VIVUNT PHARMA

VIVUNT PHARMA

CDMO Sterile Oncology Drugs

About the plant

Manufacturing of Sterile Oncology Drugs

Liquid and lyophilized vials fully compliant with new Annex 1 EU GMP.

Location: León, Spain. Dosage forms: Liquid vials and lyophilized vials.

Fully compliant with Annex 1 EU GMP. Also, US FDA approval is expected for 2025. Isolators for raw materials sampling and dispensing and product manufacturing.

3 compounding vessels: 5, 20, and 300 liters. Batch sizes ranging from 3 to 1,200 liters, working under campaigns. Automated product filtration system with CIP, DIP & SIP. Filter integrity test incorporated.

High-speed filling line: 100 vials per minute / 6,000 vials per hour.

Full range of ISO formats from 4R to 100R.

Automated vial stoppering system under nitrogen atmosphere.

Lyophilizer with loading and unloading automated system, under Class A.

Maximum lyophilization capacity: 240 liters / 10 sqm surface.

Automated vial stoppering system inside the lyophilizer chamber under nitrogen atmosphere.

Automated in-process control (IPC).

• Class A & B continuous monitoring.
• Filling volume control by dynamic scale (100%).
• Leakage test by oxygen or electric arc determination (100%).
• Vial optical inspection (100%).

Manufacturing batches video recorded (100%).

Quality Control laboratory for API & FDF batch release and stability testing.

CCTV and interlocked doors security system with face recognition.

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Certifications

• EMA (EU GMP)

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Activity

• Injectables, Fill&Finish, Small volume vials, Large volume vials / Bottles, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: (L) Antineoplastic and immunomodulating agents
• Markets: EMA (EU)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Formulation mixing, Lyophilization, Research batches, Engineering batches, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization

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