May 2007 - Pharmaceutical Technology

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PharmTech Europe

May 2007

Pharmaceutical Technology



Company Notes
"SOCMA wants to commend DHS for their hard work in promulgating these regulations," said Joe Acker, the group's president, in a prepared statement. "We support the phased-in approach to the rules, but would like to have seen more time given for companies to perform their SVA, especially small companies with limited resources. The shortened timeframe will make it extremely difficult for companies to evaluate the new rules and then perform the appropriate tasks in the prescribed timeframe required by the rule."

SOCMA pointed out issues relating to the type of facilities able to conduct alternative SVAs. "DHS's decision to limit alternative SVAs to only Tier 4 facilities is disappointing," said Acker. "Facilities that have taken the proper action over the last five years, which include all of SOCMA's member facilities, will need to unnecessarily reconduct risk assessments, even though nothing has changed in their overall risk profiles."

Under the rule, DHS places facilities in one of four risk-based tiers, ranging from Tier 1, which contains the highest-risk covered facilities, to Tier 4, which contains the lowest-risk covered facilities.

SOCMA also raised concerns about the possible omission of certain risk-reduction measures in DHS guidance. "SOCMA understands and supports DHS's intent to use guidance for assisting facilities in meeting the new security standards," said Acker. "SOCMA expects that many risk-reduction measures that could be taken by facilities will not be captured in the guidance. These risk-reduction measures should be given the same consideration as measures found in the DHS guidance materials."

-Patricia Van Arnum

MANUFACTURING EXPANSION

GlaxoSmithKline Plans Investment in Irish Manufacturing Facility

London (Mar. 29)—GlaxoSmithKline (GSK, http://www.gsk.com/) plans to invest EUR 250 million ($334 million) in its production site at Currabinny, Ireland over the next five years, according to a release issued by the Irish Development Agency (IDA Ireland, Dublin, http://www.idaireland.com/).

The investment will support production for lapatinib, the active ingredient in GSK's "Tykerb," a new oral treatment for advanced breast cancer. In March 2007, the US Food and Drug Administration (Rockville, MD, http://www.fda.gov/) approved Tykerb in combination with "Xeloda" (capecitabine), an anticancer treatment from Roche (Basel, Switzerland, http://www.roche.com/), for treating advanced or metastatic breast cancer.

"We are delighted to have been chosen as the production site for the Tykerb active ingredient following years of committed research and development work by GSK employees around the world," said Finbar Whyte, site director at GSK Cork.

GSK Cork is a strategic global new product introduction site within GSK that manufactures the active ingredients of medicinal compounds. The Currabinny site was established in 1975 and employs more than 600 people. The new investment will create as many as 150 new high-level positions, according to IDA Ireland, an Irish government agency responsible for securing new investment from overseas in the manufacturing and internationally traded services sectors.

-Patricia Van Arnum

DRUG DELIVERY

Advances and concerns regarding nanotechnology presented at conference


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