The central role of contract manufacturers in pharmaceutical supply

Starnberg, 31/10/2023

How CDMOs help ensure the supply of medicines

Contract manufacturers have a pivotal role in drug supply worldwide, and the trend toward outsourcing continues unabated. Reasons for this include expiring patents on small molecule drugs, the increasing number of small molecules in clinical trials, the rise in chronic and age-related diseases, and the rapidly growing oncology market. At Aenova Group, one of the world's leading CDMOs (Contract Development and Manufacturing Organization) with around 4,000 employees worldwide, there is a significant increase in demand across all dosage forms and therapeutic areas, partly due to post-corona conditions. In this context, it is challenging to install all the necessary capacities, machines and staff, in a timely manner, as equipment manufacturers have long lead times and additional staff often have to be found.

Aenova is driving a growth strategy with massive investments for each site, either to expand existing capacity or to expand the range of innovative technologies. In total, there are 14 new growth platforms at Aenova, eight of which are already commercially active.

Capacity expansions to meet increased demand

A few examples illustrate this strategy: the Aenova high-volume site in Tittmoning, Germany, has been expanded to a production capacity of ten billion tablets per year, and four new blister lines with significantly increased capacity will start there by the end of 2025. At the Latina site in Italy, a brand new sterile filling and finishing area (incl. biologics) for prefilled syringes and RTU vials was created. Follow-up investments of around EUR 15 million are currently underway there to increase capacity for prefilled syringes (PFS). In Carugate, Italy, production capacities for the manufacture of semisolids and non-sterile liquids have been expanded with an investment of around EUR 10 million. At the Regensburg site, the new building for the development and production of highly active pharmaceutical ingredients (up to OEB 5) was opened in June 2023, a total investment of around EUR 25 million. Capacities for effervescent products will be almost doubled at the Bad Aibling site by 2025. Aenova is investing significantly in expanding production in the area of all common dosage forms.

Innovative technologies for novel therapies

The development of new drugs for a wide range of therapeutic areas is a steadily growing market and is progressing rapidly. Therefore, a smart innovation strategy is essential for contract developers and manufacturers.A CDMO should actively support customers with innovative approaches already during development services. At Aenova, there are currently various initiatives for differentiated technologies, which are primarily aimed at patient-friendly forms of therapy based on complex therapeutic systems and improved bioavailability of active ingredients.

Read more in the current issue of CHEManager 10/2023 (in German).