Motivation, Innovation, and the Power of Collaboration

George Shlieout, Head of Manufacturing Science & Technology, Aenova

© Aenova

CHEManager: What are the biggest challenges the pharmaceutical industry is facing today in order to secure medical care for the growing world population in the future?

George Shlieout: The pharmaceutical industry faces several key challenges in ensuring medical care for a growing global population. Rising drug development costs and complex regulatory hurdles contribute to long timelines and high expenses. Ensuring affordable access to medicines, especially in low-income regions, remains a critical issue, further strained by an aging population’s increasing demand for chronic disease treatments. Supply chain vulnerabilities pose risks to drug availability, while pricing transparency and public perception fuel ongoing debates. Additionally, ethical and political pressures influence regulatory decisions, and environmental sustainability is becoming a growing priority for greener manufacturing and waste management.

How can these challenges be addressed?

G. Shlieout: Addressing these challenges require innovation, cooperation, and strategic approaches to ensure future healthcare access. Contract Development and Manufacturing Organizations (CDMOs) like Aenova play a crucial role by providing time efficient, cost-effective and flexible solutions for drug development and manufacturing. They help pharmaceutical companies scale up production, reduce time to market and therefore costs, and manage complex manufacturing challenges, enabling faster access to medicines and supporting innovation, particularly for small and mid-sized drug developers. Aenova also supports the global supply chain by ensuring high-quality, efficient production to meet the growing demand for medicines.

The development of new drugs is time-consuming, cost-intensive and highly regulated. How does Aenova support the development process of new drugs from drug discovery to approval?

G. Shlieout: Aenova plays a vital role in supporting the development process of new drugs, from early development during candidate selection, to approval, by offering specialized expertise, resources, and infrastructure. Aenova is capable to provide End-to-End Services. Here's how we contribute at each stage:

Early development: 

Aenova launched an Aenovation program to support pharmaceutical companies during the early stage of product development by providing a pre-formulation lab to characterize the active substance and select one or two formulation candidates. With innovative technology platforms such as capsule micro-dosing, lipid-based formulations, hot melt extrusion and spray drying, Aenova provides key technologies that can be used to improve the active substance solubility and increase the bioavailability. 

Clinical development (Phase I-III): 

- Clinical trial manufacturing: Aenova is able to manage the production of clinical trial materials at small and large scale, packaging, labeling and distribution. By optimizing and scaling up the manufacturing process from bench scale production to pilot scale production, it is ensured that the process is reproducible and scalable for commercial production. 

- Commercial manufacturing: Once the product is approved, Aenova provides the infrastructure to scale up manufacturing, ensuring efficiency and consistency in production while adhering to Good Manufacturing Practices (GMP). The functions required to manage global supply chains and ensure the timely delivery of finished products support the reliable supply of customers and ultimately patients worldwide.

- Regulatory compliance and quality assurance: At each stage of development, documentation is provided in accordance with regulatory standards, which is essential for regulatory approval. Additionally, Aenova has rigorous quality control systems and testing implemented throughout the process to ensure the drug’s safety, efficacy, and stability. 

Aenova’s services cover the entire value chain for the development and production of all main dosage forms and product groups in the field of medicines. How does Aenova manage the complexity of being an end-to-end CDMO?

G. Shlieout: Aenova manages the complexity of being an end-to-end CDMO by leveraging a strategic combination of expertise, technology, and operational excellence across the entire pharmaceutical value chain.

Key strategies for dealing with complexity are:

1. Integrated service offering: Aenova provides a seamless transition from development to commercial manufacturing, covering formulation development, analytical services, regulatory support, and large-scale production.

This one-stop-shop approach minimizes handovers, reducing time-to-market and ensuring consistency in quality.

