ΔΕΛΤΙΟ
ΤΥΠΟΥ: Η
Βiogenea-Cellgenea διαπιστεύτηκε από την BSR Ingenieur-Buro για τους
υπερκάθαρους εργαστηριακούς της χώρους (cleanrooms), σύμφωνα με το DIN ISO
14644.
Η
Biogenea-Cellgenea Ε.Π.Ε. είναι μια εταιρεία κροσυντήρησης βλαστικών κυττάρων
και βιοθεραπευτικής που εστιάζεται στην παραγωγή cGMP (Σύμφωνα με την Ορθή
Παρασκευαστική Πρακτική) προηγμένων ιατρικών προϊόντων (1394/2007/ΕΕ)
αποκλειστικά για αυτόλογη χρήση από το ομφαλοπλακουντιακό αίμα, το δέρμα, τον
οδοντικό πολφό, τον ιστό ομφάλιου λώρου. Στην προκλινική-ερευνητική φάση
(2008-2009) διαπιστεύτηκε από την BSR Ingenieur-Buro για τους υπερκάθαρους
εργαστηριακούς της χώρους (cleanrooms), σύμφωνα με το DIN ISO 14644.
H
διαπίστευση αυτή αποτελεί την επίσημη, συστημική και τεκμηριωμένη απόδειξη ότι
οι εγκαταστάσεις και ο εξοπλισμός για τις δραστηριότητες επεξεργασίας και
πολλαπλασιασμού βλαστικών κυττάρων ex vivo που μπορούν να πραγματοποιηθούν
είναι κατάλληλες και σύμφωνες με τις έγκυρες οδηγίες και τα πρότυπα DIN EN ISO
14644, VDI 2083, και τις οδηγίες της Ε.Ε. για την Ορθή Παρασκευαστική Πρακτική."Το γραφείο BSR Ingenieur έχει καθιερώσει μια
συγκριτική μέτρηση επιδόσεων για τις προδιαγραφές των υπεκάθαρων εργαστηριακών
χώρων. Όντας η πρώτη βιοτεχνολογική εταιρεία που έχει λάβει αυτή τη
διαπίστευση, η Biogenea-Cellgenea Ε.Π.Ε. αποκτά ηγετική θέση"δήλωσε οκ. Νικόλαος
Γρηγοριάδης, Διευθύνων Σύμβουλος της Βiogenea-Cellgenea Ε.Π.Ε.
PRESS RELEASE 02-01-2007: Today announced that ERP-(Enterprise Resource Planning System) and
it's leading enterprise barcode asset tracking solution was chosen by Biogenea-Cellgenea
Ltd as the leading automatic identification data capture solution provider and
as an independent software vendor partner for its Scientific Stem Cell Partner
Program.
"Biogenea -Cellgenea's ultimate scope is the continuous control and cross-tracking
of the cryopreserved samples with validated ERP software which ensures the
ability to track down and to identify the sample during all the steps of its
supply, the processing, the control, the storage and the distribution. The
tracking is also used for controlling and identifying all the relevant data
about the products and the materials that come in contact with these samples
(2004/23/ΕΚ)." said John Grigoriadis Vice President of Biogenea-Cellgenea Ltd.
"We selected (ERP-Enterprise Resource Planning System) with it's
unique barcode tracking solution which can receive immediate value by extending
such solutions to our scanners giving Biogenea-Cellgena's Ltd users the ability
to utilize mobile devices for data collection from it's Master Stem Cell
Bank." added again Nikolaos Grigoriadis CEO of Biogenea-Cellgenea Ltd.
To address this growing concern, Biogenea-Cellgenea an innovative
Greece-based company, has successfully developed and implemented a proven
solution available. The company's system makes use of barcode technology, a
time-tested answer to the problem of tracking and verification of the samples
during all the steps of its supply, the processing, the control, the storage
and the distribution provides a more reliable and cost effective solution than
other alternatives currently being investigated. To ensure its successful
adoption, the company has also created proprietary software capable of
interfacing with any manufacturer's packaging process and systems.
That proprietary tracking technology will improve Biogenea-Cellgenea's
Commercial Management Sub-system (for example: Management of Reserves, Sales,
Purchases), Advanced Commercial Management, Serial numbering, Lots, Technical
Specifications, Imports Cost Accounting, Sales and Marketing.Economic
Management Sub-system (for example: General Accounting, Management of Accounts
Receivable and Payable, Financial Management, Budget Forecasting), Advanced
Economic Management, Fixed Assets Management.Management Information/ Planning
Sub-system [MIS Components (indicatively Being Line Analytical Processing
(OLAP) Viewer, Hierarchical Data Views (HDVs), Graph Viewer), Query Viewer,
Ready Printings], Advanced Reporting Tools, Budgets Management.
Euro ready, Management of foreign currency, Multi-Company, e-business,
Security System,
"ERP-Enterprise Resource Planning System), enables finally
Biogenea-Cellgenea's Laboratory and Scientific Managers to capture inventory
data, tag and track assets at the receiving dock, and perform audits and
database reconciliation using mobile device hardware from companies Server.
These capabilities enable organizations to achieve up to 99.99 percent or
greater asset database accuracy which in turn helps organizations manage costs,
reduce risk and improve efficiency by managing each step of stem cell ex vivo
manipulations. ERP-Enterprise Resource Planning System) can serve as a
standalone asset repository or a customizable front-end that further extends
the asset management capabilities of Biogenea-Cellgenea's ISO system." said
Nikolaos Grigoriadis CEO of Biogenea - Cellgenea Ltd.
