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Biopharmaceuticals

We offer process development and GMP production for all kind of recombinant proteins - antibodies, hormones, antigens, enzymes - from first-in-man projects up to in-market supply.

 

Reference Projects

CUSTOMER/PARTNERPRODUCTSCOPE AT POLYMUNSTATUS
Gedeon Richter
Hungary
rhFSH (biosimilar), for in-vitro fertilizationDevelopment of expression system and manufacturing process, supply of GMP bulk drug substance, worldwide exclusive license for Gedeon Richter
In-market (Bemfola®): EU, Norway, Albania, Iceland, Kosova, North Macedonia, Montenegro, Norway, Serbia, Ukraine, Australia, New Zealand, Israel, Kuwait, Saudia Arabia, UAE, Chile, Colombia, Curacao, Jamaica, Peru, Republic of Korea
Arwan Pharmaceutical Industries
Lebanon
Erythropoietin (biosimilar), stimulation of production of reticulocytesDevelopment of expression system and manufacturing process, supply of GMP bulk formulated drug product, regional license for Arwan
In-market (Alpeen®): Lebanon, Kenya, Lybia
Uvax Bio LLC
USA
HIV envelope protein as self-assembling nanoparticles, HIV vaccine candidateCell line and process development, production of GMP bulk drug substance and drug product for phase 1
Phase 1, Australia
EHVA, EU H2020 project
contract partner IAVI
USA
Two trimeric HIV envelope proteins established by University of Regensburg, HIV vaccine candidatesCell line and process development, production of GMP bulk drug substance and drug product for phase 1
Preclinical
Apeiron Biologics AG
(before for GSK) Austria
Recombinant human soluble angiotensin converting enzyme 2 (ACE2), therapy of COVID-19 as well as various diseases with an imbalance of the renin angiotensin systemProcess development, production of GMP bulk drug substance and drug product
Phase 2, USA, Canada & Europe
SurgiMab SAS
France
SGM-101, antibody conjugated to near-infrared fluorochrome, detection of cancer during surgery for colorectal cancer or pancreatic cancerOptimization of manufacturing process for antibody production and conjugation, production of GMP bulk drug substance as well as drug product for clinical studies
Phase 3 ongoing, Europe & US
EAVI2020
EU H2020 project coordinated by Imperial College London
UK
Eight trimeric HIV envelope proteins, HIV vaccineCell line and process development, production of GMP bulk drug substance as well as drug product for phase 1
Phase 0, UK; Phase 1, the Netherlands; Phase 1, Spain
Netris Pharma
France
Humanised anti-Netrin-1 monoclonal antibody, treatment of cancerCell line and process development, production of GMP bulk drug substance as well as drug product for phase 1/2
Phase 1b/2 ongoing, Europe
GeNeuro SA
Switzerland/France
GNbAC1, humanized monoclonal IgG4, treatment of multiple sclerosisCell line and process development, production of GMP bulk drug substance as well as drug product for phase 1/2
Phase 2, Europe & Australia
Fides SA
Italy
Human monoclonal IgG1, treatment of Hepatitis C virus (HCV) infectionProcess development, production of GMP bulk drug substance as well as drug product for phase 1/2
Preclinical
Takeda (former Baxter AG)
Austria
Murine monoclonal antibody HPC-4, affinity purification of protein C (Ceprotin®)GMP production of bulk material, preparation of affinity chromatography gel
In-market (Ceprotin®): EU, Australia, Kuwait, Oman, Qatar, Russia, Saudia Arabia, South Africa, South Korea, Switzerland, Turkey, UAE, UK, US
CCRI Vienna / Apeiron Biologics AG
Austria
Chimeric monoclonal IgG1 against GD2, treatment of neuroblastomaDevelopment of expression system and manufacturing process, production of GMP bulk drug substance for clinical studies
In-market (Dinutuximab beta, EUSA Pharma Ltd)

CUSTOMER/PARTNER

Gedeon Richter
Hungary

PRODUCT

rhFSH (biosimilar), for in-vitro fertilization

SCOPE AT POLYMUN

Development of expression system and manufacturing process, supply of GMP bulk drug substance, worldwide exclusive license for Gedeon Richter

