Spain Europe
BIOLOGICS OLIGONUCLEOTIDES in Europe
Aseptic fill-finish and lyophilization for clinical-stage drug products.
About the plant
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.
Key capabilities:
- Aseptic processing (Annex I): Grade C/B cleanrooms with oRABS and Grade A unidirectional airflow, for sterile liquid filling and freeze-dried product manufacturing. Terminal sterilization available.
- Lyophilization: Lyobeta 20 freeze-dryer, covering cycle development through GMP batch production.
- GMP BSL-3 biocontainment: 36 m² Grade B facility for Group 3 biological agents — one of few GMP-certified BSL-3 suites available to external partners in Europe.
- BSL-2 & GMO: Dedicated space for viral vector and GMO-based biologics, with the regulatory framework to match.
- GMP QC analytical laboratory: Full in-house QC capabilities ensuring every batch meets safety, identity, purity, and potency standards before release.
Compliance
- ICH
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- World Health Organization (GMP / HACCP)
- ANMAT (Argentina nueva GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- 9001
- ICHQ3A
- ICHQ3B
- ICHQ3D
- ICHQ1A
Activity
- Cell therapy derivatives / Secretomes, Abs (Antibodies), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, BIOLOGICS manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
- Controlled substance: N/A
- BSL: 1, 2, 3
- Therapeutic areas: N/A
- Markets: N/A
Batch Size / Reactor
- Small, Medium
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Clean room rental, R&D, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Downstream, Fill&Finish, Sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, Extractables & Leachables, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL), Microbiology, Drug Product – Liquid
