Fill & Finish

Executive Summary

• Our rich portfolio of manufacturing services includes Fill & Finish of the final drug product, either as a continuation of the integrated manufacturing service or as a separate stand-alone order. Fill & Finish entails all elements necessary to obtain a complete biologic drug product, including vials sterilization, filling, stoppering and capping in sterile conditions, product inspection, secondary packaging and serialization.
• Mabion possesses top-notch equipment and well-tested procedures to assure precise filling, sterile conditions and high quality of the manufactured drug product. Fully automated isolator-based filling line along with the disposables system for dosing needles allows us to achieve efficiency of 6000 vials per hour (for 10 ml vials).
• We can adjust our filling line and other devices to many different vial formats, spanning from 2 to 100 ml. Our extensive manufacturing experience includes large-scale production of drug product for two international Phase III clinical trials of rituximab biosimilar, which together enrolled nearly 1000 patients.
• In addition to customary Fill & Finish services, our large facilities are capable of long-term GMP-compliant storage of the produced drug vials as well as GDP-compliant transport to the desired localizations all over the Europe. These services include storage and transport under ultra-low and low temperature conditions.

Sterilization

Assuring sterility of the Fill & Finish process is a highly important, but at the same time highly complex issue that requires purpose-built facilities, specialized equipment and, most of all, careful execution by skilled and experienced staff. All these factors are met at Mabion, ensuring safe and GMP-compliant environment for biologic drugs’ production.
Sterilization capabilities at Mabion are summarized in the table below.

Product Inspection

Final quality testing of the manufactured drug product is essential to secure patients’ safety. Product inspection at Mabion includes manual or automatic leak detection and visual inspection, with capacity of 6000 cph. Automatic inspection is done for 100% of the produced containers.

Packaging and Serialization

Mabion’s offer includes secondary packaging, labelling and serialization of the finished drug product (vials for i.v. use). Detailed overview of the packaging parameters is provided in the table below.

Storage and Transport

Drug products manufactured at Mabion can be stored for a long period of time in our GMP-compliant warehouses. This includes storage in a cold room, at a temperature of 2ºC – 8ºC and below -60ºC.

Products can be also delivered to any desired destination in Europe by our well-equipped and experienced Logistics team. Transport is performed under controlled conditions within four temperature ranges (see below). The temperature data are continuously monitored and recorded, in accordance with the GDP principles. The use of innovative solutions protects the shipment from temperature deviations.

Our Logistics unit is also capable of planning the entire supply chain for the purpose of clinical research as well as commercial distribution.

Temperature ranges available in Mabion for the transport of pharmaceutical goods