Gipharma cGMP Filling and Lyophilization services

Gipharma possesses leading edge experience and capabilities, as well as AIFA’s authorization for the manufacture of sterile injectable drug products, ranging between small volume liquids, either aseptically filled or terminally sterilized, and lyophilized products.The modern Gipharma production site is cGMP certified for manufacture of investigational medicinal products (IMPs) and commercial products.

These include oxygen-sensitive products, like radiopharmaceuticals in which Gipharma has near-unrivalled experience, as well as biologicals and biotechnologicals.

Authorized Manufacturing Operations

Gipharma’s range of sterile injectable drug products include:

• Aseptically prepared lyophilisates
• Aseptically prepared small volume liquids
• Terminally sterilized small volume liquids

Gipharma’s portfolio of biological medicinal products include:

• Blood products
• Human or animal extracted products
• Biotechnology products, for IMP purpose

Sterile Small Volume Liquids

Gipharma currently manufactures injectable solutions in small vial format (up to 100 ml size) with a capacity up to 30.000 vials per day.

Sterile Lyophilisates

Gipharma manufactures a wide range of injectable lyophilized drug products, with a batch size up to 13.000 vials.

Radiopharmaceutical Cold Kits
Gipharma holds a specific authorization to produce cold kits, which are freeze-dried compounds intended for use in Nuclear Medicine, upon reconstitution at end user side with a labelling solution containing a radioactive isotope.

Other services for Nuclear Medicine

Gipharma is able to support the Positron Emission Tomography (PET) centers with a complete range of cGMP-compliant services, such as:

• Supply of Sterile Evacuated Vials
• Supply of sterile saline solutions

Quality Control Testing, including radioactive compounds

• Sterility
• Bioburden
• Media fill, including their supply
• Radionuclidic purity

Resources

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