Search results for " DNA" in Articles / App Notes
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
… editing, including an assay qualification process that would expand the capability to make targeted DNA changes. The NIST genome editing consortium includes a range of industry members and seeks exp…
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Ensuring Viral Safety of Viral Vaccines and Vectors
This method allows simultaneous sequencing of millions of DNA or RNA fragments and requires no prior knowledge of potential virus contaminants (29).
Remove or inactivate viral contaminants downstr…
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A Look into the Future of Biopharmaceutical Quality
…r the past 50 years, the industry has grown, especially due to advances in areas such as recombinant DNA and hybridoma technology, and more recently gene and cell therapies. As these advancements hav…
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Putting Viral Clearance Capabilities to the Test
The viruses tested should include both enveloped and non-enveloped viruses, and both RNA and DNA viruses with different physical and chemical properties.” He also notes that the studies should be cond…
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Modern Manufacturing Key to More Effective Vaccines
This coincides with efforts to shift from egg-based to cell-based and recombinant DNA production technologies. In commenting on the effectiveness of this year’s flu vaccine, Gottlieb noted that produc…
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Impurity Testing of Biologic Drug Products
Process-related impurities and residuals such as Protein A can be detected and quantified with ELISA assays, whereas host cell residual DNA can be quantified via quantitative polymerase chain reaction…
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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…