ABLYNX IS GRANTED EXTENDED GMP CERTIFICATE FOR NEW GMP UNIT
(Thomson Reuters ONE) -
GHENT, Belgium, 10 January 2012 - Ablynx [Euronext Brussels: ABLX] today
announced that it has been granted an extended Certificate of Good Manufacturing
Practice (GMP) from the Federal Agency for Medicines and Health Products (FAMHP)
in Belgium for its new GMP unit at its headquarters in Ghent, after having been
inspected in November 2011.
Having received this accreditation, Ablynx's GMP unit will now perform release-
testing on Drug Substance and Drug Product batches and independently perform all
stability studies on these batches. The large scale GMP manufacturing of
Nanobodies® will continue to be outsourced to contract manufacturing
organisations (CMO).
Dr Edwin Moses, CEO and Chairman of Ablynx, commented: "GMP certification of our
laboratories in Ghent is a testament to Ablynx's commitment to consistently
perform at a high standard in our internal and partnered development programmes.
This is an important step forward as we continue to transform into a product-
based company."
About Good Manufacturing Practice
Good Manufacturing Practice (GMP) is that part of a Quality Management System
which ensures that products are consistently produced and controlled to the
quality standards appropriate to their intended use.
About the Federal Agency for Medicines and Health Products
The Federal Agency for Medicines and Health Products (FAMHP) is the competent
authority responsible for the quality, safety and efficacy of medicines and
health products in Belgium.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the discovery and development
of Nanobodies(®), a novel class of therapeutic proteins based on single-domain
antibody fragments, for a range of serious and life-threatening human diseases,
including inflammation, haematology, oncology and pulmonary disease. Today, the
Company has over 25 programmes in the pipeline and seven Nanobodies in clinical
development. Ablynx has ongoing research collaborations and significant
partnerships with major pharmaceutical companies, including Boehringer
Ingelheim, Merck Serono, Novartis, and has had a collaboration with Pfizer. The
Company is headquartered in Ghent, Belgium and currently employs over 290
people. More information can be found on www.ablynx.com.
For more information, please contact Ablynx:
Dr Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
+32 (0)473 39 50 68
e: edwin.moses(at)ablynx.com
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch(at)ablynx.com
Complete version of the press release:
http://hugin.info/137912/R/1576511/491346.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
[HUG#1576511]
Unternehmensinformation / Kurzprofil:
Datum: 10.01.2012 - 18:00 Uhr
Sprache: Deutsch
News-ID 102877
Anzahl Zeichen: 3694
contact information:
Town:
Ghent
Kategorie:
Business News
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