SlideShare a Scribd company logo

Γιώργος Βαρδαμίδης, 11th Clinical Research Conference

DEMO’s investment in Biotechnology – Development and Production of Monoclonal Antibodies

1 of 20
Download to read offline
11th Clinical Research Conference
DEMO’s investment in Biotechnology
–
Development and Production of Monoclonal Antibodies
Γιώργος Βαρδαμίδης
Quality Assurance Manager
Biotechnology Operations
Contents
DΕΜΟ Pharmaceutical
Investments of DEMO in Biotechnology
Biological Pharmaceutical Products
Manufacturing Process of Monoclonal
Antibodies (mAbs)
Bio - Academy
Biosimilar Development and Clinical
Studies
1
2
3
Specialized in the Development
and Production of Injectables
Ranked #1 in hospital sales in Greece
(in terms of sold units)
Ranked #1 in exports of branded products
Ranked #1 in production facilities for injectables
 4 Manufacturing Plants
 25 Production Lines
 20 Packaging Lines
 The first manufacturing plant in Greece filling injectables in plastic ampoules
 The largest pharmaceutical manufacturing complex of Southeastern Europe with a global reach
Total area exceeding 66.000m2
New Countries 2021: Νepal, Paraguay
78,8%
Of the company’s annual production
is exported to international markets
“Active” in 96 countries as of 31.5.2016
Own branded products in 85 countries
2.926 approved products,
527 products under approval
Internationally Recognized
Quality Accreditations
• Officially Approved Supplier of the United Nations, UNICEF,
World Health Organization, Medicines Sans Frontiers, International Co
mmittee of the Red Cross
• Approved by PIC/s countries (Europe, Switzerland, Canada, Australia)
• Approved by the Korean-FDA
• Approved by Brazilian Drug Agency (ANVISA)
• Approved by GCC (Health Minister’s Council for Cooperation
Council States) – Gulf countries
• Many other health authorities of non-EU countries
(China, Jordan, South Africa MCC, Egypt, Turkey, Yemen, etc)
EU cGMP certified (current Good Manufacturing Practices)
ISO-9001, ISO-13485, ISO 14001:2015, ISO 45001:2018
Ad

Recommended

Anteo Diagnostics Microcap Presentation October 2013
Anteo Diagnostics Microcap Presentation October 2013Anteo Diagnostics Microcap Presentation October 2013
Anteo Diagnostics Microcap Presentation October 2013Matt Sanderson
 
Bioprocessing bioanalytics-congress-europe-agenda-18 (1)
Bioprocessing bioanalytics-congress-europe-agenda-18 (1)Bioprocessing bioanalytics-congress-europe-agenda-18 (1)
Bioprocessing bioanalytics-congress-europe-agenda-18 (1)Tony Couch
 
Tracking cmo investments in biologics
Tracking cmo investments in biologicsTracking cmo investments in biologics
Tracking cmo investments in biologics碩彥 徐
 
Biopharmaceutical Process Development: Good Manufacturing Practices or Breaki...
Biopharmaceutical Process Development: Good Manufacturing Practices or Breaki...Biopharmaceutical Process Development: Good Manufacturing Practices or Breaki...
Biopharmaceutical Process Development: Good Manufacturing Practices or Breaki...Chris Willmott
 
Yaohai Bio-pharmaceutical Overview_Jason 202212V2.pdf
Yaohai Bio-pharmaceutical Overview_Jason 202212V2.pdfYaohai Bio-pharmaceutical Overview_Jason 202212V2.pdf
Yaohai Bio-pharmaceutical Overview_Jason 202212V2.pdfJasonSoung
 
MAKING HEALTHCARE MORE ACCESSIBLE
MAKING HEALTHCARE MORE ACCESSIBLEMAKING HEALTHCARE MORE ACCESSIBLE
MAKING HEALTHCARE MORE ACCESSIBLEiQHub
 
BioSimilar Drug Development World
BioSimilar Drug Development WorldBioSimilar Drug Development World
BioSimilar Drug Development WorldGeneric Pharma 2.0
 

