News Briefs

 

New Cell-Culturing System Introduced

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"Historically, autologous cell companies have been hampered by manufacturing technologies that use an outdated methodology for culturing cells, using plastic flasks.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."

Benchmarking Manufacturing Efficiency

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.

 

Pharmaceuticals Dominate Cleanroom Product Demand

Demand from pharmaceutical and other nonelectronic sectors will push U.S. demand for consumable products by nearly 6% per year to %1.6 billion by 2007, according to The Freedonia Group (Cleveland, Ohio; http://www.freedoniagroup.com. Demand for swabs and wipes, frequently sterilized via gamma irradiation or autoclaving, and individually packaged, will grow, the analysts say, with most wipes presaturated with isopropyl alcohol and deionized water to maintain sterility.

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.

Pharmaceutical Demand for Cleanroom Consumables, U.S.

(millions of dollars)

                             1992   1997   2002   2007   2012

Consumables         65       95       151     220     320

Production             50       74       117     175     260

Packaging              15       21       34       45       60

% of market           29.4   31.3    34.8    36.4    37.6

 

Motors in Medicine

Relatively seldom do the industrial equipment manufacturers behind the scenes in the pharmaceutical and medical device industry have an opportunity to directly impact patent care. But at the University College London in the U.K., motor stators, supplied free by ABB (www.abb.com) are helping children to walk again, according to experts based in ABB's U.K. offices.

The children being treated at the Royal National Orthopaedic Hospital, Stanmore, who have lost part of their leg bones after suffering from bone cancer, are being helped with a revolutionary new procedure that eliminates the need for years of painful surgery.

Because a large amount of bone has been lost, prosthesis is implanted in the patient's leg to support the remaining bone. As a child grows, the implant must be extended to keep pace with the skeletal growth. Previously, this involved further operations, often three or four a year over a five-year period, each bringing pain and inconvenience for the patient--and extra costs for the hospital.

The new procedure is non-invasive and involves placing a small magnetic rotor in the patient's leg. This is linked to the prosthetic implant by a gearbox and is turned by an external stator. To increase the length of the prosthesis, the patient's leg is placed inside the stator core.

When energized, the stator turns the rotor at 3,000 rpm, which drives the gearbox and extends the prosthesis by one millimeter every four minutes. A typical treatment will extend the prosthesis by four millimeters over the course of 16 minutes.

Quick and painless, the procedure can be completed in a clinic (outpatient basis), rather than as an admitted patient operation. Depending on a patient's growth rate, the implant is extended in small increments several times until the person is fully grown.

Mechanical expansion device for prosthetic implant saves growing children from repeated, invasive surgeries. The stator core supplied by ABB energizes a magnetic rotor inside the leg, extending the leg bone by some 4mm in 16 minutes.

 

Enzymatic Process Wins Product of Year Award

Frost & Sullivan, London (http://www.frost.com), has awarded its 2003 Product of the Year Award for Fine Chemicals to Germany's Degussa (http://www.degussa.com) for its single-step, enzymatic route to the L-amino acids used to make key pharmaceuticals and fine chemicals. Before this process was developed, a complex, energy-intensive chemical process route was required to make the synthetic amino acids.

Degussa scientists developed the new process with pioneering researchers from the University of Stuttgart and Caltech, using a tailored whole-cell biocatalyst that converts 5 monosubstituted hydantoins into either L- or D-amino acids in one pot with up to 100% chemical and optical yield.

 

New Contract Service Providers

 EaglePicher Pharmaceutical Services, Lenexa, Kan. (

http://www.eaglepicher.com), has established a new regulatory affairs support service to help pharmaceutical manufacturers manage regulatory compliance. The new service offers assistance in preparing quality-related documents such as chemistry, manufacturing and control (CMC) sections, scientific protocols, standard operating procedures and drug master files (DMFs).

 Xcellerx, LLC, a new contract process development and manufacturing company specializing in biomanufacturing has set up shop in Marlborough, Mass. The company (

http://www.xcellerex.com), has completed an initial round of private financing to license advanced manufacturing technology, acquire lab and manufacturing equipment and hire staff. The company's technology platform includes BioMax high-speed manufacturing process optimization capabilities, its modular FlexMax manufacturing platform, which, the company claims can reduce capital costs by up o 50%, as well as rapid glycoanalysis technology that the company recently acquired through an agreement with Procognia in the U.K.

 

Pharma Manufacturing Deals

 Genentech, Lonza in Custom Pact

Genentech, Inc., South San Francisco, Calif., and Lonza Group Ltd., Basel, Switzerland, have entered a long-term manufacturing agreement. Lonza Biologics will now make commercial quantities of the lymphoma treatment, Rituxan (Rituximab) for Genentech at Lonza's facility in Portsmouth, N.H.

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DFB Buys Largest Plant Cell Fermentation Facility

DFB Pharmaceuticals, Inc., Fort Worth, Tex. (http://www.dfb.com), has acquired Phyton, Inc., Ithaca, N.Y., a company that specializes in proprietary plant cell fermentation technology, to produce medicines without the need for plant harvesting, chemical synthesis, or use of mammalian, yeast or microbial organisms. The company expects the acquisition to expand its range of manufacturing services and broaden its drug development capability. "Phyton's plant cell fermentation technology enables the production of known and novel plant-derived complex small molecules, as well as biopharmaceuticals, from transgenic plant cells. The approach is environmentally beneficial, secure, rapidly scalable and cost effective, said Magnus Precht, Phyton general manager. He expects Phyton to become an integrated firm that will continue to develop and sell development and manufacturing services while developing its own drugs for DFB affiliate Healthpoint, Inc. based in Fort Worth.

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Honeywell to Automate New Biopharma Plant in Germany

Boehringer Ingelheim (http://www.boehringer-ingelheim.com) has awarded Honeywell Process Solutions (Phoenix; http://

www.acs.honeywell.com a contract to implement the Experion Process Knowledge System at its new biopharmaceutical plant in Biberach. The largest such plant in Europe, the Boehringer plant runs over 2,000 batch phases--significantly more than the 200 phases handled by a typical batch manufacturing installation. The new process-control system will encompass about 90 redundant controllers and 20,000 input/output points.

 

 

 

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