With the continued progress of adenoviral vectors in gene therapy studies it is increasingly evident that a more formalized approach to the characterization and analysis of these viral vectors is urgently needed. Today, adenoviral vectors are beginning to be considered “well characterized biologics,” as shown by numerous publications describing sophisticated analytical approaches for recombinant adenovirus product candidates. Because the analytical definitions of adenoviral vectors currently lack comparison to a common standard, the problem for regulatory agencies is how to objectively evaluate safety in relation to the administered dose. This well-recognized need for an adenovirus standard has been addressed by a consortium of representatives from regulatory agencies, industry, and academic organizations — the Adenoviral Reference Material (ARM) Working Group. Its work has come to fruition in the recent public availability of the ARM, a purified wild type 5 adenovirus. Many aspects of the history, production, and characterization of the ARM have been published in detail…
Tag: <span>safety</span>
Tissue engineering is an emerging area of biotechnology that will provide replacement tissues for patients, as well as complex, functional biological systems for research and testing in the pharmaceutical industry. A new research area of tissue engineering is the investigation of how living cells interact with and respond to synthetic biomaterial surfaces. The clinical developments that underlie that research include a number of novel tissue-engineered medical products (TEMPs)…
Electron microscopy (EM) provides data for viral clearance studies, information on the presence and quantitation of endogenous retroviruses, and the detection and characterization of other potential contaminants. The technique is favored in this field because it is simple, reliable, and can give reliable quantitation for risk assessments. This article describes the main EM techniques currently used for testing cell cultures, culture supernatants, and bulk harvests. It also includes an in-depth description of a thin sectioning technique used to estimate virus titre in culture supernatants and bulk harvests…
As product development proceeds in the field of cellular therapies, adequate product characterization remains a challenge for both IND Sponsors and FDA/CBER. Cellular therapy products are not considered to be well-defined products, and therefore the control and characterization of each stage of the production process helps to ensure product safety and consistency. Product characterization of cellular products includes demonstration of safety, plus determination of identity, purity, potency, and product stability. Development of appropriate specifications for each of these parameters is necessary for lot release, and also provides an important database of knowledge for addressing regulatory issues, such as lot-to-lot consistency and potential issues with product comparability, should the manufacturing process, or other aspects of product development, change over time…
The baculovirus expression system promises to revolutionize the production of recombinant proteins for use as clinical products. The technology is robust, efficient, and low-cost when compared to other cell based systems. The technique may also present an advantage in producing safer products versus the equivalent materials made with mammalian cells. Proteins can be produced in insect cells without animal supplements such as fetal calf serum. In the current climate of concerns over Bovine Spongiform Encephalopathies, and bovine viral risks, this method offers a significant safety, as well as cost advantage, over other production methods…