Automated compounding systems for the non-sterile manufacture of personalized medicines in pharmacies
CurifyLabs Oy
Helsinki (FI) · Bad Laer (DE) · Jacksonville, FL (US)New on Amplifa
About CurifyLabs
CurifyLabs is a healthtech company developing solutions for automated non-sterile compounding in pharmacies and hospital pharmacies. The Compounding System Solution (CSS) combines GMP-manufactured CuraBlend® excipient bases, 3D-printing-inspired compounding robotics (PharmaPrinter Aurum), integrated in-process quality control, compliance software with a Formulation Library and digital batch records into a connected end-to-end system. The workflows support USP <795>-compliant non-sterile compounding practice as well as requirements under 21 CFR Part 11 and EU Annex 11; development was carried out in accordance with ISO 13485. The offering also includes formulation development (CurifyLabs Create), stability data, automated labeling, heat-sealed blister packaging as well as support and care plans. The system is in clinical use at customers in Europe and the USA, including hospital pharmacies and compounding pharmacies. Founded in 2021 by Charlotta Topelius and Niklas Sandler, the company has locations in Helsinki, Bad Laer (Germany) and Jacksonville, Florida.
- Site
- Helsinki
- Processes
- Automated non-sterile compounding manufacture (Compounding System Solution, CSS), Compounding with 3D-printing-inspired robotics (PharmaPrinter Aurum), Heat-sealed blister packaging (reduces moisture and oxygen exposure), Automated unit-level labeling linked to batch records, Integrated in-process quality control (QC) and digital batch records, Automated non-sterile compounding solution (Compounding System Solution, CSS), Compounding hardware/robotics (PharmaPrinter Aurum, 3D-printing-inspired), Compliance software with Formulation Library and digital batch records
- Materials
- CuraBlend® excipient bases (GMP-grade), CuraBlend® Excipient Bases (GMP-grade), Compounding System Solution (CSS), PharmaPrinter Aurum
- Certificates
- ISO 13485 (development in accordance with), Development in accordance with ISO 13485, USP <795>-compliant workflows, 21 CFR Part 11 / EU Annex 11
- Founded
- 2021
- Industries
- Pharmacies (community and hospital pharmacies), Personalized Medicine, Healthcare / Healthtech
- 01
Formulation design (CurifyLabs Create / Formulation Library)
- 02
GMP-manufactured CuraBlend® excipient bases
- 03
Automated non-sterile compounding (CSS, PharmaPrinter Aurum)
- 04
Integrated in-process quality control
- 05
Digital batch records and compliance documentation
- 06
Labeling and GMP-compliant packaging
- 07
Support / Care Plan
Excipient Bases & Technologies
CuraBlend® Excipient Bases (GMP-grade)
Validated excipient bases for multi-dosage-form compounding with stability data and Beyond-Use-Date documentation.
Compounding System Solution (CSS)
Modular, expandable automation system for non-sterile compounding in pharmacies.
PharmaPrinter Aurum
3D-printing-inspired compounding robotics for patient-specific drug preparations.
Locations
Helsinki
FIHeadquarters (CurifyLabs Oy)
- Materials
- CuraBlend® excipient bases
- Compounding System Solution (CSS)
- PharmaPrinter Aurum
Bad Laer
DEGerman branch office (CurifyLabs GmbH)
Jacksonville, FL
USUS office (CurifyLabs Inc.)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Automated non-sterile compounding manufacture (Compounding System Solution, CSS)Plastics | – | – | – | 5–10 prescriptions/day (ROI model) | CuraBlend® GMP-grade excipient bases |
| Compounding with 3D-printing-inspired robotics (PharmaPrinter Aurum)Additive | – | – | – | – | CuraBlend® GMP-grade excipient bases |
| Heat-sealed blister packaging (reduces moisture and oxygen exposure)Packaging | – | – | – | – | – |
| Automated unit-level labeling linked to batch recordsPackaging | – | – | – | – | – |
| Integrated in-process quality control (QC) and digital batch recordsTesting | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| PharmaPrinter Aurum (compounding robotics, 3D-printing-inspired) | CurifyLabs PharmaPrinter Aurum | – | – | – | Pharmacies and hospital pharmacies in Europe and the USA |
| Modular compounding system (CSS) with automation modules | CurifyLabs Compounding System Solution (CSS) | – | – | – | Pharmacies and hospital pharmacies |
Additional services
Reference customers
Quality & Compliance
The workflows support USP <795> and USP <800>, are compliant with 21 CFR Part 11 and EU Annex 11, and integrated in-process QC with digital batch records ensures traceability and audit readiness. System development was carried out in accordance with ISO 13485.
| Evidence | Helsinki |
|---|---|
| Development in accordance with ISO 13485 | |
| USP <795>-compliant workflows | |
| 21 CFR Part 11 / EU Annex 11 |
History
- 2021
CurifyLabs founded by Charlotta Topelius and Niklas Sandler.
- 2023
Award 'Hottest Startup in Europe 2023'
- 2026
$14M Series-A funding; Red Dot 'Best of the Best' for PharmaPrinter Aurum; EU-funded RoboPharma project.