Aenova, a contract development and manufacturing organisation (CDMO) in the global pharmaceutical supply chain, announces the launch of its Aenovation program.
Aenova
This new initiative is designed to fast-track early development of pharmaceutical formulations, specifically addressing the critical challenges of bioavailability and time-to-market for poorly soluble drug candidates.
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 Aenovation program to accelerate early-stage development, as the formulation process is a critical part of any drug development pipeline.
Key features of the Aenovation program
The Aenovation program is designed to streamline pharmaceutical development deploying a science-based rationale selection of formulation and technology. The program 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 program that utilises solubility enhancement technologies. This phase encompasses process simulation, analytical characterisation, 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 Aenovation 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 startups to achieve significant benefits: rapid development, right-first-time results and efficient processes. Thus, the Aenovation program is a kick-start for preclinical and early clinical phases, but also a catalyst for accelerating biotech innovation.
Comprehensive development services and innovative technologies for enhanced bioavailability
Aenova’s services span the entire value chain from development to commercialisation, covering all common product groups and dosage forms, including solid, semisolid, sterile, and non-sterile liquid forms. The company’s extensive technology offering includes spray drying, hot-melt extrusion, lipid-based systems, capsule micro-dosing, and designed release formulations. More than 170 scientists and analysts in seven specialised development centers support early drug development for the 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 for improving the bioavailability of new and difficult-to-handle APIs or new chemical entities (NCEs) from preclinical development to the commercial production. With all steps from a single source, Aenova offers its customers seamless processes from the beginning to the end of the drug product life cycle.
“Aenova’s extended range of development services allows us to support pharmaceutical and biotech companies in accelerating their programs and optimising their resources,” said Florent Bordet, chief scientific officer at Aenova. “Our Aenovation 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.