Pharmaceutical manufacturing: news in brief

In-PharmaTechnologist.com brings you a selection of recent headlines from around the pharmaceutical manufacturing industry.

Penn State and Agarigen have received $2.2m in initial funding under the Accelerated Manufacture of Pharmaceuticals programme for the rapid production of vaccines and other therapeutic proteins in genetically modified mushrooms.

Awarded by the US Defence Advanced Research Projects Agency (DARPA), the grant could be worth up to $5.9m.

"Our immediate research goals are to maximise the level of expression of various biopharmaceuticals and to devise efficient and economical methods for their extraction and purification from mushroom tissue," Penn State plant pathology professor Peter Romaine said.

By the end of the second year of the contract, the researchers are expected to demonstrate an ability to produce vaccines or other biological drugs within 12 weeks.

In a pending third year, the researchers are expected to show they can execute a full-scale manufacturing effort and produce three million doses of a drug in 12 weeks.

Labopharm has received a written response from the US Food and Drug Administration (FDA) after appealing the agency's approvable letter for its once-daily tramadol formulation for the treatment of moderate to severe pain.

The FDA has decided to not overturn the decision in the agency's approvable letter of May this year.

Labopharm plans to appeal the matter.

The company received a second approvable letter from the FDA for its once-daily formulation of tramadol in May this year despite submitting additional efficacy and safety data after a first approvable letter was received by the company in September last year.

In statements, the company said it "firmly believes it has met the statutory standards for approval of its once-daily tramadol formulation . . . Labopharm strongly believes that it has provided the FDA with more than adequate evidence of the efficacy and safety of its once-daily formulation of tramadol".

Dow Polyglycols and Surfactants has announced an increase of Euro 100/MT for grades Carbowax industrial liquid PEG 200E, PEG 300E, PEG 400E, and PEG 600E in Europe, India, Middle East and Africa.

The move is a result of "unprecedented" increases in raw material costs, which have "risen faster and higher than predicted", Dow product marketing manager John Davidson said.

Carbowax and Carbowax Sentry Polyethylene Glycols (PEGs) and Methoxypolyethylene Glycols (MPEGs) are a family of water soluble linear polymers formed by the addition reaction of ethylene oxide.

The changes come into effect as of December 1.

Advion BioServices is expanding its capacity with the acquisition of two Applied BioSystems/MDS Sciex API 5000 mass spectrometers and Waters Acquity UPLC capability.

The company, the bioanalytical services division of Advion BioSciences, has also hired 17 employees since relocating to its new laboratory facility in April this year.

The addition of these API 5000 mass spectrometers brings the number of triple quadrupole mass spectrometers within Advion's bioanalytical laboratory in Ithaca, New York, to 24, making it one of the largest bioanalytical contract laboratories in the world.

The acquisition of UPLC by Advion provides a wider range of liquid chromatography capabilities to offer its customers.

Novartis Pharmaceuticals Canada has received the 2007 Belleau-Nickerson Award for Gleevec (imatinib).

Presented at the Prix Galien gala ceremony in Montreal last week, the award recognises the therapeutic, social and economic contribution of a drug product marketed in the past 10 years.

Gleevec was the first cancer treatment to be developed based on a better understanding of how cancer works and acts by selectively targeting disease-specific cellular abnormalities.

The drug is currently indicated for the treatment of chronic myeloid leukaemia and is approved for treatment of gastro-intestinal stromal tumours and Philadelphia-positive Acute Lymphoblastic Leukaemia.