Tag: <span>contract research</span>

Induced Patent Infringement Breaks Free from Direct Infringement: The Implications for Bioprocessing

Infringement is the unauthorized copying of patented subject matter. Infringement can be either direct or indirect (e.g., induced or contributory), and the issue becomes complicated when the patented subject matter relates to methods. To illustrate, consider the fictional J.P. Jones, PhD, who has developed a burgeoning business in the bioinformatics field by dividing the practice of patented methods amongst several actors. Dr. Jones encouraged medical practitioners to augment their diagnostic resources by utilizing his for-profit laboratory to perform specific DNA analyses. The diagnostic methods collectively being followed by the clinicians and the independent laboratory were patented by another company, but in dividing performance of the method steps among the clinicians and the lab, Dr. Jones was able to ignore the patent rights by exploiting what has often been perceived as a loophole in US patent law. Under these circumstances, the patented protocols were not directly infringed. Consequently, Dr. Jones could not be held liable for inducing patent infringement. However, a September 2012 Appellate Court decision has changed things for Dr. Jones and his contract research organization (CRO.

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Biologics Production

biomedicine contract research cro intellectual property patent infringement patent law patents

Transient HEK293 Recombinant Protein Production Flow: The Replenishment of Protein Batches By Outsourcing to a Contract Research Organization

In order to unravel new protein activities and functions, we have expressed and purified a large number of human proteins. We have chosen to study secreted proteins and the extra-cellular domains of putative single transmembrane domain-containing proteins. In order to retain the natural protein characteristics as far as possible, we have used a mammalian expression system. Human embryonic kidney (HEK293) cells were chosen as they have been shown to possess a high protein-secretory potential. The secreted proteins were expressed with a carboxy-terminal tag and purified by affinity chromatography. Each protein was produced at a routine scale from 500 ml cell cultures, and the secreted protein was purified from the culture supernatant…

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Biologics Production Research

contract research outsourcing protein expression protein production pipeline purification recombinant proteins

Nucleic Acid Analysis of Viral Vectors: A Contract Research Organization’s Perspective

Currently, the U.S. Food and Drug Administration (FDA) recommends DNA sequencing for the structural characterization of gene transfer viral vectors in investigational New Drug Applications (INDs). While FDA provides guidelines on what should be sequenced in regard to these vectors, it provides little insight — beyond GLP/GMP (GxP) guidelines — into how the finalized sequence data should be obtained. There is presently no provision for determining which sequencing methodology (or methodologies) is most appropriate for obtaining a completed sequence characterization for each of the different vector classes, and there is no standard that outlines what DNA sequencing-specific criteria the data and data collection processes should meet in order to guarantee that the sequence is 99.99% accurate…

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Nucleic Acids Research Uncategorized Viral Vectors

characterization contract research DNA quality sequencing shotgun sequencing standards