biopharmaceuticals are produced in cell cultures, and the final product is much more than a DNA sequence. These products are subject to post-translational modifications such as glycosylation, phosphor…
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Microbiological Testing: Time is of the Essence
The strong value proposition that RMMs offer, however, extends to the development of assays targeting other adventitious contaminants including viruses, mycoplasmas, residual DNA, and residual protein…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
…for cell treatment than ultraviolet light—widely known to induce mutagenic alterations in cellular DNA. Besides, the system combines the attractive properties of light as a controlled stimulus with a…
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Innovative Therapies Require Modern Manufacturing Systems
And it puts a hold on FDA consideration of new therapies that use genome-editing tools capable of modifying the DNA of human embryos.
Legislative action further made permanent the federal R&D tax …
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Selecting the Right Viral Clearance Technology
It is a gentle, effective method that works universally on small, large, enveloped, non-enveloped DNA and RNA viruses,” he observes.
A second inactivation/removal step is also frequently included,…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Important manufacturing CQAs related to protein integrity, homogeneity, presence of host-cell proteins, host-cell DNA, and/or substances released from process or package material, can be identified us…