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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®): Europe, Australia, New Zealand, Israel & MENA
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
First clinical studies started, Europe
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 1 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®): 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 for clinical studies
In-market (Dinutuximab beta Apeiron): Europe

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®): Europe, Australia, New Zealand, Israel & MENA

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

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

First clinical studies started, Europe

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 1 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®): 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 for clinical studies

STATUS

In-market (Dinutuximab beta Apeiron): Europe