More Related Content

Similar to Γιώργος Βαρδαμίδης, 11th Clinical Research Conference

Biosimilar : A Biologic Drug Revolution.
Biosimilar : A Biologic Drug Revolution.Biosimilar : A Biologic Drug Revolution.
Biosimilar : A Biologic Drug Revolution.Yogeshwary Bhongade
 
Paradigm Change in Biomanufacturing
Paradigm Change in Biomanufacturing Paradigm Change in Biomanufacturing
Paradigm Change in Biomanufacturing PnuVax
 
5th Lyophilisation (2011) Fb
5th Lyophilisation (2011) Fb5th Lyophilisation (2011) Fb
5th Lyophilisation (2011) FbFateja
 
Rice Bran Neutraceuticals
Rice Bran NeutraceuticalsRice Bran Neutraceuticals
Rice Bran NeutraceuticalsAmr Helal
 
Rdi azhar workshop
Rdi   azhar workshopRdi   azhar workshop
Rdi azhar workshopAmr Helal
 
Synthon, The Value Chain of a specialty pharmaceutical company
Synthon, The Value Chain of a specialty pharmaceutical companySynthon, The Value Chain of a specialty pharmaceutical company
Synthon, The Value Chain of a specialty pharmaceutical companyHealth Valley
 
CORBEL BBMRI-ERIC QM webinar slides
CORBEL BBMRI-ERIC QM webinar slidesCORBEL BBMRI-ERIC QM webinar slides
CORBEL BBMRI-ERIC QM webinar slidesCORBEL
 
Dyadic C1 Family Office Opportunity
Dyadic C1 Family Office OpportunityDyadic C1 Family Office Opportunity
Dyadic C1 Family Office OpportunityDyadic
 
The C1 Expression System Reinventing Biologic Drug Production
The C1 Expression System Reinventing Biologic Drug Production The C1 Expression System Reinventing Biologic Drug Production
The C1 Expression System Reinventing Biologic Drug Production Mark Emalfarb
 
Pharmaceutical Industry
Pharmaceutical IndustryPharmaceutical Industry
Pharmaceutical IndustryNani Masters
 
5th Annual Recombinant Antibodies (2012) Pp
5th Annual Recombinant Antibodies (2012) Pp5th Annual Recombinant Antibodies (2012) Pp
5th Annual Recombinant Antibodies (2012) PpPiyush Patel
 
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...Business Turku
 
Roundup of This Year's AACC Meeting in Atlanta
Roundup of This Year's AACC Meeting in AtlantaRoundup of This Year's AACC Meeting in Atlanta
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
 
Biosimilars global congress 2014 europe copy 3 (6)
Biosimilars global congress 2014 europe  copy 3 (6)Biosimilars global congress 2014 europe  copy 3 (6)
Biosimilars global congress 2014 europe copy 3 (6)chetanpatel73
 

Similar to Γιώργος Βαρδαμίδης, 11th Clinical Research Conference (20)

Biosimilar : A Biologic Drug Revolution.
Biosimilar : A Biologic Drug Revolution.Biosimilar : A Biologic Drug Revolution.
Biosimilar : A Biologic Drug Revolution.
 
Bio-XL May 2017
Bio-XL May 2017Bio-XL May 2017
Bio-XL May 2017
 
Paradigm Change in Biomanufacturing
Paradigm Change in Biomanufacturing Paradigm Change in Biomanufacturing
Paradigm Change in Biomanufacturing
 
5th Lyophilisation (2011) Fb
5th Lyophilisation (2011) Fb5th Lyophilisation (2011) Fb
5th Lyophilisation (2011) Fb
 
Prof. Melissa Hanna-Brown
Prof. Melissa Hanna-BrownProf. Melissa Hanna-Brown
Prof. Melissa Hanna-Brown
 
Rice Bran Neutraceuticals
Rice Bran NeutraceuticalsRice Bran Neutraceuticals
Rice Bran Neutraceuticals
 
Rdi azhar workshop
Rdi   azhar workshopRdi   azhar workshop
Rdi azhar workshop
 
Synthon, The Value Chain of a specialty pharmaceutical company
Synthon, The Value Chain of a specialty pharmaceutical companySynthon, The Value Chain of a specialty pharmaceutical company
Synthon, The Value Chain of a specialty pharmaceutical company
 
