Xcellerex, Inc. and Gallus BioPharmaceuticals,
LLC have announced that they have entered into a collaboration that quickly
provides Gallus with expanded cGMP biomanufacturing capacity by leveraging the key
advantages of the turnkey Xcellerex FlexFactory(R) GMP manufacturing platform
suite. The strategic collaboration will provide Gallus with world-class,
scalable, flexible and cost-efficient manufacturing and laboratory technology
to expand its contract manufacturing business. In addition this partnership
will provide Xcellerex’s customers unprecedented access to a commercial, FDA approved,
biomanufacturing facility.
Under the agreement, Gallus is acquiring several Xcellerex bioproduction
systems for new suites and laboratories at its existing manufacturing facility.
Along with single-use XDR bioreactors to quickly expand capabilities in an
existing commercial manufacturing suite, Gallus is acquiring small scale 10L
bioreactors for its expanded development laboratory and a turnkey FlexFactory
cGMP manufacturing line with XDR single-use bioreactors up to 2000 liter scale
for clinical supply. Such rapid capacity expansion with single-use technology
not only enables Gallus to offer more services and options to its customers,
but also augments Gallus’ existing, multi-suite commercial capacity with novel,
proven single-use Xcellerex bioreactors. Through the collaboration, Xcellerex
and Gallus will provide their customers with access to Gallus’ established biomanufacturing
expertise in a world-class facility that has been inspected and approved by all
major regulatory authorities.
“Gallus has a unique contract manufacturing business
model that enables us to respond to clients’ changing capacity needs quickly,
and achieve rapid, high quality production at a competitive price,” said Mark
Bamforth, President and CEO of Gallus. “The partnership with Xcellerex
allows us to leverage their single-use biomanufacturing platform. This is a
strategic investment that rapidly provides us with additional manufacturing
capacity and scale-up capabilities to deliver development, clinical and
commercial products and services. The first manufacturing suite will be in
place by the end of 2011. Additional suites can be added to meet specific
customer needs, within the existing facility at our site in St. Louis.” Gallus is a contract
biologics manufacturer that was established in 2010 and recently acquired an
existing Johnson & Johnson/Centocor manufacturing facility in St. Louis, Missouri.
The facility is currently producing two commercial products that are approved globally.
The company’s business model includes a “condominium” concept that
allows a client to “virtually-own” a manufacturing suite for its
process development and production needs. This novel approach provides clients
with complete flexibility in accessing capacity as needed.
Xcellerex Chief Executive Officer Guy Broadbent commented,
“Gallus is capitalizing on the extraordinary flexibility afforded by the FlexFactory,
along with the extensive manufacturing experience of its team, to provide
innovative solutions for established as well as development-stage
biopharmaceutical companies. The agreement provides us with an important path
to offer full-scale commercial manufacturing to our customers.” Separately,
the companies announced that Mr. Broadbent will join the Gallus board of
directors.
