Search results for " DNA" in Articles / App Notes

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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 …

Article 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,…

Article 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…

Article Ensuring the Quality of Biologicals
Biologicals are those products derived from biological sources such as tissues and cell extracts, fermentation using micro-organisms, plasma, plants, or those produced by recombinant DNA technology. T…

Article Continuous Manufacturing: A Changing Processing Paradigm
Even so, because perfusion involves continuously introducing fresh media, there is less accumulation of toxic waste products, degraded DNA, and other debris than is associated with products that remai…

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