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Date: 28th July 2004
Title: EMEA approves CMC Biopharmaceuticals New 80,000 sqft Copenhagen
Facility for Manufacture of Human Biopharmaceuticals
CMC
Biopharmaceuticals A/S (CMC) has been successfully inspected by the Danish
Medicines Agency (DMA) on behalf of the European Medicines Agency (EMEA)
and has received a European Manufacturing Authorization for its purpose
designed 8,300 square meter (80,000 square foot) contract bio-manufacturing
facility in Copenhagen, Denmark.
CMC is authorized to manufacture and control Active Pharmaceutical Ingredients
(APIs) for Clinical Trial Phases I, II, and III. The authorization covers
CMC's dedicated mammalian and microbial manufacturing lines as well as
Drug Product analysis and release by Qualified Persons. Additionally,
CMC is authorized to do stability studies and to perform release testing
of products imported into EU. The authorization for this new Copenhagen
Facility will be an addition to the current authorization which already
covers CMC's Symbion Facility.
Anders Vinther, Chief Quality Officer at CMC, says "CMC has built
its Quality System to meet the strictest current Good Manufacturing Practices
(cGMP) requirements in both the USA and Europe. The system has been designed
to fully meet the new EU Clinical Trial Directive which sets stricter
manufacturing requirements for the manufacture of API's and Drug Products
in the early clinical phases."
A European Manufacturing Authorization is mandatory when manufacturing
drugs for use in human clinical trials and for products already on the
market. An equivalent of the EMEA authorization does not exist for clinical
drugs which are manufactured in the USA. The European Manufacturing Authorization
ensures that the company meets the requirements of current GMP from the
onset of the first clinical trials (Clinical Phase I). The GMPs set documentation
requirements for every aspect related to the manufacture and control of
human drugs from receiving the raw materials, to quality control and release
of the final API. The GMPs also cover requirements for the qualification
of equipment and systems, training of personnel and document flows.
To accommodate for the increasing number of requests for CMC's services
the company has aligned its Marketing and Business Development structure
thus ensuring a continued flexible and efficient communication and servicing
of our customers. To this end VP Richard Hart is responsible for CMC's
marketing activities and lead generation in Europe assisted by Dir. Joakim
Mikkelsen. Shiva Khalafpour and Thomas Hindle's main responsibilities
are business development and contract negotiations in Europe and North
America, respectively. All three report directly to the Board of Management.
For further information please contact
Quality Organization:
Chief Quality Officer: Anders Vinther
av@cmcbio.com
phone: +45 3954 8404
mobile: +45 2948 8404
Business Development Organization:
V.P. Marketing (UK office, London): Richard Hart
rh@cmcbio.com
phone: +44 1491 681 823
mobile: +44 7793 555 886
Director Marketing (HQ Office, Copenhagen): Joakim Mikkelsen
jm@cmcbio.com
phone: +45 39 54 84 06
mobile: +45 29 48 84 06
V.P. Business Development Europe (UK office, London): Shiva Khalafpour
sk@cmcbio.com
phone: +44 1483 832 860
mobile: +44 7711 917 692
V.P. Business Development North America (US office, Boston): Thomas Hindle,
th@cmcbio.com
phone: +1 603 373 8280
mobile: +1 603 205 9200
URL:
http://www.cmcbiopharmaceuticals.com/images/
28-jul-2004-pressrelease-EMEA-approves-CMC%20Facility.pdf
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