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

Archivel is built on 20 years of experience delivering life-saving treatments to patients worldwide

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-certificationArchivelPress releaseArchivel Farma renews GMP certification and strengthens its transformation into a CDMO
20/01/2026

Archivel Farma renews GMP certification and strengthens its transformation into a CDMO

Archivel Farma announces that it has received the renewal of its GMP certification for manufacturing, confirming compliance with the requirements of the new Annex 1 to produce sterile and freeze-dried…
Archivel-Farma-Joint-Efforts-in-Tuberculosis-ResearchArchivelRUTI® in combination with BCG Therapy Show Encouraging Outcomes in Bladder Cancer
20/10/2025

RUTI® in combination with BCG Therapy Show Encouraging Outcomes in Bladder Cancer

Archivel Farma is delighted to anounce the outcome of RUTIVAC study in Bladder Cancer. The RUTI® vaccine, developed and produced in-house by Archivel Farma, was tested in a phase I…
Archivel-Farma-Joint-Efforts-in-Tuberculosis-ResearchArchivelJoint Efforts in Tuberculosis Research: TB Alliance Visits Archivel
02/08/2025

Joint Efforts in Tuberculosis Research: TB Alliance Visits Archivel

We were pleased to welcome Natalya Serbina, Senior Director at TB Alliance, to Archivel as part of our ongoing collaboration within the international Host Directed Therapy in Tuberculosis project. This…

Let's move your program forward

Whether you're in early R&D or preparing for your first clinical lot, our team is ready to discuss your needs and find the right solution for your program.