XBiotech Announces Successful Completion of GMP Audit
December 03 2018 - 08:15AM
XBiotech Announces Successful Completion of GMP Audit
XBiotech Inc. (NASDAQ:XBIT) today announced a successful GMP (Good
Manufacturing Practices) audit by Eurofins Amatsigroup. The audit
was conducted in connection with XBiotech’s distribution in Europe
of its US-manufactured biological drug product. XBiotech
manufactures bermekimab at its campus facility in Austin, Texas and
regularly ships the drug to clinics in various countries in the
European Union and the United Kingdom. Drugs manufactured outside
of Europe may only be distributed in Europe through a qualified
organization that can assure quality of drug product and
manufacturing practices. The Company recently retired its old
operations, which included a GMP manufacturing facility,
consolidating its programs in a state-of-the-art manufacturing and
R&D center on its campus in Austin. This is the first audit of
the new facility.
Norma Gonzalez, XBiotech’s Vice President of
Quality, commented, “We are revolutionizing the manufacturing of
biological drugs in many ways, including in terms of robustness and
ease of GMP compliance. We were pleased to be able to once again
demonstrate this in the audit process.”
XBiotech recently consolidated operations
at its new headquarter facility in Austin, Texas. Operations
are now exclusively housed in one complex that includes a
custom-built state-of-the-art manufacturing operation, R&D
laboratories and administrative space. XBiotech’s facilities are
located on a 48 acre estate located only minutes from Austin’s city
center. XBiotech developed manufacturing technology using
bioreactors designed and built by the Company, employing its
technology to dramatically reduced capital costs, plant and
equipment operating complexity, and improve production flexibility
compared to existing manufacturing commonly used to produce
marketed biologics. XBiotech currently produces all of its
clinical drug material and plans to manufacture commercial drug
product from its Austin headquarters.
About True Human™ Therapeutic
AntibodiesXBiotech’s True Human™ antibodies are derived
without modification from individuals who possess natural immunity
to certain diseases. With discovery and clinical programs across
multiple disease areas, XBiotech’s True Human antibodies have the
potential to harness the body’s natural immunity to fight disease
with increased safety, efficacy and tolerability.
About XBiotechXBiotech is a fully
integrated global biosciences company dedicated to pioneering the
discovery, development and commercialization of therapeutic
antibodies based on its True Human™ proprietary technology.
XBiotech currently is advancing a robust pipeline of antibody
therapies to redefine the standards of care in oncology,
inflammatory conditions and infectious diseases. Headquartered in
Austin, Texas, XBiotech also is leading the development of
innovative biotech manufacturing technologies designed to more
rapidly, cost-effectively and flexibly produce new therapies
urgently needed by patients worldwide. For more information, visit
www.xbiotech.com.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements, including declarations regarding management's beliefs
and expectations that involve substantial risks and uncertainties.
In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "would," "could,"
"expects," "plans," "contemplate," "anticipates," "believes,"
"estimates," "predicts," "projects," "intend" or "continue" or the
negative of such terms or other comparable terminology, although
not all forward-looking statements contain these identifying words.
Forward-looking statements are subject to inherent risks and
uncertainties in predicting future results and conditions that
could cause the actual results to differ materially from those
projected in these forward-looking statements. These risks and
uncertainties are subject to the disclosures set forth in the "Risk
Factors" section of certain of our SEC filings. Forward-looking
statements are not guarantees of future performance, and our actual
results of operations, financial condition and liquidity, and the
development of the industry in which we operate, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements that we make in this
press release speak only as of the date of this press release. We
assume no obligation to update our forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
Photos accompanying this announcement are available
athttp://www.globenewswire.com/NewsRoom/AttachmentNg/0558d76a-c4f4-40d7-8c41-808480a0a320http://www.globenewswire.com/NewsRoom/AttachmentNg/593d4948-7cd5-452e-8cc3-fa0745641503http://www.globenewswire.com/NewsRoom/AttachmentNg/033b92f0-7956-49d8-bf22-b6984b45211a
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