Investigational and Medicinal Products Plant

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):
• 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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