| • September
04 - New website for cGMP biomanufacturing arm PX’Pharma |
PX’Pharma
SAS is the fully-owned subsidiary of Protein’eXpert
dedicated to the contract manufacture of pharmaceutical grade
proteins to be tested in early phase clinical trials. PX’Pharma’s
mission is to help therapeutic protein candidates progress
swiftly form late-stage research into the clinic.
The company was set up in late
2003 and started manufacturing therapeutic proteins for early
clinical trials on schedule during late Q3 in 2004. PX’Pharma
operates state-of-the-art cGMP facilities for the manufacture
of clinical grade candidate therapeutic proteins which are
dedicated to early stage clinical trials. |
| |
| • 22
to 24 June 04 - Protein'eXpert at bioLOGIC Europe 2004, Geneva,
Switzerland |
bioLOGIC Europe,
the major strategic biomanufacturing event, is now entering
its 5th successful year.
Meet Protein'eXpert and other leaders in the biomanufacturing market at the
President Wilson Hotel ,Geneva.
BioLOGIC
Europe 2004 |
| |
| • 6
to 9 June 04 - Protein'eXpert at Bio 2004 Convention, San Francisco, USA
(Booth # 839 Biobusiness in Rhone-Alpes) |
Bio 2004 takes
place in San Francisco (Moscone Convention Centre) , USA
between 6 and 9 June 2004. A unique opportunity to meet up
and discuss your target and therapeutic protein-related developments.
We can meet during 1to1 meetings or alternatively on the Rhône-Alpes region
booth (#839).
You will find more information about the event on the Bio
Website |
| |
| • March
04 - PX Positions PX'Pharma as Therapeutic Protein Production
Arm |
Listen to Tristan
Rousselle's interview by Pascal Le Guern on 'France
Info' - Top French News Broadcaster (Anvar's Newscast)
- 26 February 2004:
2-minute audio file , interview in French language |
| |
| • March
04 - PX'Pharma Setup on Track for Operational Start in Q3-2004 |
PX’Pharma SAS is actively ramping
up to start biomanufacturing GMP-grade therapeutic proteins
for clinical trials in the second half of 2004. The CMO’s modular
manufacturing suite has been erected in February and is currently
being equipped with state-of-the-art apparatus, a phase which
will be closely followed by the equipment’s qualification procedure.
The purpose-built facility will be audited by French authority
AFSSAPS (French Health Products Safety Agency) during the summer
of 2004, to be followed by an EMEA inspection.
Protein’eXpert’s fully owned subsidiary Px'Pharma offers
integrated programs designed to maximize a candidate therapeutic protein’s
chances of flowing through one of the riskiest phases of protein drug development
(preclinical & early clinical trials down to phase II). The CMO operates
a multi-system & expandable cGMP manufacturing facility in Grenoble,
S.E. France. The purpose-built modular suite manufactures therapeutic grade
recombinant proteins. These proteins are candidate biopharmaceuticals which
are tested during preclinical and early clinical trials. |
| |
| • Protein'eXpert at BioSquare Partnering
Convention - 11 & 12 March 2004, Basel, CH |
| Biosquare 2004 takes place in Basel ('Messe
Schweiz' Convention Centre) , Switzerland on 11 and 12 March
2004. A unique opportunity to meet up and discuss target and
therapeutic protein-related developments. You will find more
information about the event on the BioSquare
Website |
| |
| • Pro'Xtest – Discover our Protein & Data
Fast Track Service |
| Pro’Xtest is a proprietary high-throughput
protein expression service based upon fast, parallel and reliable
protocols designed to deliver highly valuable data about the
genes of interest. Pro’Xtest test also enables the delivery
of up to 1 mg of purified proteins within an average four weeks.
Pro’Xtest is ideal for research scientists looking to rely
on a fast but qualitative protein expression diagnosis service.
Because the service is performed on our High Throughput Protein
Generator platform, it is capable of processing up to 50 of
your compounds per monthly run (up to 1mg output per protein). |
| |
| • Protein'eXpert gathers 1.3 million Euros
to fund PX'Pharma - Therapeutic Protein Biomanufacturing |
November 2003 - Protein’eXpert has gathered
3 years of experience as a leading specialist of recombinant
protein engineering and target protein production. In order
to consolidate its development, the Grenoble-based biotech
has secured €1.3 million of funding with various institutional
investors operating in the Rhône-Alpes region. The funds will
be invested in Protein’eXpert’s upcoming biomanufacturing facility
which will produce therapeutic proteins to cGMP* standards
from 2004.
Three regional venture capital companies specializing in seed funding,
namely Amorçage Rhône-Alpes (Champagne au Mont d’Or), Rhône Alpes Création
(Champagne au Mont d’Or) and Rhône Dauphiné Développement (Meylan) have
chosen to invest in the venture. Two banking institutions, BNP Paribas
and Crédit Coopératif, are also taking part. ANVAR, France’s national
agency for the promotion of Innovation and also one of Protein’eXpert’s
historical partners, is renewing its support. Furthermore, Mr. Claude
GROS, President of Sabeton Holdings, is reinforcing its shareholding
in Protein’eXpert. Lastly, the company will benefit from a CROC grant
(Regional Contract for Growth).
With the development of its pharmaceutical activities, which will be
administered by sister company Px'Pharma,
Protein’eXpert will gain access to the fast growing therapeutic protein
market. This market was estimated by Reuters at USD 33.4 billion in 2002,
one that is marked by a tendency for large pharmaceutical groups to outsource
manufacturing steps. Moreover, the market is characterised by scarce
GMP biomanufacturing capacity.
*cGMP standard: (current) Good Manufacturing
Practice, which is the standard to which Active
Pharmaceutical Ingredients are manufactured.
Delivered by AFSSAPS in France, EMEA in Europe
and the FDA in the USA. |
| |
| • Feb
04 - Protein'eXpert granted ISO 9001 Label by BVQI
|
|
Protein’eXpert SA has been successfully
audited by Quality Assurance specialists BVQI for the ISO
9000:2000 standard in February 2004. The ISO-compliant Quality
Management System will be Protein’eXpert’s main management
tool and has therefore been implemented across all departments
including Development. The QA system is an essential stepping
stone towards the start of pharmaceutical biomanufacturing
which is due later on into 2004. Indeed, PX’Pharma, a fully
owned subsidiary of Protein’eXpert, is on track to start
manufacturing protein APIs for early clinical trials from
the second half of 2004 onwards.
“A global project which has taken almost two years of intensive work and commitment
by all staff, the ISO 9000 certified quality assurance system enables Protein’eXpert
to deliver top-class protein services to our demanding customers in a consistent
manner. We are confident that the systems in place will help us towards GMP compliance
for PX’Pharma’s upcoming debut scheduled in Q3-2004.” – Dr. Lucile Marron-Brignone,
IP & Quality Director.
|
| |
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