DSM's biomanufacturing facility in Groningen, the Netherlands, will increasingly focus on supporting projects incorporating
the PER.C6 system, especially manufacturing Phase I/II clinical supplies and pilot-scale manufacturing. DSM officials expect
that they should have sufficient capacity at Groningen to support the PER.C6 projects as well as projects incorporating other
systems. No capacity expansion is planned. The companies are in the process of negotiating arrangements with other CMOs to
act as commercial manufacturing partners for products using the PER.C6 system.
DSM and Crucell will work together to expand the number of licenses for PER.C6 in the production of recombinant proteins and
monoclonal antibodies, with a particular focus on North America. Crucell has exclusive rights to the system for the vaccine
and gene therapy markets, and has been actively signing new agreements for viral production in recent months.
The focus on the PER.C6 venture with Crucell appears to reflect a decision at DSM that improvements in process yields will
ultimately trump the need for more production capacity. In announcing the closing of the Montreal facility, the company said,
"In the field of biopharmaceuticals the development of cell line technology, the software, will potentially be of more impact
than the installment of new contract manufacturing capacity, the hardware."
DSM's position closely mirrors that of Dowpharma (Midland, MI), a business unit of Dow Chemical, which decided last year to
close its biomanufacturing operations in Smithfield, RI, and focus its efforts on its PFenex microbial expression technology.
Just days after the DSM-Crucell announcement, Dowpharma announced that Cambrex Bio Science (Baltimore, MD) had agreed to become
its first manufacturing partner for the PFenex technology. The two companies will develop a standardized technology transfer
package to facilitate adoption by contract manufacturing clients.
Cardinal Health (Somerset, NJ) has adopted a similar position as it promotes its GPEx cell line engineering technology. GPEx
was developed by Gala Design (Middleton, WI), which Cardinal Health acquired in 2002. In early January, the company signed
an agreement with Centocor (Horsham, PA) to engineer cell lines to express undisclosed Centocor monoclonal antibodies. Cardinal
Health has development scale capabilities but no large-scale commercial bioreactors.
Biomanufacturing experts don't necessarily agree that proprietary expression systems provide a big advantage over what can
be achieved with well-designed processes incorporating public domain hosts like CHO cells and E coli. This is especially true when considering the licensing fees that will have to be paid to use proprietary systems. However,
biomanufacturers clearly believe they can make a strong case that their proprietary systems can deliver better yields and
faster development cycles. Perhaps more important, the expression technology strategy allows companies to stay in the game
without risking large amounts of capital for new bioreactor capacity.
Jim Miller is president of PharmSource Information Services, Inc.,
703.914.1203, Fax: 703.914.1205, Jim.Miller@pharmsource.com
|
