CEL-SCI Secures Manufacturing Facility for Multikine C...(as Multikine produced in the same manufa...),Health

Date:8/19/2007

as Multikine produced in the same manufacturing facility for Phase III clinical trials and the sale of the product because this arrangement helps to ensure that the drug lots used to conduct the clinical trials will be consistent with those that will be marketed subsequent to approval.

Although some biotech companies outsource their manufacturing, this can be risky with biologics because they require intense manufacturing and process control. With biologic products a minor change in manufacturing and process control can result in a major change in the final product. Good and consistent manufacturing and process control is critical and is best assured if the product is manufactured and controlled in the manufacturer's own facility by their own specially trained personnel. In fact, there have been many situations in which companies had to repeat their Phase III trials or perform an additional clinical bridging study to address regulatory concerns resulting from outsourced manufacturing. This has led to enormous costs and lengthy delays in getting biotech drugs to market. In addition, using a contract manufacturer ties the company's approval to the manufacturing facility of the contractor, further reducing the level of control by the company.

Geert Kersten, Chief Executive Officer of CEL-SCI said, "Manufacturing biologics is such an expensive endeavor that most biotech companies partner with larger companies, and in the process give up their marketing rights. The funding with BioRealty, Inc. will allow us to keep the marketing rights, thereby giving our shareholders the greatest value creation. Now that the significant hurdle of manufacturing has been tackled, we are able to focus on getting Multikine through Phase III, and ultimately to patients."

Stan Wendzel, Managing Director of BioRealty, Inc. said, "After having completed the due diligence on both CEL-SCI and its Multikine product, we recognized that CEL-SCI may fundamentally change the standard
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SOURCE CEL-SCI Corporation Copyright©2007 PR Newswire.

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