VIVUNT is a pharmaceutical company within VIRIXENE, an international group dedicated to the development, production, and commercialization of medicines. We provide comprehensive services from development to commercial manufacturing, with a strong focus on quality, operational efficiency, and regulatory compliance. Our experience and technology accelerate market access for safe, high-impact therapies. Our state-of-the-art manufacturing site is dedicated to sterile oncology drugs, both in liquid and lyophilized vials, and complies with international GMP standards and EMA Annex 1 quality standards.

Technology:

– Dosage forms: Liquid vials and lyophilized vials.
– 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 m² 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.

Type of Drugs Manufactured:

Small Molecule

CDMO Services:

Drug Product Formulation (FDF)

No. of Manufacturing Facilities:

3-5

High Potent Products capabilities:

OEB 3;OEB 4-5;OEB >5

Facilities Locations:

Europe

Regulatory Approvals for facilities:

EMA (Europe)

Manufacturing Technologies:

Liquid and lyophilized vials

Current Capacity:

Vivunt Pharma is committed to delivering high-quality services to meet the diverse needs of their clients in the pharmaceutical sector. For more information, please visit vivunt.es.