CZ Vaccines | Investigational and Medicinal Products Plant

CZ Vaccines | Investigational and Medicinal Products Plant

Clinical Trials Facility

About the plant

Upstream and downstream capabilities at small scale with flexibility for different capacities.

Ultrafiltration and diafiltration

Chromatography (ÄKTA ready)

Filling & freeze-drying capacities

 

2R vials (possibility of adding other vial sizes)

 

1 Lyophilizer

Storage (+2° - +8°C), (-20°C), (-30°C) and (-80°C)

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Certifications

• ISO
• EMA (EU GMP)
• World Health Organization (GMP / HACCP)
• ANVISA (Brazil B-GMP)

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Activity

• Cell therapy derivatives / Secretomes, Peptide, protein, hormone & enzyme, Vaccines, LBP (Live Biotherapeutic Products), ATMP (Advanced Therapies), Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, BIOLOGICS manufacturing

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Features

• Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): N/A
• DEA: N/A
• BSL: 2
• Therapeutic areas: (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (R) Respiratory system
• Markets: EMA (EU), CDSCO (India), ANVISA (Brazil)

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Batch Size / Reactor

• Small, Batch, 1 - 100 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, Comparability studies, 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, 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, Storage, Distribution

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