Global CDMO for aseptic filling of sterile pharmaceuticals, lyophilization as well as semi-solid and liquid dosage forms
Adragos Pharma GmbH
Munich (headquarters) · Courroux (Jura) · Leipzig · Livron · Maisons-Alfort · Athens · Kawagoe · Barcelona · TokyoNew on Amplifa
About Adragos Pharma
Adragos Pharma is a globally active Contract Development and Manufacturing Organisation (CDMO) headquartered in Munich. The company develops and produces (bio)pharmaceutical drugs, including sterile-filled liquid and lyophilized products in vials, ampoules and pre-filled syringes as well as semi-solid preparations such as creams, gels and ointments, oral solutions, suspensions, tablets and suppositories. Its service portfolio includes formulation and lyophilization cycle development, clinical Phase I–III production from batches of 200–300 ml with no minimum batch size, commercial fill-and-finish production, technology transfer and scale-up, analytics/QC, stability studies according to ICH as well as primary and secondary packaging with serialization. Materials processed include peptides, biologics such as monoclonal antibodies, small molecules, sterile suspensions, ophthalmic products, controlled substances and highly potent APIs (HPAPI, OEB5). At the Courroux site (Jura, Switzerland), more than 110 employees work on 6,200 m² in EU-GMP-certified (Swissmedic) and FDA-registered aseptic sterile production; further production sites are located in Leipzig, Livron, Maisons-Alfort and Kawagoe, and the R&D site is in Athens.
- Site
- Munich
- Processes
- Aseptic manufacturing of sterile (bio)pharmaceutical products (lyophilized and liquid), Aseptic filling, Lyophilization (freeze-drying), Complex/aseptic formulation, Clinical production (Phase I, II, III) – GMP manufacturing, pilot lot, scale-up, Commercial production – fill & finish, Secondary packaging, labeling, serialization, visual inspection, Aseptic Process Simulation (APS)
- Materials
- Peptides, Biologics / mAbs, Small molecules, Sterile suspensions, Controlled substances / narcotics, Highly potent APIs (HPAPI), Semi-solid formulations (creams, gels, ointments, pastes), Non-sterile liquids
- Certificates
- EU-GMP (sterile production lyophilized/liquid), US-FDA, EU-GMP (Swissmedic)
- Founded
- 1999
- Employees
- more than 110 (site
- Industries
- (Bio)pharmaceutical industry, Biotechnology
- 01
Formulation development
- 02
Lyophilization cycle development
- 03
Analytical method development
- 04
Clinical production Phase I–III
- 05
Technology transfer & scale-up
- 06
Aseptic filling / lyophilization
- 07
Secondary packaging & serialization
- 08
QC release & stability studies
- 09
GMP storage & distribution
Product Groups & Processes
Lyophilized sterile products
Freeze-drying of sterile (bio)pharmaceutical products, lyophilizer with 3.5 m² area at the Jura site.
Sterile liquid products
Aseptic filling of liquid injectable formulations into vials, ampoules and pre-filled syringes.
Semi-solid preparations
Manufacture of creams, gels, ointments and healing pastes, batch sizes 15 to 1,250 liters (Leipzig).
Highly potent APIs (HPAPI)
Handling of highly potent active ingredients with OEL ≥ 0.5 µg/m³ (OEB5), R&D site Athens.
Controlled substances
Licensed handling of narcotics and small quantities of high-value APIs, e.g. at the Jura and Livron sites.
Biologics / mAbs
Aseptic filling of monoclonal antibodies and biologics, including the first clinical batch for Igyxos (2021).
Sites
Courroux (Jura)
CHProduction site / CDMO for aseptic sterile production (lyophilized & liquid), clinical and small commercial
- Part weight / size
- clinical batches from 200–300 ml bulk, no
- Lot size
- Prototype, small series, medium series
- Materials
- Lyophilized & liquid sterile products, peptides, biologics, controlled substances
- Lyophilizer (3.5 m²)
- Isolators for sterility testing
Munich
DEHeadquarters
Athens
GRR&D site for Value Added Medicines, HPAPI capabilities (>3,000 m²)
- Materials
- HPAPI
Leipzig
DEProduction site for semi-solid and non-sterile liquid pharmaceuticals, >100 years of experience
- Part weight / size
- Bottles up to 1,000 ml (semi-automatic), up to 250 ml
- Lot size
- Medium series, large series
- Materials
- Creams, gels, ointments, non-sterile liquids
- Semi-automatic filling line Würschum (up to 10 bottles/min)
- Fully automatic aseptic filling line Groninger (up to 90 bottles/min, inertization)
- 5 filling lines (3 liquid, 2 semi-solid)
- Mixing vessels & homogenizers (15–1,250 l)
- HPLC/UPLC, GC, GC headspace, UV-VIS, titration
Livron
FRProduction site for sterile liquids and suppositories, >100 years of experience
- Part weight / size
- Ampoules 1–20 ml
- Lot size
- Medium series, large series
- Materials
- Sterile liquids, aqueous & oily solutions, cold-chain products
- New aseptic filling line 'Project FUTURE' (€12.7 million, RABS, robotics, >150 million ampoules/year)
Maisons-Alfort
FRProduction site for pre-filled syringes
- Lot size
- Medium series, large series
- Materials
- Sterile injectables, pre-filled syringes
- 2 filling lines for pre-filled syringes (RABS, up to 540 syringes/min)
Kawagoe
JPProduction site for ampoules, tablets and visual inspection, large cold-storage warehouse
- Materials
- Tablets, ampoules
Barcelona
ESRegional Office
Tokyo
JPRegional Office
Services & Dosage Forms