STATUS

In-market (Bemfola®): EU, Norway, Albania, Iceland, Kosova, North Macedonia, Montenegro, Norway, Serbia, Ukraine, Australia, New Zealand, Israel, Kuwait, Saudia Arabia, UAE, Chile, Colombia, Curacao, Jamaica, Peru, Republic of Korea

CUSTOMER/PARTNER

Arwan Pharmaceutical Industries
Lebanon

PRODUCT

Erythropoietin (biosimilar), stimulation of production of reticulocytes

SCOPE AT POLYMUN

Development of expression system and manufacturing process, supply of GMP bulk formulated drug product, regional license for Arwan

STATUS

In-market (Alpeen®): Lebanon, Kenya, Lybia

CUSTOMER/PARTNER

Uvax Bio LLC
USA

PRODUCT

HIV envelope protein as self-assembling nanoparticles, HIV vaccine candidate

SCOPE AT POLYMUN

Cell line and process development, production of GMP bulk drug substance and drug product for phase 1

STATUS

Phase 1, Australia

CUSTOMER/PARTNER

EHVA, EU H2020 project
contract partner IAVI
USA

PRODUCT

Two trimeric HIV envelope proteins established by University of Regensburg, HIV vaccine candidates

SCOPE AT POLYMUN

Cell line and process development, production of GMP bulk drug substance and drug product for phase 1

STATUS

Preclinical

CUSTOMER/PARTNER

Apeiron Biologics AG
(before for GSK) Austria

PRODUCT

Recombinant human soluble angiotensin converting enzyme 2 (ACE2), therapy of COVID-19 as well as various diseases with an imbalance of the renin angiotensin system

SCOPE AT POLYMUN

Process development, production of GMP bulk drug substance and drug product

STATUS

Phase 2, USA, Canada & Europe

CUSTOMER/PARTNER

SurgiMab SAS
France

PRODUCT

SGM-101, antibody conjugated to near-infrared fluorochrome, detection of cancer during surgery for colorectal cancer or pancreatic cancer

SCOPE AT POLYMUN

Optimization of manufacturing process for antibody production and conjugation, production of GMP bulk drug substance as well as drug product for clinical studies

STATUS

Phase 3 ongoing, Europe & US

CUSTOMER/PARTNER

EAVI2020
EU H2020 project coordinated by Imperial College London
UK

PRODUCT

Eight trimeric HIV envelope proteins, HIV vaccine

SCOPE AT POLYMUN

Cell line and process development, production of GMP bulk drug substance as well as drug product for phase 1

STATUS

Phase 0, UK; Phase 1, the Netherlands; Phase 1, Spain

CUSTOMER/PARTNER

Netris Pharma
France

PRODUCT

Humanised anti-Netrin-1 monoclonal antibody, treatment of cancer

SCOPE AT POLYMUN

Cell line and process development, production of GMP bulk drug substance as well as drug product for phase 1/2

STATUS

Phase 1b/2 ongoing, Europe

CUSTOMER/PARTNER

GeNeuro SA
Switzerland/France

PRODUCT

GNbAC1, humanized monoclonal IgG4, treatment of multiple sclerosis

SCOPE AT POLYMUN

Cell line and process development, production of GMP bulk drug substance as well as drug product for phase 1/2

STATUS

Phase 2, Europe & Australia

CUSTOMER/PARTNER

Fides SA
Italy

PRODUCT

Human monoclonal IgG1, treatment of Hepatitis C virus (HCV) infection

SCOPE AT POLYMUN

Process development, production of GMP bulk drug substance as well as drug product for phase 1/2

STATUS

Preclinical

CUSTOMER/PARTNER

Takeda (former Baxter AG)
Austria

PRODUCT

Murine monoclonal antibody HPC-4, affinity purification of protein C (Ceprotin®)

SCOPE AT POLYMUN

GMP production of bulk material, preparation of affinity chromatography gel

STATUS

In-market (Ceprotin®): EU, Australia, Kuwait, Oman, Qatar, Russia, Saudia Arabia, South Africa, South Korea, Switzerland, Turkey, UAE, UK, US

CUSTOMER/PARTNER

CCRI Vienna / Apeiron Biologics AG
Austria

PRODUCT

Chimeric monoclonal IgG1 against GD2, treatment of neuroblastoma

SCOPE AT POLYMUN

Development of expression system and manufacturing process, production of GMP bulk drug substance for clinical studies

STATUS

In-market (Dinutuximab beta, EUSA Pharma Ltd)