Idifarma expands its GMP manufacturing offering

Spanish contract development and manufacturing organisation (CDMO), Idifarma, has announced an expansion of its manufacturing site in Pamplona, Spain, with the installation of new automatic capsule filling capabilities.

The Bosch GKF-702 automatic capsule filling machine is already fully operational and will be used to support the manufacture of small-scale clinical and commercial batches. Additionally, the machine, capable of manufacturing 3,000 to 42,000 hard capsules per hour, will provide Idifarma with the ability to simulate industrial production environments during research and development (R&D).

“The latest addition to our facility in Pamploona is a fantastic development for Idifarma, helping us to bolster our manufacturing capabilities and reinforce our position as a specialist CDMO for small-scale niche products in solid oral forms,” explained Luis Oquiñena, general manager and co-founder of Idifarma. “The GKF-702’s modular design will help us to future proof our investment ensuring that we can add real value to our clients’ manufacturing and development projects over the coming years. It is important for us to remain versatile and flexible, however, we will continue to focus on specialized low-volume and high potent pharmaceutical products which is a key differentiator for us.”

Idifarma’s Pamplona site was successfully audited by the Spanish Medicines Agency in June and with this investment the company aims to strengthen its position as a CDMO for oral solid dosage forms. The investment includes a minibowl for small R&D batches, and the GKF-702 comes with an industrial PC that is 21 CFR part 11 compliant and benefits from a variety of interfaces, making batch documentation easy to access.

Furthermore, the company has invested in new analytical equipment at the same facility, including an Agilent gas chromatography system and dissolution apparatus and four Waters high-performance liquid chromatography systems.