"(ERP-Enterprise Resource Planning System) is
ideal for intermediate enterprises with 1 up to 10 users. It interlinks and
completes the operations the Commercial and Economic Management into a single
powerful comprehensive system, with superior statistical representation. It
adds value to the business operations through the planning capability based on
the availability of resources. It drastically decreases the cost, improves
customer service by decreasing response time though process automation. It
improves decision-making, due to the conversion of statistical accounting data
into dynamic visual stem cell therapy business models." said John
Grigoriadis Vice President of Biogenea-Cellgenea Ltd.
PRESS RELEASE 15-10-2006: Biogenea - CellGenea Ltd a leading provider of stem cells
bioservices today announced the company's continuing expansion with new
offices in Larissa on Panagouli str. 10.
Biogenea - CellGenea Ltd a leading provider
of stem cells bioservices today announced the company's continuing
expansion with new offices in Larissa in October 2006.The opening of new
offices enables Biogenea-CellGenea Ltd to provide better support and
services for its existing customers as well as position the company for
additional growth on Central Greece. Adult stem cells improve healing of broken
bones and could eventually serve as a new treatment up to the 20 to
30 percent of fractures that fail to heal, according to a new study.
Researchers believe a key reason for bone union failure may be a
deficiency in adult stem cells, which normally become reparative cells in
response to damage. These adult stem cells, which can be obtained from a
patient's periosteum (esp. cambium layer) in a minimally invasive
procedure, may improve fracture healing in many patients. "We are
extremely pleased to be opening offices in Larissa which is an important
piece of our Greece's wide strategy," said Nikolaos
Grigoriadis president and CEO of Biogenea-Cellgenea.
These new offices will mainly support the program and
the continuation of future joint activities which focused on the regrowing of
cartilage and support first clinical trial using stem cells to try to
regenerate the knee's shock absorber, a cartilage pad called the meniscus.
Doctors are testing new ways to spur cartilage to regrow in damaged knees, from
implanted "cartilage plugs" to injections of mesenchymal stem cells.
The need is huge. Knees are the joint most likely to go bad, and the cartilage
that cushions them has only a limited natural ability to repair itself.
The potential new healing options are being
tried first in people who injured their knees and thus need small amounts of
cartilage to regrow. But if they truly work, the techniques one day might offer
hope for arthritis sufferers, too, whose cartilage over time completely erodes.
These new offices will
also support Biogenea- Cellgenea's new efforts of winning basic researchers and
medical advisors for the improvement of the healing of the broken bones using
periosteum derived adult stem cells. "Our study will provide
critical scientific data needed to implement a novel therapeutic adult stem
cell therapy and an innovative treatment approach in patients with impaired
fracture healing," John Grigoriadis Vice President of Biogenea-Cellgenea
Ltd added.
Press Release 05-01-2005: Biogenea-Cellgenea Ltd now offering validated Molecular Diagnostics
services provision for the detection of HIV1/2, HBV, HCV, CMV, Syphillis,
Toxoplasma of all cryopreserved and fresh stem cell samples applying Real-Time
PCR technology (Roche LightCycler).
It is expected that this new
equipment could further accelerate Biogenea-Cellgenea's growth on
this rapidly developing technology, increase the variety of tests
available to customers for therapeutic and diagnostic applications.
PCR is a simple yet elegant means by which
virtually unlimited copies of genetic material can be made in a test tube. It
is used in a wide variety of applications, including research, diagnostics,
forensics and other fields. It is used to detect infectious organisms and
monitor disease progression and response to therapy. New applications of the
technique may allow it to predict disease predisposition and individualize
patient therapy, all potentially resulting in earlier treatment and improved
patient care.
Roche is a world leader amongst research-based
companies in the health sector in the field of pharmaceuticals and diagnostics
and has its headquarters in Basel, Switzerland. The innovative products and
services from Roche cover the prevention, diagnosis and treatment of diseases
and contribute to improved well-being and quality of life.Roche's patented
polymerase chain reaction (PCR) technology is one of the most advanced methods
in molecular diagnostics and one that earned its discoverer a Nobel Prize in
Chemistry in 1993. PCR allows minute amounts of genetic material to be
amplified into billions of copies (that is, to detectable levels) in only a few
hours. In addition to its applications in nucleic acid fingerprinting and the
diagnosis and monitoring of disease, PCR enables detection of infectious agents
early on in the infection cycle, often before symptoms appear.
Currently, Biogenea-Cellgenea markets a full line of
stem cell bioservices including collection, manipulation, cryopreservation
and production of stem cells from various human sources like cord blood,
bone marrow, mobilized and unmobilized peripheral blood for the treatment of
devastating diseases and it's scope is to strenghten the quality
using Roche's LightCycler PCR-System and a line of CE reagents from the
PCR market. That combination will provide a fully automated system
for Nucleic Acid Extraction for genetic and clinical applications.
"Biogenea-Cellgenea's
scope is to become one of the leaders in the field of the cell
therapy healthcare groups concetrating its efforts to the principal
businesses of pharmacogenomics, pharmacodiagnostics and dna analysis.
Through the company's Diagnostic Division, innovative services will mainly be
provided to hospitals, clinical laboratories, researchers, physicians and patients
Greece-wide" said Nikolaos Grigoriadis CEO of Biogenea-CellGenea Ltd.