1. Cross-functional expertise: A dedicated cross-functional team consisting of R&D, MS&T, QA, regulatory, and supply chain collaborates closely to streamline technical transfers, scale-up processes, and regulatory approvals. In addition, Aenova's scientists have expertise across all major dosage forms including oral solids, semi-solids, liquids, soft gels, sterile injectables, etc., which allows Aenova to meet diverse customer needs.
2. Digitalization & data-driven decision-making: Advanced process analytical technology (PAT) and quality by design (QbD) principles are integrated to optimize formulations and manufacturing. Real-time data monitoring ensures process efficiency and proactive issue resolution.
3. Global network & agile supply chain: Aenova operates multiple manufacturing sites across Europe and beyond, offering flexibility and redundancy to mitigate supply chain risks. Robust procurement strategies ensure a stable supply of raw materials, reducing vulnerability to disruptions.
4. Regulatory & quality excellence: Strong regulatory expertise ensures global compliance (FDA, EMA, PMDA, etc.), facilitating approvals across different markets.
5. Customer-centric approach & tailored solutions: Aenova offers customized solutions based on client needs, whether for innovative molecules, generics, or high-potency drugs.

By combining scientific expertise, operational agility, and regulatory strength, Aenova successfully manages the complexity of being a true end-to-end CDMO, delivering high-quality pharmaceutical solutions efficiently and reliably.

What are recent innovations in manufacturing science and technology that have the potential to speed up the drug development and production process?

G. Shlieout: We have made significant strides in improving cancer treatment through innovative scale-up approaches and well-designed manufacturing processes. These innovations aim to enhance the efficiency, quality, and speed of producing cancer therapies, ultimately improving patient outcomes. Some key approaches include the implementation of streamlined manufacturing process and quality by design (QbD) strategy during technical transfer leading to increased efficiency by reducing production time and cost, enhancing product consistency and quality by eliminating batch-to-batch variability, and enabling faster scalability in response to demand, which is particularly important for high-demand cancer drugs or personalized treatments. I would also mention the implementation of advanced technology platforms, for example, hot melt extrusion, spray drying and lipid-based formulations, enabling an improvement of bioavailability of poorly soluble drugs or active pharmaceutical ingredients — APIs. This is not new to humanity, but it reflects very well the market-oriented, value-oriented and holistic approach of Aenova.

Can you share a significant project that exemplifies your team's commitment to innovation and quality in manufacturing?

G. Shlieout: One significant project was the technology transfer and scale-up of a complex fixed-dose combination for a global pharmaceutical client. The client approached us with a highly sophisticated fixed-dose combination oral dosage form that required a precise drug release profile, low-dose for one of the active compounds, and strict bioequivalence criteria. They needed a fast and risk-mitigated transfer from their in-house manufacturing facility to our commercial manufacturing site. Key challenges were:

• Process complexity: The formulation involved multiple granulation and coating steps, requiring tight process control.
• Equipment & scale-up: The client’s manufacturing process needed adaptation to our commercial-scale equipment while maintaining critical quality attributes (CQAs).
• Regulatory compliance: The product was intended for multiple global markets, requiring alignment with FDA, EMA, and emerging market regulations.
• Timeline sensitivity: The client had a strict commercial launch timeline due to patent expiry and market competition.

In terms of innovative solutions and execution, the following elements were involved:

• Advanced process analytical technology (PAT): In cooperation with our customer we implemented real-time monitoring for granulation and coating uniformity, ensuring consistent batch-to-batch quality.
• Data-driven scale-up: Using quality by design (QbD) principles, our team performed design of experiments (DoE) to optimize process parameters, minimizing variability.
• Cross-functional expertise: A dedicated tech transfer task force (global and local MS&T, QA, regulatory, and engineering) worked closely with the client’s team to ensure a seamless transition.
• Agile problem-solving: During validation, we detected minor dissolution variability due to equipment differences. Our team rapidly adapted process parameters to match the original drug release profile without compromising quality.
• Regulatory excellence: We provided comprehensive chemistry, manufacturing, and controls (CMC) documentation and successfully supported the client’s regulatory submissions, leading to first-pass approvals across multiple agencies.

Our approach led to convincing results and made significant impact:

• First-time-right commercial batches: The product met all quality and regulatory requirements in the first validation attempt.
• Accelerated time-to-market: We completed the transfer, validation, and submission ahead of schedule, helping the client gain a competitive edge.
• Long-term partnership: Due to the project’s success, the client entrusted Aenova with additional high-value formulations.

