News Briefs

Isolagen, Inc., Houston (http://www.isolagen.com), has developed a new cell culturing and manufacturing system to develop and commercialize autologous cellular therapy for hard and soft tissue regeneration. In these therapies, a patient's own cells are extracted, reproduced and then reintroduced for specific cosmetic and medical applications.

To develop this technology, Isolagen worked closely with Applikon Biotechnology's (http://www.applikon.com) process for using sound waves to separate cells from culture medium in bioreactors. A new twist to Applikon's system automates cell harvesting in a closed-loop sterile system, rather than using traditional centrifuge technology. As a result, production costs should be significant lower as the company moves toward mass production.

"Historically, autologous cell companies have been hampered by manufacturing technologies that use an outdated methodology for culturing cells, using plastic flasks. This method is labor intensive and slow, and embedded with high costs, says Isolagen CEO Michael Macaluso. "We have automated our system to streamline our process, and have collaborated under a joint intellectual property agreement that allows Isolagen to patent its manufacturing system improvements beyond Applikon's existing patents."

To help pharmaceutical manufacturing executives benchmark production efficiency, the consulting firm, Best Practices, LLC (Chapel Hill, N.C.; http://www3.best-in-class.com) recently looked at what such leading manufacturers such as Aventis, Pfizer, Lilly, AstraZeneca, Wyeth, Bayer, DSM, Patheon and aaiPharma are doing right, and what they can teach others in such areas as staffing, maintenance and automation.

The study found that capacity utilization was a key driver in pharmaceutical manufacturing cost management and production efficiency. At any manufacturing facility, too much variety in product type can lead to underutilized equipment and diluted performance. In general, the study found, the most efficient manufacturers dedicated single facilities to either injectables or solid dosage forms. Increasing the number of shifts for bulk production and packaging increased capacity utilization, the study found , where, with injectables, dedicating single facilities to a specific task improved efficiency.

With staffing, the study found, "best practices' dictated an optimum ratio of about 10 employees per manager, although, reflecting complexity, the ratio of supervisors for injectables production tended to be higher.

Most respondents reported only average degrees of automation in their plants, the study says, blaming regulatory compliance pressures for slower adoption. However, facilities that have embraced automation, are enjoying substantial benefits, with better maintenance cost, headcount and overtime performance when compared to their peers.

As pharmaceutical manufacturers turn to mini-environments to seal off aseptic packaging and other operations, demand for apparel, cleaning products and filters will also grow, the study found. For example, while isolators require fixed gloves, attached to the enclosure, concerns about contamination also require that workers wear conventional cleanroom gloves within the fixed gloves. The impact of minienvironments will also translate into demand for relevant aseptic packaging. Bioprocessing and food applications will also emerge as key growth areas, Freedonia predicts.