Manufacturing of biopharmaceutical active ingredients: recombinant proteins, peptides, monoclonal antibodies, PEGylation and analytics.
Helvetic BioPharma S.A.
Mezzovico (CH)New on Amplifa
About Helvetic BioPharma
Helvetic BioPharma is a biopharmaceutical company based in Mezzovico in the canton of Ticino, Switzerland, specialized in the manufacturing of high-quality biological products and active pharmaceutical ingredients (APIs). The technology portfolio comprises recombinant proteins such as erythropoietin (EPO) and filgrastim (G-CSF), PEGylated molecules, synthetic peptides, fertility hormones and monoclonal antibodies. The company offers CMO services with mammalian cell culture and microbial fermentation, and since 2024 also upstream production and fill-and-finish. The QC laboratories of around 300 m² perform analyses in accordance with GMP, GLP and ICH guidelines, including HPLC, electrophoresis, immunoassays, real-time PCR, endotoxin and sterility testing. Founded in 2015, the company has been GMP-certified by Swissmedic since 2021 and is located in the Mezzovico industrial park near Lugano with around 3000 m² of production, laboratory and office space. Therapeutic focus areas are oncology, hematology, immuno-modulation, autoimmune diseases and fertility.
- Site
- Mezzovico
- Processes
- Mammalian cell culture, Microbial fermentation, PEGylation (chemical modification of therapeutic proteins), Manufacturing of recombinant proteins, Manufacturing of synthetic peptides, Manufacturing of monoclonal antibodies, Upstream production, Fill-and-Finish
- Materials
- Recombinant proteins (e.g. erythropoietin/EPO, filgrastim/G-CSF, PEG-G-CSF, PEG-EPO, fertility, Synthetic peptides, Monoclonal antibodies, Erythropoietin (EPO) / PEG-EPO, Filgrastim (G-CSF) / PEG-G-CSF, Fertility Hormones, Synthetic Peptides, Monoclonal Antibodies
- Certificates
- GMP certification, GMP (Swissmedic)
- Founded
- 2015
- Industries
- Biopharmaceuticals, Pharmaceuticals
- 01
Research & Development
- 02
Cell culture / fermentation (upstream)
- 03
PEGylation / chemical modification
- 04
Purification
- 05
Fill-and-Finish
- 06
Quality control and release
Products and Technologies
Erythropoietin (EPO) / PEG-EPO
Recombinant protein for the treatment of anemia, also available as a long-acting PEGylated form.
Filgrastim (G-CSF) / PEG-G-CSF
Recombinant protein to support leukocyte formation, in production since 2022.
Fertility Hormones
Hormonal active ingredients for the fertility sector.
Synthetic Peptides
Peptide active ingredients for therapeutic applications.
Monoclonal Antibodies
Manufacturing of therapeutic antibodies on the company's own technology platform.
Site
Mezzovico
CHAPI production, laboratory, warehouse, administration
- Materials
- Recombinant proteins, peptides, monoclonal antibodies
- Mammalian cell culture
- Microbial fermentation
- PEGylation
- HPLC
- Electrophoresis
- Real-time PCR
- Fill-and-Finish (from 2024)
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Mammalian cell cultureBiotechnology/CMO | – | – | – | – | – |
| Microbial fermentationBiotechnology/CMO | – | – | – | – | – |
| PEGylation (chemical modification of therapeutic proteins)Biotechnology | – | – | – | – | – |
| Manufacturing of recombinant proteinsBiotechnology | – | – | – | – | – |
| Manufacturing of synthetic peptidesBiotechnology | – | – | – | – | – |
| Manufacturing of monoclonal antibodiesBiotechnology | – | – | – | – | – |
| Upstream productionBiotechnology | – | – | – | – | – |
| Fill-and-FinishBiotechnology | – | – | – | – | – |
| G-CSF manufacturingBiotechnology | – | – | – | – | – |
| HPLCTesting | – | – | – | – | – |
| ElectrophoresisTesting | – | – | – | – | – |
| Immuno-enzymatic assays (ELISA)Testing | – | – | – | – | – |
| Real-time PCRTesting | – | – | – | – | – |
| Bacterial endotoxin testingTesting | – | – | – | – | – |
| Microbial limit testingTesting | – | – | – | – | – |
| Sterility testingTesting | – | – | – | – | – |
Additional services
Quality and Analytics
The company is fully GMP-compliant and certified by Swissmedic for the manufacture of and trade in pharmaceutical products. The QC laboratories (approx. 300 m²) operate in accordance with GMP, GLP and ICH guidelines using state-of-the-art analytics such as HPLC, electrophoresis, ELISA, real-time PCR, endotoxin, sterility and microbiology testing.
| Evidence | Mezzovico |
|---|---|
| GMP (Swissmedic) |
Milestones
- 2015
Founding of Helvetic BioPharma
- 2020
Completion of the API production facility
- 2021
GMP approval by Swissmedic
- 1Q 2022
Start of G-CSF production
- 3Q 2022
Start of PEG-G-CSF production and start of construction of the upstream and fill-and-finish area
- 3Q 2024
Start of upstream and fill-and-finish activities