CORBEL BBMRI-ERIC QM webinar slides
CORBEL BBMRI-ERIC QM webinar slidesCORBEL BBMRI-ERIC QM webinar slides
CORBEL BBMRI-ERIC QM webinar slides
 
Dyadic C1 Family Office Opportunity
Dyadic C1 Family Office OpportunityDyadic C1 Family Office Opportunity
Dyadic C1 Family Office Opportunity
 
The C1 Expression System Reinventing Biologic Drug Production
The C1 Expression System Reinventing Biologic Drug Production The C1 Expression System Reinventing Biologic Drug Production
The C1 Expression System Reinventing Biologic Drug Production
 
Pharmaceutical Industry
Pharmaceutical IndustryPharmaceutical Industry
Pharmaceutical Industry
 
Biotech areas
Biotech areasBiotech areas
Biotech areas
 
5th Annual Recombinant Antibodies (2012) Pp
5th Annual Recombinant Antibodies (2012) Pp5th Annual Recombinant Antibodies (2012) Pp
5th Annual Recombinant Antibodies (2012) Pp
 
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...
 
Roundup of This Year's AACC Meeting in Atlanta
Roundup of This Year's AACC Meeting in AtlantaRoundup of This Year's AACC Meeting in Atlanta
Roundup of This Year's AACC Meeting in Atlanta
 
Biosimilars global congress 2014 europe copy 3 (6)
Biosimilars global congress 2014 europe  copy 3 (6)Biosimilars global congress 2014 europe  copy 3 (6)
Biosimilars global congress 2014 europe copy 3 (6)
 
NeoFluidics Web Summit 2015
NeoFluidics Web Summit 2015NeoFluidics Web Summit 2015
NeoFluidics Web Summit 2015
 
14-6-Monge
14-6-Monge14-6-Monge
14-6-Monge
 
Pbio 8 8-2013
Pbio 8 8-2013Pbio 8 8-2013
Pbio 8 8-2013
 

More from Starttech Ventures

Γιάννης Χονδρέλης, 11th Clinical Research Conference
Γιάννης Χονδρέλης, 11th Clinical Research ConferenceΓιάννης Χονδρέλης, 11th Clinical Research Conference
Γιάννης Χονδρέλης, 11th Clinical Research ConferenceStarttech Ventures
 
Παναγιώτης Παπαναγιώτου, 8th MedTech Conference
Παναγιώτης Παπαναγιώτου, 8th MedTech ConferenceΠαναγιώτης Παπαναγιώτου, 8th MedTech Conference
Παναγιώτης Παπαναγιώτου, 8th MedTech ConferenceStarttech Ventures
 
Θεοδόσιος Μπίσδας, 8th MedTech Conference
Θεοδόσιος Μπίσδας, 8th MedTech ConferenceΘεοδόσιος Μπίσδας, 8th MedTech Conference
Θεοδόσιος Μπίσδας, 8th MedTech ConferenceStarttech Ventures
 
Γιώργος Μοσχοβάκης, 8th MedTech Conference
Γιώργος Μοσχοβάκης, 8th MedTech ConferenceΓιώργος Μοσχοβάκης, 8th MedTech Conference
Γιώργος Μοσχοβάκης, 8th MedTech ConferenceStarttech Ventures
 
Θανάσης Πετμεζάς, 8th MedTech Conference
Θανάσης Πετμεζάς, 8th MedTech ConferenceΘανάσης Πετμεζάς, 8th MedTech Conference
Θανάσης Πετμεζάς, 8th MedTech ConferenceStarttech Ventures
 
Λεωνίδας Βαλάσας, 8th MedTech Conference
Λεωνίδας Βαλάσας, 8th MedTech ConferenceΛεωνίδας Βαλάσας, 8th MedTech Conference
Λεωνίδας Βαλάσας, 8th MedTech ConferenceStarttech Ventures
 
Νικόλαος Κουρεντζής, 8th MedTech Conference
Νικόλαος Κουρεντζής, 8th MedTech ConferenceΝικόλαος Κουρεντζής, 8th MedTech Conference
Νικόλαος Κουρεντζής, 8th MedTech ConferenceStarttech Ventures
 
Στέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Στέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςΣτέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Στέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Ηλίας Γεωργουλέας, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Γεωργουλέας,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΗλίας Γεωργουλέας,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Γεωργουλέας, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Ηλίας Λεκκός, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Λεκκός,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΗλίας Λεκκός,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Λεκκός, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Ανδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ανδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςΑνδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ανδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Dr. Thorsten Guthke, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Dr. Thorsten Guthke,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςDr. Thorsten Guthke,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Dr. Thorsten Guthke, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Μάνος Δροσατάκης, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Μάνος Δροσατάκης,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΜάνος Δροσατάκης,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Μάνος Δροσατάκης, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Βύρων Κοτζαμάνης, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Βύρων Κοτζαμάνης,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΒύρων Κοτζαμάνης,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Βύρων Κοτζαμάνης, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Tim Currell, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Tim Currell,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςTim Currell,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Tim Currell, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςStarttech Ventures
 
Δημήτρης Αλεξάνδρου
Δημήτρης ΑλεξάνδρουΔημήτρης Αλεξάνδρου
Δημήτρης ΑλεξάνδρουStarttech Ventures
 
Δημήτριος Τσεκούρας
Δημήτριος ΤσεκούραςΔημήτριος Τσεκούρας
Δημήτριος ΤσεκούραςStarttech Ventures
 
Κωνσταντίνος Ουζούνης
Κωνσταντίνος ΟυζούνηςΚωνσταντίνος Ουζούνης
Κωνσταντίνος ΟυζούνηςStarttech Ventures
 
Νικόλαος Πολύζος
Νικόλαος ΠολύζοςΝικόλαος Πολύζος
Νικόλαος ΠολύζοςStarttech Ventures
 

More from Starttech Ventures (20)

Γιάννης Χονδρέλης, 11th Clinical Research Conference
Γιάννης Χονδρέλης, 11th Clinical Research ConferenceΓιάννης Χονδρέλης, 11th Clinical Research Conference
Γιάννης Χονδρέλης, 11th Clinical Research Conference
 
Παναγιώτης Παπαναγιώτου, 8th MedTech Conference
Παναγιώτης Παπαναγιώτου, 8th MedTech ConferenceΠαναγιώτης Παπαναγιώτου, 8th MedTech Conference
Παναγιώτης Παπαναγιώτου, 8th MedTech Conference
 
Θεοδόσιος Μπίσδας, 8th MedTech Conference
Θεοδόσιος Μπίσδας, 8th MedTech ConferenceΘεοδόσιος Μπίσδας, 8th MedTech Conference
Θεοδόσιος Μπίσδας, 8th MedTech Conference
 
Γιώργος Μοσχοβάκης, 8th MedTech Conference
Γιώργος Μοσχοβάκης, 8th MedTech ConferenceΓιώργος Μοσχοβάκης, 8th MedTech Conference
Γιώργος Μοσχοβάκης, 8th MedTech Conference
 
Θανάσης Πετμεζάς, 8th MedTech Conference
Θανάσης Πετμεζάς, 8th MedTech ConferenceΘανάσης Πετμεζάς, 8th MedTech Conference
Θανάσης Πετμεζάς, 8th MedTech Conference
 
Λεωνίδας Βαλάσας, 8th MedTech Conference
Λεωνίδας Βαλάσας, 8th MedTech ConferenceΛεωνίδας Βαλάσας, 8th MedTech Conference
Λεωνίδας Βαλάσας, 8th MedTech Conference
 
Νικόλαος Κουρεντζής, 8th MedTech Conference
Νικόλαος Κουρεντζής, 8th MedTech ConferenceΝικόλαος Κουρεντζής, 8th MedTech Conference
Νικόλαος Κουρεντζής, 8th MedTech Conference
 
Στέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Στέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςΣτέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Στέργιος Μπακάλης & Γεώργιος Μπήτρος, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Ηλίας Γεωργουλέας, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Γεωργουλέας,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΗλίας Γεωργουλέας,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Γεωργουλέας, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Ηλίας Λεκκός, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Λεκκός,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΗλίας Λεκκός,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Ηλίας Λεκκός, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Ανδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ανδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής ΑσφάλισηςΑνδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Ανδρέας Χατζηκύρου, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Dr. Thorsten Guthke, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Dr. Thorsten Guthke,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςDr. Thorsten Guthke,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Dr. Thorsten Guthke, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Μάνος Δροσατάκης, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Μάνος Δροσατάκης,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΜάνος Δροσατάκης,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Μάνος Δροσατάκης, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Βύρων Κοτζαμάνης, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Βύρων Κοτζαμάνης,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςΒύρων Κοτζαμάνης,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Βύρων Κοτζαμάνης, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Tim Currell, 4o Συνέδριο Επαγγελματικής Ασφάλισης
Tim Currell,  4o Συνέδριο Επαγγελματικής ΑσφάλισηςTim Currell,  4o Συνέδριο Επαγγελματικής Ασφάλισης
Tim Currell, 4o Συνέδριο Επαγγελματικής Ασφάλισης
 
Ilias E. Xirouhakis
Ilias E. XirouhakisIlias E. Xirouhakis
Ilias E. Xirouhakis
 
Δημήτρης Αλεξάνδρου
Δημήτρης ΑλεξάνδρουΔημήτρης Αλεξάνδρου
Δημήτρης Αλεξάνδρου
 
Δημήτριος Τσεκούρας
Δημήτριος ΤσεκούραςΔημήτριος Τσεκούρας
Δημήτριος Τσεκούρας
 
Κωνσταντίνος Ουζούνης
Κωνσταντίνος ΟυζούνηςΚωνσταντίνος Ουζούνης
Κωνσταντίνος Ουζούνης
 
Νικόλαος Πολύζος
Νικόλαος ΠολύζοςΝικόλαος Πολύζος
Νικόλαος Πολύζος
 

Recently uploaded

Seminario biología molecular Kevin Duque
Seminario biología molecular Kevin DuqueSeminario biología molecular Kevin Duque
Seminario biología molecular Kevin Duquekevinestebanduque
 
(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj
(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj
(DENGUE).pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.JULIANA BENAVIDES GUERRERO
 
PTERYGIUM ,clinical picture and its management.pptx
PTERYGIUM ,clinical picture and its management.pptxPTERYGIUM ,clinical picture and its management.pptx
PTERYGIUM ,clinical picture and its management.pptxvideosfildr
 
1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdf1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdfHongBiThi1
 
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...leejalashrestha2
 
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...bkling
 
Presentation on Cerebral Palsy and its orthotic management
Presentation on Cerebral Palsy and its orthotic managementPresentation on Cerebral Palsy and its orthotic management
Presentation on Cerebral Palsy and its orthotic managementeshasmalik27
 
Measles.pptx Department of Physiotherapy, SHUATS, Prayagraj
Measles.pptx Department of Physiotherapy, SHUATS, PrayagrajMeasles.pptx Department of Physiotherapy, SHUATS, Prayagraj
Measles.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Seminario Biología Molecular - Susana Cano V.pdf
Seminario Biología Molecular - Susana Cano V.pdfSeminario Biología Molecular - Susana Cano V.pdf
Seminario Biología Molecular - Susana Cano V.pdfsusiedapp
 
Macquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPTMacquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPTMQ_Library
 
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...semualkaira
 
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajPoliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Psychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated CarePsychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated CareBrian Peacock
 
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajTyphoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Seminario Biología Molecular Manuela Álvarez Ramírez
Seminario Biología Molecular Manuela Álvarez RamírezSeminario Biología Molecular Manuela Álvarez Ramírez
Seminario Biología Molecular Manuela Álvarez Ramírezmanuelaalvarezr
 
Scanning electron microscope - SEM , Its applicability in rasashastra
Scanning electron microscope - SEM , Its applicability in rasashastraScanning electron microscope - SEM , Its applicability in rasashastra
Scanning electron microscope - SEM , Its applicability in rasashastraDr. Madduru Muni Haritha
 
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...Subrata Roy
 
Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...
Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...
Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...Golden Helix
 
how to look more attractive? | Boys Edition
how to look more attractive? | Boys Editionhow to look more attractive? | Boys Edition
how to look more attractive? | Boys Editionalibieb33d
 

Recently uploaded (20)

Seminario biología molecular Kevin Duque
Seminario biología molecular Kevin DuqueSeminario biología molecular Kevin Duque
Seminario biología molecular Kevin Duque
 
(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj
(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj
(DENGUE).pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.
 