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Aseptic manufacturing of sterile (bio)pharmaceutical products (lyophilized and liquid)Engineering | – | – | – | – | Liquid pharmaceutical products, Lyophilized products, Peptides, Biological products, Controlled substances, Small molecules, Sterile suspensions, Ophthalmic products, Placebos/diluents |
| Aseptic fillingAssembly | – | – | – | no minimum lot size | Liquid pharmaceutical products |
| Lyophilization (freeze-drying)Engineering | – | – | – | – | Sterile pharmaceutical products |
| Complex/aseptic formulationEngineering | – | – | – | – | Peptides, Biological products, Controlled substances, Small molecules, Sterile suspensions, Ophthalmic products, Placebos/diluents |
| Clinical production (Phase I, II, III) – GMP manufacturing, pilot lot, scale-upEngineering | – | – | – | e.g. 200-300 ml bulk | Biopharmaceutical products |
| Commercial production – fill & finishAssembly | – | – | – | – | Sterile pharmaceutical products |
| Secondary packaging, labeling, serialization, visual inspectionAssembly | – | – | – | – | Pharmaceutical products |
| Aseptic Process Simulation (APS)Testing | – | – | – | – | – |
| Analytical services (HPLC-UV, UPLC-UV, particle counting, osmolality, Karl Fischer, UV-Vis, IR, pH)Testing | – | – | – | – | Pharmaceutical products |
| Stability studies (ICH conditions)Testing | – | – | – | – | Pharmaceutical products |
| Lyophilization cycle development, formulation development, filter/material compatibilityEngineering | – | – | – | – | Pharmaceutical products |
| Semi-automatic filling (Würschum line) – low to medium-viscosity products, bottles up to 1000Assembly | – | – | – | – | Low to medium-viscosity pharmaceutical solutions |
| Fully automatic filling (Groninger line) – aseptic, round bottles up to 250 ml, inertizationAssembly | – | – | – | – | Low to medium-viscosity pharmaceutical solutions |
| Manufacture of semi-solid pharmaceuticals (creams, gels, ointments)Assembly | – | – | – | 15 liters – 1250 liters | Creams, Gels, Ointments, Healing pastes |
| Manufacture of non-sterile liquid pharmaceuticalsAssembly | – | – | – | – | Non-sterile liquids |
| Aseptic filling of ampoules (Livron, Project FUTURE) – 1 ml to 20 ml, aqueous and oily solutionsAssembly | – | – | – | – | Aqueous solutions, Oily solutions, Cold-chain products, Gas-protected products |
| Aseptic filling of pre-filled syringes (Maisons-Alfort) – up to 540 syringes/minute, RABSAssembly | – | – | – | – | Sterile injectables |
| Manufacture of sterile liquids and suppositoriesAssembly | – | – | – | – | Sterile liquids, Suppositories |
| Tablet and ampoule manufacturingAssembly | – | – | – | – | Tablets, Ampoules |
| QC analytics Leipzig (HPLC, GC, GC headspace, UV-VIS, titration, microbiology TAMC/TYMC)Testing | – | – | – | – | APIs, Excipients, Semi-solids, Non-sterile liquids |
| Handling of highly potent APIs (HPAPI), OEL ≥ 0.5 µg/m³, OEB5Engineering | – | – | – | – | HPAPIs |
| Controlled substances / narcotics handlingEngineering | – | – | – | – | Controlled substances, Narcotics |
| Cold-chain management, GMP storage, distribution at controlled temperatureEngineering | – | – | – | – | Temperature-sensitive pharmaceutical products |
| Technology transfer and scale-up (sterile and semi-solid formulations)Engineering | – | – | – | – | Sterile injectables, Semi-solids |
9 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Lyophilizer | – | – | 3.5 m² | – | Jura (Courroux), Switzerland |
| Semi-automatic filling line (liquids) | Würschum Line | 1 | Bottles up to 1000 ml, up to 10 bottles/minute, almost any format | – | Leipzig, Germany |
| Fully automatic filling line (aseptic) | Groninger | 1 | Round bottles up to 250 ml, 6 filling stations, up to 90 bottles/minute, inertization | – | Leipzig, Germany |
| Filling lines (total, liquid and semi-solid) | – | 5 | 3 liquid, 2 semi-solid lines | – | Leipzig, Germany |
| New aseptic filling line (Project FUTURE) | – | 1 | Ampoules 1-20 ml, >150 million ampoules/year, robotics, RABS | – | Livron, France |
| Filling lines for pre-filled syringes | – | 2 | up to 540 syringes/minute, RABS environment | – | Maisons-Alfort, France |
| Semi-solid manufacturing equipment (mixing vessels, homogenizers) | – | – | Batch sizes 15 to 1250 liters | – | Leipzig, Germany |
| HPLC/UPLC, GC, GC headspace, UV-VIS, titration (analytics) | – | – | – | – | Leipzig, Germany |
| Isolators for sterility testing | – | – | – | – | Jura (Courroux), Switzerland |
Additional services
Reference customers
Quality & Approvals
Quality assurance follows a pharmaceutical quality system based on ICH Q10 with data integrity, CAPA management and risk-based processes. At the Jura site, QC analytics includes, among others, HPLC-UV/UPLC-UV, Karl Fischer water determination, endotoxin and sterility testing under isolator; in Leipzig, HPLC, GC/GC headspace, UV-VIS, titration and microbiology (TAMC/TYMC) are available.
| Evidence | Courroux (Jura) |
|---|---|
| EU-GMP (Swissmedic) | |
| US-FDA |
History
- 1999
Founding of the Jura site in Courroux, Switzerland
- 2021
First clinical mAb order from the biotechnology company Igyxos at the Jura site
- 2024
New Würschum and Groninger filling lines commissioned in Leipzig; new aseptic filling line 'Project FUTURE' in Livron (€12.7 million investment, >150 million ampoules/year)