Portugal Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe
Commercial Scale Facility
About the plant
Manufacturing
Upstream
Culture process in flasks
Biological security chamber
Stainless-steel bioreactors:
- 1 x 100 L
- 1 x 300 L
- 2 x 2500 L
Media preparation
Stainless-steel bioreactors:
- 1 x 300 L
- 1 x 800 L
- 2 x 3000 L
Downstream and purification
Our facilities are prepared to receive and install any kind of equipment.
Currently, the Downstream area has 6 stainless-steel bioreactors, a room prepared for chromatography and purification processes, and two +4°C chambers.
Fill & Finish
1 filling line: IMA machine
- Vial washing machine
- Filling machine loading
- Capacity for 2R vials: 24,000 vials/hour
- Possibility of adding other vial sizes
- Final washing machine
1 lyophilizer: IMA machine (capacity to add another lyophilizer)
- Automatic lyophilizer with capacity of up to 180,000 vials per run
Storage: (+2 - +8°C), (-20°C) and (-80°C)
2 double-door autoclaves connecting the washing and depyrogenation tunnels with each filling room
Certifications
- ISO
- EMA (EU GMP)
- World Health Organization (GMP / HACCP)
Activity
- Cell therapy derivatives / Secretomes, Abs (Antibodies), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, Injectables, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, BIOLOGICS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Phase II, Phase III, Human
- Toxicity (OEB classification): N/A
- DEA: N/A
- BSL: 1, 2
- Therapeutic areas: (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (R) Respiratory system
- Markets: EMA (EU)
Batch Size / Reactor
- Medium, Large, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, Comparability studies, Genetic analysis & Pharmacogenetics, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, 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
