Built for Biologics
Aseptic GMP fill-finish and lyophilization
services for clinical-stage drug products
Built for Biologics
Aseptic GMP fill-finish and lyophilization services for clinical-stage
drug products
At Archivel, we combine deep expertise in complex biologics with the agility of a specialized CDMO. We support programs from pre-clinical through clinical stages, manufacturing GMP and non-GMP batches for biotech companies and translational researchers who need a partner with genuine technical depth and regulatory readiness. From formulation development to aseptic fill-finish and lyophilization, we deliver tailored solutions built around the specific demands of your program — handling the complexity so you can focus on your science.
Your Partner in Product Development
- 100+ m2 of GMP Facilities
- Expert Team
- Agile, Flexible, Tailored solutions
Biological products
- Vaccines
- Oncologic vaccines
- Peptide and Proteins
- Antibodies
- Cell-derived products
- Innovative products
From the lab,
to the clinic
- R&D
- Process scale-up
- GMP manufacturing
- Clinical Batch release
With Quality
Manufacturing authorized since 2010 (MIA 1132)
OUR SERVICES
Our CDMO Services for Biological Drug Products
We bring together scientific expertise, state-of-the-art aseptic manufacturing, and rigorous GMP standards to support your biological drug product from pre-clinical through the clinic.
Drug Product Development
We translate biologics and immunotherapeutic molecules into robust, manufacturable formulations, integrating lyophilization process design from day one, at the clinical scale your project needs.
Fill & Finish
Aseptic filling of sterile liquids — including injectables and ophthalmic products — across all primary container formats under Grade A/B cleanroom conditions, with terminal sterilization also available.
Lyophilization
Clinical-scale freeze-drying under GMP conditions, covering full cycle development and batch production. We adapt to your starting point — working from an existing formulation or developing one in-house.
Analytical Services & Batch Release
Integrated analytical services supporting clinical development, including method development and validation, biological, physicochemical and microbiological testing, in-process controls, release testing, certification, and clinical batch reléase folowwing in-house packaging and relabelling.
Storage & Distribution
GMP-compliant storage of investigational medicinal products until shipment, followed by coordinated distribution to clinical trial sites worldwide. Temperature-controlled logistics are managed throughout the supply chain to ensure product integrity and on-time delivery.
BUILT ON QUALITY
Facilities and Quality Certificates
Located in Barcelona, one of Europe’s leading regions for clinical research and trial activity, our 720 m² facility brings together GMP production, analytical QC, and controlled storage under one roof, designed to support biologics and immunotherapeutic products from development through clinical batch release.
Our facilities include:
Aseptic GMP Manufacturing (Annex I)
– 37m² Grade C and 33 m² Grade B cleanrooms with oRABS and Grade A unidirectional flow for aseptic processing and sterile drug product manufacturing.
– Lyophilization integrated within the aseptic suite, supporting development through GMP batch manufacturing.
– Terminal sterilization also available.
GMP QC Laboratory
75 m² GMP analytical laboratory ensuring every batch meets the highest safety, identity, purity, and potency standards prior to release.
BSL-3 Containment (Annex II)
36 m² Grade B biocontainment room certified for Group 3 biological agents, supporting special drug substance manufacturing projects.
BSL-2 & GMO Laboratory
Dedicated 25 m² containment laboratory designed for the safe and compliant handling of viral vectors and genetically.
News
Archivel Farma renews GMP certification and strengthens its transformation into a CDMO
RUTI® in combination with BCG Therapy Show Encouraging Outcomes in Bladder Cancer
RUTI® in combination with BCG Therapy Show Encouraging Outcomes in Bladder Cancer
Joint Efforts in Tuberculosis Research: TB Alliance Visits Archivel
