Edition 2 / December 2018
On November 5th 2018, CordenPharma Caponago, located just outside Milan, Italy, proudly hosted an inauguration event to celebrate the opening of its new €20m Aseptic Fill & Finish suite for sterile injectable Drug Product manufacturing. Over 50 international guests were welcomed to the facility by CordenPharma Caponago Managing Director, Fabrizio Fiordigiglio and Global Injectable Platform Director, Fabio Stevanon. The full day program continued with key presentations from industry renowned guest speakers: Mark A. Chipperfield, Director & Principal Consultant at Corvus Device Consultancy, Fred Defesche, CEO of Beloteca and Jakob Gjelstrup Kristensen, VP of Commercial Manufacturing at Zealand Pharma.
Guests were given a guided tour of the ex-Astra Zeneca site that CordenPharma acquired in 2009. At that time the sole focus of the site was terminal sterilisation, primarily of the general anaesthetic Propofol. CordenPharma expanded its parenteral capabilities in 2015 by building a small Aseptic dual purpose suite for small-scale Fill & Finish into Vials and Pre-Filled Syringes (PFS). This suite was perfectly designed for early-phase sterile Drug Product manufacture and offered customers a full-service integrated supply by seamlessly combining Drug Substance (e.g. peptides & small molecules) with sterile Drug Product.
Due to the overwhelming success of the first aseptic production plant, combined with a growing unmet demand in the injectable market, plans were drawn up by early 2016 for a higher throughput suite designed to be suitable for late-phase and commercial manufacture of much larger batches. This new state-of-the-art, 2000 m2 aseptic commercial suite is divided into two separate parts: Area 1 for PFS & Cartridges and Area 2 for Vials. Both areas employ robotics for filling and online in-process weighing, adopting a ready-to-fill nest & tub material format with production capability of up to 10,000 units / hour with batch sizes from 10-200 L. Both areas additionally manage traditional compounding systems (such as stainless steel vessels), as well as “fully disposable systems.”
Area 1 was successfully inspected by the US FDA in July 2018, followed by an Italian Medicines Agency (AIFA) inspection in August 2018. Area 2 is expected to be fully approved and operational by Q1 of 2019.
Fabrizio Fiordigiglio commented, “The planning, execution, inspection and now inauguration of the new Aseptic Fill & Finish plant are testament to the team here at CordenPharma Caponago. We look forward to supporting our clients with this world-class facility, allowing us to now provide them with high quality sterile injectable Drug Products spanning early, late, and commercial phases.“
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