Cell substrates are used in various stages of viral vaccine manufacturing, as in the isolation, selection, and propagation of the virus seed or virus vector stock, as well as for the amplification of the virus to produce the final vaccine product. The various stages of cell substrate use, including cell banking, are shown in a generic manufacturing scheme in Figure 1. Traditionally, viral vaccines have been produced in animal tissues, primary cell cultures, and cell lines that either have a finite life span, such as normal diploid cells, or a theoretically infinite life span, as achieved with continuous or immortalized neoplastic cells. The cell substrates used in viral vaccines currently licensed in the US are listed in Table 1…
Tag: <span>testing</span>
Recombinant DNA-transduced cellular products encounter the product development and regulatory issues of both gene therapy and cellular therapy products. The characterization of recombinant DNA-transduced cellular products remains highly challenging for both sponsors and regulatory agencies. The regulatory concerns and product testing for such cellular products are similar to those for all biologicals. These concerns include the demonstration of product safety, identity, purity, and potency; the control of the manufacturing process to ensure the consistency of product manufacturing under a proper quality control program; and the demonstration of reproducibility and consistency of product lots by means of defined product lot release testing criteria…
Psoriasis is a chronic, inflammatory disease of the skin that is estimated to affect 2-3% of the U.S. population. The estimated annual outlay for treating the disease has ranged from $1.6 billion to $3.2 billion, and the cost to individuals with the disease is far higher than the monetary costs. Psoriasis is characterized by excessive keratinocyte proliferation, leading to a significant thickening of the epidermis, expansion of epidermal rete pegs into papillary dermal space and abnormalities in the differentiation process. Clinically, one sees red, raised, scaly lesions that can occur over any part of the body. The etiology of the disease is complex and not well understood. T-cells are almost certainly involved in the initiation and maintenance of psoriatic lesions. Although the triggering event is immunological, alterations in keratinocyte function also appear to be important to the overall pathophysiology…
The Vmax™ technique has been used extensively to estimate filter area requirements for normal flow filtration (NFF) processes in biopharmaceutical applications. The benefits that this technique presents over conventional flow decay methods are the speed of testing, reduced volume requirements for evaluation, and competitive testing of varying filter types/sizes — all of which present an optimized filter screening strategy and preliminary estimate of optimized filter size requirements. Filter size or filtration area requirements derived using the Vmax technique consist of contributions from both capacity and flow-time aspects of the filtration process. This article examines the relative contributions of these terms to overall filter sizing vis-à-vis the ease of fluid filterability…
Although biological products are being licensed at a fairly steady pace, the cost to develop each product can be incredibly high, and far too many products with very little chance of success are entering clinical trials. The cost of developing a biological product is now estimated to be as high as $1.7 billion. This is truly a staggering figure that would seem to prevent all but the strongest company from attempting such a gamble. However, this number includes the cost of all the products that didn’t make it through pre-clinical development, or which entered clinical trials and failed for any number of reasons…
The United States Pharmacopeia (USP) is a 184-year-old organization that has been in the forefront of technology since its inception. From publishing a manual about how to prepare therapeutic potions, USP has evolved into a compendium of standards and information on manufactured pharmaceutical products, with more than 4,000 monographs covering drug substances and biologics, and their dosage forms, excipients, and nutritional supplements. It is not surprising that the USP initiative in cell and gene therapy and tissue engineering has closely followed the emergence of these technologies…