Radiopharmaceutical supplier Tyco Healthcare/Mallinckrodt of St. Louis emphasized improvements the company has been making in the manufacturing process for its technetium-99m generators at the Society of Nuclear Medicine (SNM) meeting. The company had suspended shipments of the generators for five months due to quality-control issues.
In November 2005 Mallinckrodt issued a voluntary recall of its Ultra-TechneKow DTE technetium-99m generators as a result of issues arising from a routine sterility assurance process revalidation in the generator production line at its plant in Maryland Heights, MO. After the five-month interruption, generator shipments resumed April 7. In the meantime, Mallinckrodt's customers were supplied by competitor Bristol-Myers Squibb Medical Imaging of North Billerica, MA.
Mallinckrodt is now working to get its technetium-99m customers back, and some 70% of them have returned, according to Jackie Groff, group marketing manager for nuclear medicine. The company is also making a number of improvements to its manufacturing process to reduce the likelihood of future interruptions.
For example, Mallinckrodt is installing a second generator production line at the Maryland Heights facility so it can take one line down without interrupting supply. The company has also addressed the issues in the generator line that resulted in November's voluntary recall, and the line has made 38 technetium-99m runs since it came back online with no major issues.
In its SNM booth, Mallinckrodt highlighted the complexity involved in delivering radioisotopes to customers on a daily basis. In the case of technetium-99m, the radioisotope begins its journey at a nuclear reactor in Peten, Netherlands, which produces molybdenum, a technetium precursor, in a six-day process.
The radioisotope's short half-life requires it to then be shipped on one of four weekly flights from the Netherlands to Mallinckrodt's manufacturing facility, where it arrives by 10 p.m. By 5 a.m. the molybdenum has been converted into technetium-99m generators that are being distributed to customers across the U.S. The total process, from leaving Peten to a customer's doorstep, takes less than 36 hours, Groff said.
On the product side, Mallinckrodt promoted its line of radiopharmaceuticals, such as OctreoScan for primary and metastatic neuroendocrine tumors, TechneScan MAG3 for kidney imaging, MyoView, technetium-based heart imaging agent that the company co-markets with GE Healthcare of Chalfont St. Giles, U.K., and thallous chloride thallium-201.
Mallinckrodt is bringing a new cyclotron online for thallium production, which is expected to be ready by the end of 2006. The cyclotron will bring to six the number in Mallinckrodt's portfolio, according to Groff, with another new system just added in 2005.
The company also discussed its educational efforts that are under way to help nuclear medicine technologists gain a better understanding of patient anatomy to help them deal with the growing number of PET/CT and SPECT/CT studies being conducted.
By AuntMinnie.com staff writers
June 7, 2006
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