CPHI Americas 2025: Working End-to-End
The Pharma Navigator sits down with Mara Candido from Aenova to learn more about the one-stop-shop experience, benefits of working with an end-to-end service provider, how advanced formulation strategies can aid with bioavailability/solubility issues, and the company’s focus for this year’s CPHI Americas event.
The dynamics of the pharmaceutical industry have shifted over the years, with companies being required to adapt to changing market conditions, new socio-economic landscapes, and novel therapeutic targets of interest (1). To be able to manage these changes effectively, pharma companies are leaning more heavily on the expertise and capabilities provided by CDMOs, who in turn are needing to provide more comprehensive services and one-stop-shop style offerings to meet demand (2).
To discuss these shifts in more detail, including what is meant by one-stop-shop services, why end-to-end offerings are beneficial for innovators, and how advanced formulation strategies can aid in overcoming bioavailability and solubility issues, The Pharma Navigator sat down with Mara Candido, VP Global Business Development at Aenova.
A One-Stop-Shop Experience
TPN: Can you explain what is meant by ‘one-stop-shop’ in terms of partner services?
Candido: The one-stop-shop experience should stretch from early-phase formulation and product development to raw material sourcing, analytics, clinical trial supply management, regulatory support, small and commercial scale production through to packaging and logistics. Aenova, as one of the leading CDMOs in the global pharmaceutical supply chain, provides services for all common pharmaceutical and nutraceutical product groups and dosage forms — solids, semi-solids, sterile, and non-sterile liquids – for both human and veterinary use. Additionally, Aenova develops, produces, and packages across a network of 14 sites in the U.S. and Europe. The manufacturing sites are complemented by seven Development Centers of Excellence dedicated to specific technology and dosage form expertise. Furthermore, we have capabilities for specialty technologies such as highly potent API (HPAPI) containment (handling of APIs up to OEB 5), low-dose capsule filling, modified release formulations, organic granulation, particulate systems, lipid-based formulas, hot melt extrusion or spray drying for poorly soluble compounds.
Benefits of End-to-End Services
TPN: Are there any specific ‘pain points’ where providing such integrated and/or end-to-end services is particularly beneficial?
Candido: A major consideration for sponsor companies is reducing the time it takes to get a drug to clinic and to market. Working with the same partner across different products or phases enables faster progress and decision-making, as processes, data formats and systems are well-known and optimized. The ability to scale across clinical phases and into commercial supply on same-type equipment provides high consistency and speeds up time to clinic, market, and patients.
Additionally, working with a single partner who can provide end-to-end services helps to minimize risk and cost. Switching or adding new partners, whether during development or for commercialization, often involves transfer risks such as knowledge loss, delays, and increased costs. Collaborating with an experienced CDMO across multiple development phases or product lines helps minimize these risks, reduce partner management complexity, and control costs.
Furthermore, ensuring there is trust and reliability in the partnership is key. We understand that trusting an external partner with your business and sharing valuable knowledge with them is not always an easy decision. Trust is built over time and having a partner who demonstrates expertise and reliability across the value chain, shares your passion, and with whom you can develop a common language and knowledge base, makes doing business significantly easier.
Identifying the Optimal Formulation
TPN: Could you discuss ‘advanced formulation strategies’ to address bioavailability and solubility issues in more detail please?
Candido: There are a variety of technologies and approaches that can be employed to address bioavailability and solubility challenges in oral solid dosage formulations, including spray drying, hot-melt extrusion, and lipid-based systems. For early-stage development programs, Aenova’s new Aenovation program has been specifically designed to accelerate the selection of the most appropriate technology, using science-based rationale to identify the optimal formulation and processing route. Low-dose capsule filling further supports a fast-to-clinic strategy.
Finding Solutions for Hard-to-Place Formulas
TPN: What is Aenova most looking forward to at CPHI Americas this year?
Candido: We are looking forward to meeting organizations that need specialized and focused contract services. Aenova thrives on uncovering optimization potential and finding solutions for those hard-to-place formulas. We welcome the opportunity to impress with our technical expertise and our willingness to take on challenging projects.
TPN: Can you highlight any specific innovations that Aenova will be presenting at the show?
Candido: Aenovation, Aenova’s early-stage development program designed to facilitate rapid first-in-human studies with a focus on poorly soluble APIs and capsule micro-dosing, a technology that allows to shortcut pharmaceutical development timelines.
TPN: Where can visitors find Aenova at CPHI Americas? What is the booth number etc.?
Candido: Aenova will be located on Booth #812 at CPHI Americas. For project enquiries or further information, you can also contact us at contact-sales@aenova-group.com or +1-336-665-1300.
References
PwC. Next in Pharma 2025: The Future is Now. Report, January 2025.
Hayek, M.; Schroeter, I.; Mathew, S.; et al. Navigating Toward New Horizons in Pharma Operations: The End-to-End Transformation Imperative. Kearney.com, Article, June 11, 2024.
Photo by Mohamed Marey on Unsplash