Cardinal makes first GMP antibody batch
destined for human clinical trials, using a cell line that was made
with its patented GPEx (Gene Product Expression) technology.
The antibody will be used to support a clinical trial by the Ludwig Institute for Cancer Research (LICR) aimed at treating epithelial tumours.
Paul Weiss, president of Cardinal Health's biopharmaceutical development services centre in the US, said: "completion of our first current Good Manufacturing Practice batch from a GPEx cell line was the next step in the execution of our integrated offering that allows us to assist companies in getting their biopharmaceutical products into clinical development more rapidly."
The GPEx technology enables rapid genetic engineering of stable, high- expressing, mammalian cell lines. These cell lines are used to produce recombinant proteins, such as monoclonal antibodies. In addition to enabling rapid cell line development, the GPEx technology is suited for both pilot/clinical and commercial-scale production of antibodies and other therapeutic recombinant proteins.
Through insertion of multiple copies of the target genes, GPEx can generate, in as little as half the time required using traditional methods, stable cell lines with significantly higher levels of expression than those cell lines generated by other methods.
Cardinal acquired the forerunner of the GPEx technology when it bought out Gala Biotech in 2003 for $15.5 million.
Eric Hoffman, director of the LICR Office of Clinical Trials Management, said the attraction of the technology was the ability to have the cell line expressing this antibody engineered with the GPEx technology and then moved it directly into process development followed by cGMP manufacturing of the antibody, all at the same site.
Cardinal is also carrying out aseptic filling of the antibody into vials, he noted. Weiss said that both of Cardinal's cGMP suites are presently occupied with manufacturing projects involving GPEx cell lines.
Last month, Cardinal signed an agreement with PSMA Development Company (PDC) to use GPEx to produce a monoclonal antibody that targets prostate specific membrane antigen (PSMA), a biological marker found on the surface of prostate cancer cells. It also has an agreement in place with Cambridge Antibody Technology.
