Aenova launches bioavailability programme, AenovationTM

Published: 9-May-2025

The solution helps pharmaceutical developers to improve the bioavailability of their drug candidates, expediting the process to commercialisation

CDMO Aenova has launched AenovationTM, a pharmaceutical development tool designed to address challenges associated with poorly soluble drug candidates.

The programme is designed to fast-track early formulation development — specifically addressing bioavailability.

More than 80% of drug candidates fall into either the Biopharmaceutics Classification System (BCS) Class II (poor solubility, high permeability) or Class IV (poor solubility, low permeability).

Many of these poorly soluble compounds address areas of high unmet medical need, requiring an accelerated development to bring these critical therapies to patients more quickly. Consequently, time-to-market and resource-efficiency are key competitive advantages.

Aenova's CDMO strategy to meet these market demands ranges from strengthening its development services in general by implementing innovative technologies and platforms to improve bioavailability to the new AenovationTM programme to accelerate early-stage development, as the formulation process is a critical part of any drug development pipeline.

 

Key features

The AenovationTM programme is designed to streamline pharmaceutical development deploying a science-based rationale selection of formulation and technology.

The programme approaches pre-formulation and formulation development in three steps: First, API profiling and developability classification involves a thorough assessment and testing of the API to understand its solubility, permeability, solid-state properties and powder physical characterisation.

This step ensures a well-founded developability classification, which guides the formulation strategy.

Second, the formulation and prototype selection phase include a fast and API-sparing screening programme that utilises solubility enhancement technologies. This phase encompasses process simulation, analytical characterization, accelerated stability assessment programs, and the supply of prototypes for pre-clinical studies.

Finally, the early clinical phase material manufacturing includes seamless transfer to GMP lab- and pilot-scale environments. This phase involves validating analytical methods and supplying materials for first-in-human clinical trials in record time.

The AenovationTM program is science-based and provides a proven way to rapidly advance innovative substances into early clinical phases (first-in-human). It is designed around comprehensive, proven protocols that cover all relevant formulation options and technologies.

This structured approach enables pharma innovators, including biotech start-ups, to achieve significant benefits: rapid development, right-first-time results, and efficient processes. Thus, the AenovationTM program is a kick-start for preclinical and early clinical phases, but also a catalyst for accelerating biotech innovation.

“Aenova’s extended range of development services allows us to support pharmaceutical and biotech companies in accelerating their programs and optimizing their resources,” said Florent Bordet, Chief Scientific Officer at Aenova. “Our AenovationTM program is a reflection of our commitment to innovation and excellence in pharmaceutical development.”

By streamlining the development process, Aenova helps deliver critical therapies to patients faster and more reliably.
For more information, please visit Aenova’s website www.aenova-group.com

 

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