Cardinal flies into new territory

SOMERSET, N.J. – Cardinal Health announced in early January a collaboration with Centocor Inc., under which Cardinal will develop for Centocor cell lines that express undisclosed monoclonal antibodies. The agreement helps to cement Cardinal's efforts to offer a broad menu of services for biopharmaceuticals, from drug discovery and manufacture through packaging and distribution.

The agreement with Centocor, says Paul Weiss, president of Cardinal's biopharmaceutical development services center, formerly known as Gala Biotech, enables Centocor to "test drive the technology" of Cardinal's Gene Product Expression (GPEx) cell line engineering technology and "exercise the option to commercialize the product" if desired. Cardinal will use GPEx to generate monoclonal antibodies, and Centocor, says Weiss, "will take the deliverable and evaluate it within their own groups," with the possibility of licensing the cell lines for manufacture at Centocor. No financial details of the deal were released.

While acknowledging that Centocor is "quite aggressive" in pursuing various platforms for producing monoclonal antibodies, Weiss describes GPEx as "very fast to create stable high-expressing mammalian cell lines" in a system that is "uniquely qualified to produce cell lines that produce antibodies." GPEx inserts multiple gene copies into cells to maximize genetic potential for creating human proteins and antibodies; the technique is based on technology developed at theUniversityofWisconsin, says Weiss.

Cardinal's engineering approach "is just one of many," says Alan Louie, research director at Health Industry Insights, an IDC company, and companies like Centocor should try varied techniques for producing optimal biopharmaceuticals. Louie downplays the importance of speed in creating monoclonal antibodies because quality materials for clinical trials are more important, but he believes mammalian cell lines, such as those produced under the Cardinal approach, "are clearly the future of biologics because the products behave better in the body" than biopharmaceuticals generated with other methods.

Centocor's collaborations for exploring therapeutic protein production have included agreements with Biolex, which uses a plant-based system, and GlycoFi, which uses a yeast-based technology. Centocor, according to a spokesperson, looks forward to collaboration with Cardinal but declined to comment for this article. Centocor, a wholly owned subsidiary of Johnson & Johnson, focuses on developing, producing, and commercializing biologic therapies, such as Remicade, a monoclonal antibody that treats diverse diseases like rheumatoid arthritis, Crohn's disease, and ulcerative colitis.

Louie finds the Centocor announcement interesting because Cardinal, which he says holds "a self-sustaining strong position" as a medical product distributor, is expanding its support of drug discovery. He sees collaborations like the Centocor agreement as an inroad for increasing contract manufacturing and formulation work, where Gala's expertise, which he calls "a sharply defined small piece" of Cardinal, extends the company's capabilities into biological products in "a logical progression… to be able to provide a more comprehensive service offering." Cardinal also signed a cell line engineering collaboration with Cambridge Antibody Technology in May 2005.

Weiss says that, though his division is a wholly owned subsidiary that employs only 55 or 60 of Cardinal's 55,000 employees worldwide, it provides crucial technology that make Cardinal "an integrated provider in an inherently difficult area." Packaging and distribution options for biopharmaceuticals must be performed under FDA guidelines, he says, but Cardinal has "unique solutions for biotech products, most of which are proteins, most of which need to be frozen or refrigerated."