Tag: <span>DNA</span>

Five Insurance Tips for Biotechnology Companies Facing Product Recalls or Liability Claims

Biotechnology companies — those that research and manufacture products through the use of biological techniques such as genetic engineering and the development of specialized strains of biological substances — constitute an increasing segment of the US economy. These companies might: (a) create a new type of insect- or drought-resistant corn by the modification of genes; (b) alter naturally occurring enzymes to aid in manufacturing or to help produce foods; (c) use recombinant DNA to create medicines that are remarkably effective in curing or treating disease; or (d) use any of a number of other techniques to create beneficial and potentially lucrative products. Just like other industries, biotechnology groups can be faced with recalls of their products, either voluntary or government-mandated, or claims that their products have caused bodily injury or property damage to their customers. Because biopharmaceuticals are produced by — or extracted from — a biological source, the chances of a product recall are higher than that of a synthesized drug. In April 2012, a report by GBI Research, an independent research firm, concluded that biologics were involved in more recalls, voluntary or mandatory, than drugs from other sources for the four-year period from 2007 through 2010…

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Biologics Production

biological product recall biological substances biologics biopharmaceutical recall biotechnology biotechnology insurance DNA gene engineering liability issues recombinant dna therapeutics

Risk Assessment of Residual Genomic DNA in Therapeutic Proteins Using Gene Copy Number Application

Therapeutic proteins manufactured in cellular systems contain residual DNA derived from host cell substrates used in production. Risk assessment of the residual host cell DNA is necessary, as some of these DNA sequences may be potentially infectious or oncogenic. Oncogenic potential lies in transmission of the activated oncogenes to subjects receiving the product, thereby inducing oncogenic events. Therefore, it becomes essential for drug manufacturers to show clearance of genomic DNA (oncogenic sequences as well) throughout production processes and to confirm low levels of residual DNA in the final drug substance. This study attempted to estimate the oncogenes in the total residual DNA using a highly sensitive, specific, and robust method—quantitative polymerase chain reaction (qPCR). Routinely, total residual DNA is estimated using either the 18S ribosomal (r)DNA gene or Alu equivalent multicopy gene sequence as qPCR targets. We have determined the copy numbers of these qPCR targets along with the oncogene (Ras gene) and housekeeping genes (ACTB and GAPDH) and established a ratio of their presence in protein samples. Another objective of the study was to estimate the level of oncogenes from several in-process step samples in the manufacturing and purification process and check the clearance of total residual DNA including oncogenes. Upon quantification, the proportions of oncogenes present were one tenth of the quantified residual DNA levels (Ras gene:18S RNA) in the purification stage samples, providing information that the therapeutic protein product was safe from the presence of oncogenes in residual DNA by a factor of ten…

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Biologics Production

biologics biopharmaceuticals DNA gene copy number oncogenic sequences purification process qpcr residual genomic dna risk assessments therapeutic 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