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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
Netris Pharma / EU-Project Hermione-2Man
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 1 ongoing, Europe
Finox AG
Switzerland
rhFSH (biosimilar), for in-vitro fertilizationDevelopment of expression system and manufacturing process, supply of GMP bulk drug substance, worldwide exclusive license for Finox
In-market (Bemfola®): Europe, Australia, New Zealand, Israel & MENA; Phase 3 onging, USA
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 2a ongoing, Australia, Phase 2b ongoing, Europe
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
GlaxoSmithKline
UK
Recombinant human soluble angiotensin converting enzyme 2 (ACE2), therapy of various diseases with an imbalance of the renin angiotensin systemProcess development, production of GMP bulk drug substance
Phase 2a ongoing, USA & Canada
Shire (former Baxter AG)
Austria
Murine monoclonal antibody HPC-4, affinity purification of protein C (Ceprotin®)GMP production of bulk material
In-market (Ceprotin®): Europe, 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
Phase 3, Europe, Israel & Australia
Baxter Innovation GmbH
Austria
OspA (Lyme Borreliosis vaccine)Fermentation of recombinant bacteria
Phase 1 completed, Europe

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 1 ongoing, Europe

CUSTOMER/PARTNER

Finox AG
Switzerland

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 Finox

STATUS

In-market (Bemfola®): Europe, Australia, New Zealand, Israel & MENA; Phase 3 onging, USA

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 2a ongoing, Australia, Phase 2b ongoing, Europe

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

GlaxoSmithKline
UK

PRODUCT

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

SCOPE AT POLYMUN

Process development, production of GMP bulk drug substance

STATUS

Phase 2a ongoing, USA & Canada

CUSTOMER/PARTNER

Shire (former Baxter AG)
Austria

PRODUCT

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

SCOPE AT POLYMUN

GMP production of bulk material

STATUS

In-market (Ceprotin®): Europe, 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

STATUS

Phase 3, Europe, Israel & Australia

CUSTOMER/PARTNER

Baxter Innovation GmbH
Austria

PRODUCT

OspA (Lyme Borreliosis vaccine)

SCOPE AT POLYMUN

Fermentation of recombinant bacteria

STATUS

Phase 1 completed, Europe