PTERYGIUM ,clinical picture and its management.pptx
PTERYGIUM ,clinical picture and its management.pptxPTERYGIUM ,clinical picture and its management.pptx
PTERYGIUM ,clinical picture and its management.pptx
 
1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdf1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdf
 
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
 
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...
Report Back from San Antonio Breast Cancer Symposium (SABCS) 2023: Spotlight ...
 
Presentation on Cerebral Palsy and its orthotic management
Presentation on Cerebral Palsy and its orthotic managementPresentation on Cerebral Palsy and its orthotic management
Presentation on Cerebral Palsy and its orthotic management
 
Measles.pptx Department of Physiotherapy, SHUATS, Prayagraj
Measles.pptx Department of Physiotherapy, SHUATS, PrayagrajMeasles.pptx Department of Physiotherapy, SHUATS, Prayagraj
Measles.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Seminario Biología Molecular - Susana Cano V.pdf
Seminario Biología Molecular - Susana Cano V.pdfSeminario Biología Molecular - Susana Cano V.pdf
Seminario Biología Molecular - Susana Cano V.pdf
 
Macquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPTMacquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPT
 
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
 
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajPoliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Psychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated CarePsychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated Care
 
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajTyphoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Seminario Biología Molecular Manuela Álvarez Ramírez
Seminario Biología Molecular Manuela Álvarez RamírezSeminario Biología Molecular Manuela Álvarez Ramírez
Seminario Biología Molecular Manuela Álvarez Ramírez
 
Scanning electron microscope - SEM , Its applicability in rasashastra
Scanning electron microscope - SEM , Its applicability in rasashastraScanning electron microscope - SEM , Its applicability in rasashastra
Scanning electron microscope - SEM , Its applicability in rasashastra
 
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
 
Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...
Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...
Analyzing Performance of the Twist Exome with CNV Backbone at Various Probe D...
 
how to look more attractive? | Boys Edition
how to look more attractive? | Boys Editionhow to look more attractive? | Boys Edition
how to look more attractive? | Boys Edition
 

