Large Scale Plant Portugal

Large Scale Plant Portugal

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.

For now, 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 room with each filling room

 

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Certifications

• ISO
• EMA (EU GMP)
• World Health Organization (GMP / HACCP)

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Activity

• Cell therapy derivatives / Secretomes, Abs (Antibodies), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Phase II, Phase III, Human
• Toxicity (OEB classification):
• 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)

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Batch Size / Reactor

• Medium, Large, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L

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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, Clean room rental, 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

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