INDENA: always at the forefront of CDMO services

30-Nov-2021

In 2021, Indena proudly celebrated one hundred years of pharmaceutical excellence based on medicinal plants

Our scientific approach to dietary supplements and ongoing commitment to botanical quality are just a couple of milestones in a long history, which has enabled INDENA to become a leader in the field of botanical active ingredients. This leadership is deeply rooted in the pioneering spirit of its founders, from whom the company still derives its ability to make a difference in terms of innovation, quality, technology, manufacturing and sustainability.

Among INDENA’s many different business areas, our custom development and manufacturing serves rank as priority for strategic development. For years, and even more so today, by implementing the latest innovations, INDENA has remained a full-service provider and reliable partner in the field of cGMP contract development and production of active pharmaceutical ingredients (APIs) and highly potent active pharmaceutical ingredients (HPAPIs).

As such, the company effectively supports leading pharmaceutical and biotech companies to achieve product success and guarantee healthier lives for patients.

With the aim of providing customers with an increasing breadth of services, the company has invested in cutting-edge technologies, particularly regarding the expansion of our GMP pilot plant and by upgrading the spray drying technology that already existed within our facility.

INDENA’s CDMO services include a full range of manufacturing capabilities for pharmaceutical ingredients, including the extraction, isolation and purification of natural derivatives and the processing and manufacturing of synthetic molecules.

This combination of INDENA’s expertise with state-of-the-art facilities allows the company to deliver products and processes that range from small-scale orders for GMP batches for clinical use to large commercial manufacturing supplies. Moreover, with its highly specialised quality assurance (QA) system and regulatory expertise, INDENA is able to meet the strictest requirements of global agencies.

New kilo lab LK2 and pilot-scale hydrogenator

Wishing to increase and improve its services to customers, INDENA has decided to double the capacity of its kilo lab LK2 for OEB 5 products. As a matter of fact, the new kilo lab, which will be ready at the beginning of 2022, will be capable of running large-scale (60 L) reactions. This expansion completes INDENA's production capacity for HPAPIs, allowing the company to offer different capacities for products at the highest containment level (OEL 20 ng/m3 or OEB5).

Furthermore, to meet market requests in the most efficient and flexible way, INDENA will be installing a 250 L hydrogenator that will be ready at the end of 2022. Together with the existing 20 L hydrogenator, the new one will allow INDENA to satisfy a wider demand for this kind of service.

New production pilot plant for active pharmaceutical ingredients

To constantly meet and surpass its customers’ expectations, INDENA has been working on complementing its GMP pilot plant for active pharmaceutical ingredients with a second facility equipped with 10,000 L reactors. The plan is to upgrade the system and exploiting INDENA’s technologies at a larger scale by installing a state-of-the-art system that complies with the sector’s best practices: engineering, safety, quality and scale.

INDENA's goal is to offer customers the ability to run synthetic processes in a wide range of conditions for both natural molecules — that require semisynthetic steps — and synthetic ones.

Mid- and large-scale spray dryers for amorphous solid dispersion

Backed by more than 30 years of experience, INDENA has been expanding and upgrading its mid- and large-scale spray dryers — and ensuring that they’re compatible with organic solvents. The recent installation of a GEA PSD2 spray dryer, which allows intermediate production scale and guarantees good (OEB4-compatible) containment, has been joined by a revamped ATZ4 spray dryer, which has been in place for several years.

The ATZ4 has a production capacity that’s 3–4 times greater than then PSD2, thus allowing larger-scale services in this specific area and completing the INDENA CDMO offer.

Vaccine excipients

INDENA is currently finalising a suite to produce vaccine excipients on a larger scale. It is the expansion of a plant that’s already being utilised for the same purpose: the production of vaccine excipients using preparatory and freeze-drying HPLC in a GMP area.

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One hundred years of history is an important heritage; at the same time, it’s a vital link to the future. Whatever challenges lie ahead, INDENA is ready to face them — thanks to the company’s strong core, resilience and a vision that combines experience, tradition and a constant drive to innovate.

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