Aenova Launches Program to Accelerate Pharmaceutical Development
Aenova announces the launch of its Aenovation program. This initiative aims to accelerate the early development of pharmaceutical formulations.
In particular, the critical challenges of the bioavailability of poorly soluble drug candidates and their rapid market launch are to be mastered. More than 80% of drug candidates fall into either BCS Class II (poor solubility, high permeability) or Class IV (poor solubility, low permeability) of the Biopharmaceutics Classification System (BCS). Many of these poorly soluble compounds address therapeutic areas with high unmet medical need and require accelerated development to make these important therapies available to patients more quickly. Consequently, time to market and resource efficiency are key competitive advantages.
Aenova's CDMO strategy to meet these market needs ranges from strengthening development services by implementing innovative technologies and platforms to improve bioavailability to the new Aenovation program to accelerate early-stage development, as the formulation process is a critical part of any drug development.
Key features of the Aenovation program
The Aenovation Program is designed to optimize pharmaceutical development through a science-based selection of formulations and technologies. The program comprises three steps for the development of pre-formulations and formulations: First, the API undergoes thorough evaluation and testing as part of API profiling and developability classification to determine solubility, permeability, solids properties and powder physical properties. This step ensures a sound developability classification that guides the formulation strategy. Secondly, the formulation and prototype selection phase involves a rapid and API-friendly screening program using solubility enhancement technologies. This phase includes process simulation, analytical characterization, accelerated stability assessment programs and the delivery of prototypes for preclinical studies. Finally, thirdly, the production of materials for the early clinical phase involves the seamless transfer to GMP-compliant laboratory and pilot areas. This phase includes the validation of analytical methods and the provision of materials for initial human clinical trials in record time.
The Aenovation program is scientifically sound and brings innovative substances quickly into early clinical phases (first-in-human). It is based on comprehensive, proven protocols that cover all relevant formulation options and technologies. With this structured approach, innovative pharmaceutical companies, including biotech start-ups, can achieve significant benefits: rapid development with right-first-time results and efficient processes. This makes the Aenovation program a catalyst for the preclinical and early clinical phases, but also a catalyst for accelerating biotech innovation.
Comprehensive development services and innovative technologies for improved bioavailability
Aenova's services cover the entire value chain from development to commercial manufacturing and cover all common product groups and dosage forms, including solid, semi-solid, sterile and non-sterile liquid forms. The extensive technology offering includes spray drying, melt extrusion, lipid-based systems, microdosing in capsules and targeted release formulations. More than 170 scientists and analysts in seven specialized development centers support early drug development for customers and ultimately patients worldwide. In addition, Aenova is continuously expanding its range of services by investing in new technologies and capacities.
With this broad range of services, many options are available to improve the bioavailability of new and difficult-to-handle drugs or new chemical entities (NCEs) from preclinical development to commercial production. With all steps from a single source, Aenova offers its customers seamless processes from the beginning to the end of a drug's life cycle.
"With our expanded range of development services, we can help pharmaceutical and biotech companies accelerate their programs and optimize their resources," said Florent Bordet, Chief Scientific Officer at Aenova. "Our Aenovation program reflects our commitment to innovation and excellence in pharmaceutical development."
