CZ Vaccines | Large Scale Plant Spain

CZ Vaccines | Large Scale Plant Spain

Single Use Commercial Scale Facility

About the plant

Manufacturing

Upstream

Cell and virus cultivation

Culture process in wave bioreactors

Single-use bioreactors:

• 2 x 50 L
• 3 x 200 L
• 3 x 2000 L

Blending mixer:

• Single-use tank 1 x 1500 L

Media preparation

Single-use mixers:

• 2 x 3000 L
• 2 x 2500 L
• 1 x 1000 L
• 2 x 650 L
• 1 x 200 L

Downstream and purification

Single-use mixers:

• 1 x 1500 L
• 1 x 650 L
• 1 x 500 L

Fill & Finish

Formulation and blending:

• 1 x 350 L single-use tanks
• 4 x 600 L stainless-steel tanks
• 1 x 3000 L single-use tank
• 4 x 6000 L stainless-steel tanks

2 filling lines: DARA machines

Capacity of each line based on vial size:

• Size 2R: 12,000 vials/hour
• Size 10R: 10,800 vials/hour
• Size 20R: 9,600 vials/hour

Automatic visual inspection: 2 x OPTREL machines

Storage: (+2 - +8°C), (-30°C) and (-80°C)

Combination of inhouse and subcontracted capacity for additional storage

2 double-door autoclaves connecting the washing and depyrogenation tunnels with each filling room

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Certifications

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

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Activity

• Abs (Antibodies), Peptide, protein, hormone & enzyme, Vaccines, Injectables, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), 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, (M) Musculoskeletal system, (N) Nervous system, (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, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, 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, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage

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