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/PARTNER | PRODUCT | SCOPE AT POLYMUN | STATUS |
---|---|---|---|
Gedeon Richter Hungary | rhFSH (biosimilar), for in-vitro fertilization | Development 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 reticulocytes | Development 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 candidate | Cell 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 candidates | Cell 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 system | Process 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 cancer | Optimization 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 vaccine | Cell 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 cancer | Cell 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 sclerosis | Cell 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) infection | Process 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 neuroblastoma | Development 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 RichterHungary
PRODUCT
rhFSH (biosimilar), for in-vitro fertilizationSCOPE AT POLYMUN
Development of expression system and manufacturing process, supply of GMP bulk drug substance, worldwide exclusive license for Gedeon RichterSTATUS
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 IndustriesLebanon
PRODUCT
Erythropoietin (biosimilar), stimulation of production of reticulocytesSCOPE AT POLYMUN
Development of expression system and manufacturing process, supply of GMP bulk formulated drug product, regional license for ArwanSTATUS
In-market (Alpeen®): Lebanon, Kenya, Lybia
CUSTOMER/PARTNER
Uvax Bio LLCUSA
PRODUCT
HIV envelope protein as self-assembling nanoparticles, HIV vaccine candidateSCOPE AT POLYMUN
Cell line and process development, production of GMP bulk drug substance and drug product for phase 1STATUS
Phase 1, Australia
PRODUCT
Two trimeric HIV envelope proteins established by University of Regensburg, HIV vaccine candidatesSCOPE AT POLYMUN
Cell line and process development, production of GMP bulk drug substance and drug product for phase 1STATUS
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 systemSCOPE AT POLYMUN
Process development, production of GMP bulk drug substance and drug productSTATUS
Phase 2, USA, Canada & Europe
CUSTOMER/PARTNER
SurgiMab SASFrance
PRODUCT
SGM-101, antibody conjugated to near-infrared fluorochrome, detection of cancer during surgery for colorectal cancer or pancreatic cancerSCOPE AT POLYMUN
Optimization of manufacturing process for antibody production and conjugation, production of GMP bulk drug substance as well as drug product for clinical studiesSTATUS
Phase 3 ongoing, Europe & US
PRODUCT
Eight trimeric HIV envelope proteins, HIV vaccineSCOPE AT POLYMUN
Cell line and process development, production of GMP bulk drug substance as well as drug product for phase 1STATUS
Phase 0, UK; Phase 1, the Netherlands; Phase 1, Spain
CUSTOMER/PARTNER
Netris PharmaFrance
PRODUCT
Humanised anti-Netrin-1 monoclonal antibody, treatment of cancerSCOPE AT POLYMUN
Cell line and process development, production of GMP bulk drug substance as well as drug product for phase 1/2STATUS
Phase 1b/2 ongoing, Europe
CUSTOMER/PARTNER
GeNeuro SASwitzerland/France
PRODUCT
GNbAC1, humanized monoclonal IgG4, treatment of multiple sclerosisSCOPE AT POLYMUN
Cell line and process development, production of GMP bulk drug substance as well as drug product for phase 1/2STATUS
Phase 2, Europe & Australia
CUSTOMER/PARTNER
Fides SAItaly
PRODUCT
Human monoclonal IgG1, treatment of Hepatitis C virus (HCV) infectionSCOPE AT POLYMUN
Process development, production of GMP bulk drug substance as well as drug product for phase 1/2STATUS
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 gelSTATUS
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 AGAustria
PRODUCT
Chimeric monoclonal IgG1 against GD2, treatment of neuroblastomaSCOPE AT POLYMUN
Development of expression system and manufacturing process, production of GMP bulk drug substance for clinical studiesSTATUS
In-market (Dinutuximab beta, EUSA Pharma Ltd)