Γιώργος Βαρδαμίδης, 11th Clinical Research Conference

  • 1. 11th Clinical Research Conference DEMO’s investment in Biotechnology – Development and Production of Monoclonal Antibodies Γιώργος Βαρδαμίδης Quality Assurance Manager Biotechnology Operations
  • 2. Contents DΕΜΟ Pharmaceutical Investments of DEMO in Biotechnology Biological Pharmaceutical Products Manufacturing Process of Monoclonal Antibodies (mAbs) Bio - Academy Biosimilar Development and Clinical Studies
  • 3. 1 2 3 Specialized in the Development and Production of Injectables Ranked #1 in hospital sales in Greece (in terms of sold units) Ranked #1 in exports of branded products Ranked #1 in production facilities for injectables
  • 4.  4 Manufacturing Plants  25 Production Lines  20 Packaging Lines  The first manufacturing plant in Greece filling injectables in plastic ampoules  The largest pharmaceutical manufacturing complex of Southeastern Europe with a global reach Total area exceeding 66.000m2
  • 5. New Countries 2021: Νepal, Paraguay 78,8% Of the company’s annual production is exported to international markets “Active” in 96 countries as of 31.5.2016 Own branded products in 85 countries 2.926 approved products, 527 products under approval
  • 6. Internationally Recognized Quality Accreditations • Officially Approved Supplier of the United Nations, UNICEF, World Health Organization, Medicines Sans Frontiers, International Co mmittee of the Red Cross • Approved by PIC/s countries (Europe, Switzerland, Canada, Australia) • Approved by the Korean-FDA • Approved by Brazilian Drug Agency (ANVISA) • Approved by GCC (Health Minister’s Council for Cooperation Council States) – Gulf countries • Many other health authorities of non-EU countries (China, Jordan, South Africa MCC, Egypt, Turkey, Yemen, etc) EU cGMP certified (current Good Manufacturing Practices) ISO-9001, ISO-13485, ISO 14001:2015, ISO 45001:2018
  • 7. 1.214 Employees *December 2022 53% 47% 0 200 400 600 800 1000 1200 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 963 928 1.025 1.214* As a result of expansion in new markets along with the investments performed during the last decade DEMO has created and keeps creating job openings and career opportunities
  • 8. NEW INVESTMENT PLAN 2021-2027: 356 million € 1. State of the art facility for the development of monoclonal antibodies and a BioAcademy, Attica 2. 4 units for the production of raw materials and 6 units to produce final products, Tripoli 3. Modern R&D laboratories, Thessaloniki 4. Expansion of production in Krioneri, Attica
  • 9. Fully equipped with state of the art production scale machinery and instrumentation Total Area > 2.000 sq.m. 1 Fully Trained Personnel Continuous recruitment of Scientists Collaboration with Academia 2 State of the Art Pilot plant to produce biopharmaceuticals
  • 10. Fully equipped with state of the art lab scale machinery and instrumentation Total Area > 1.000 sq.m. 1 Fully Trained Personnel Continuous recruitment of Scientists Collaboration with Academia 2 State of the Art R&D and QC Laboratories
  • 11. Biologic Drugs • Biotechnological drugs, also known as biological drugs, are a special category of drugs that are made exclusively from living organisms in contrast to conventional small molecule drugs which are chemicals that can be produced through chemical synthesis. • Monoclonal Antibodies : • Able to recognize and attach to specific antigens • Able to circulate in plasma for long time
  • 12. Development and Manufacturing Process of mAb​ OVERVIEW​ Cell Line Develo pment and Cell Banking Process Develo pment Manufacturing Fill & Finish Analytical Analytical
  • 14. Pharmaceutical Features​ Questions to Answer​ Identity​ Is the Protein that I have the one I want ?​ Content/​ Purity​ How much Target Protein is there?/ What else is there and in what Quantity ?​ Activity​ How active is the product with regard to a defined pharmaceutical property in the biological system ?​ Appearance​ What does the product look like ?​ Stability​ How do these five preceding parameters change time or varying physical conditions ?​ Biosimilarity​ All the above tested in comparison to the reference product​
  • 15. QC Batch Release Assays Safety Bioburden Safety Endotoxin General Appearance (colour and clarity) General pH General Concentration Identity Peptide Mapping Identity IEF/cIEF Purity SDS-PAGE/CE-SDS Purity SEC-HPLC Potency Cell Based Assay Potency Antigen Binding Impurities HCP Impurities Residual Protein A Analytical Methods – Quality Control
  • 16. Fully equipped with state of the art lab scale machinery and instrumentation Total Area > 1.000 sq.m. 1 Recruitment of new scientists from Universities and training on the production of biologics under GMP Collaboration with Academia 2 Establishment of Bio - Academy
  • 17. Biosimilar Development and Clinical Studies Source: European Medicines Agency • Biosimilar Development is comparative and progresses in a step – wise manner. • In vitro studies compare the protein structure and biological function between the biosimilar and its reference medicine. • The non-clinical and clinical data needed to approve a biosimilar are different from those needed for a biological medicine with a new active substance. • By demonstrating biosimilarity, the biosimilar relies on the safety and efficacy experience gained with the reference medicine.
  • 18. Biosimilars Are Not Generics Biosimilars and generic drugs are both versions of original brand-name medicines that may offer patients more affordable treatment options. There are, however, important differences: • Generic drugs are usually chemically synthesized while biological products, including biosimilars, are generally manufactured from living sources. • Because the active ingredients of generic drugs generally are smaller and simpler, they are usually easier to copy. • Biologics generally cannot be copied exactly, because the product (e.g., monoclonal antibody) contains a mix of many slight variations of a given protein that occurs during its production from living sources, which introduces inherent variation. FDA Level 1_Slides_Foundational Concepts_v3
  • 19. Our Ιmpact New Pilot Plant and R&D facilities dedicated for the development and manufacturing of biopharmaceuticals DEMO SA will invest 100 million € in the next 10 years for the development and production of monoclonal Antibodies (Biosimilars) produced in mammalian cell lines New Job Openings including High Skilled Professionals Contribution to Brain Gain Aim to enhance Collaboration with Academia in Greece Need for Clinical Studies for the mAbs which will be developed and produced at the DEMO facility.