This project underscores our commitment to quality, innovation and customer-focused solutions in pharmaceutical manufacturing, in addition to demonstrating our expertise in complex formulations.

What role does internal and external collaboration play in your approach to managing Aenova’s global manufacturing network?

G. Shlieout: Collaboration is fundamental to effectively managing our global manufacturing network, ensuring operational efficiency, regulatory compliance, and customer satisfaction.
Internal collaboration is crucial for securing cross-functional integration of teams from R&D, quality assurance, regulatory affairs, and supply chain, that must collaborate to ensure seamless product development and production. Additionally, internal collaboration helps maintain global manufacturing standards — for example, GMP compliance — across multiple sites. Internal collaboration also secures operational efficiency via sharing best practices and continuous improvement initiatives across manufacturing plants to enhance efficiency and reduce costs. Furthermore, integrating digital platforms enable real-time monitoring, predictive analytics, and quick decision-making. Last but not least implementation of risk management and ensuring close coordination between sites helps identify potential disruptions and implement mitigation strategies quickly.
External partnerships with CROs, active pharmaceutical ingredients manufacturers, and suppliers expands capacity and capabilities while maintaining our agility. Fostering collaboration with equipment and raw material suppliers, packaging material and logistics partners ensures supply chain resilience, steady supply and distribution efficiency. Partnering with academia, pharmaceutical innovator firms, and technology providers accelerates innovation, secures technology transfer, and enhances production capabilities.
Last but not least, external collaboration with sustainability organizations helps in reducing the environmental impact of manufacturing processes. Aenova is making considerable investment in state-of-the-art cogeneration plants and photovoltaic systems and additionally, set periodic site energy audits for optimization.

Previous to Aenova you worked for almost 20 years in pharmaceutical development functions at Solvay and Abbott, respectively. How does working for a medium-sized CDMO in your current role differ from working for Big Pharma?

G. Shlieout: I joined Solvay Pharmaceuticals in 2002, and shortly after Solvay was acquired by Abbott Laboratories. My journey in Big Pharma shaped my knowledge, expertise and my leadership style. I worked in R&D and in Operations (MS&T) and contributed to the development and commercialization of many products in the global market. Additionally, I had the opportunity to be part of several scientific advice meetings with many regulatory agencies like US-FDA, Japan FDA, and many European and emerging market countries. Furthermore, I was leading global teams in different locations in Europe, India, Singapore, Brazil and other Latin American countries.
Working for a medium-sized CDMO differs significantly from my time in Big Pharma at Solvay and Abbott, particularly in terms of flexibility, customer focus, and decision-making dynamics.
In a CDMO, the focus is on serving multiple clients with diverse needs, whereas in Big Pharma, R&D and manufacturing are more internally driven. At Aenova, we must be highly adaptable to different customer requirements, regulatory expectations, and project timelines. Additionally, medium-sized CDMOs tend to be more agile in decision-making. Unlike large pharmaceutical corporations, where processes can be more complex and hierarchical, a CDMO can often implement changes and innovations more quickly, responding dynamically to market and customer demands.
At Aenova, innovation is driven by close collaboration with clients. Unlike in “Big Pharma”, where proprietary R&D pipelines dominate, we work across a broad range of products, technologies, and formulations, offering tailored solutions while leveraging our technical expertise. Overall, while Big Pharma offers stability and large-scale operations, working in a CDMO is more dynamic, customer-oriented, and fast-paced, requiring a strong ability to adapt, innovate, and collaborate across multiple projects and partners.

What motivates you about your job at Aenova? Do you see your work more as a profession or a vocation?

G. Shlieout: What motivates me most about my job is the ability to make a tangible impact — both for our customers and ultimately for patients. Working in a CDMO environment means we play a crucial role in bringing a wide variety of pharmaceutical products to market, often acting as the bridge between innovation and large-scale production. The diversity of projects, the challenges of problem-solving, and the need to stay at the cutting edge of technology and regulatory requirements make every day exciting.
I see my work more as a vocation than just a profession. The pharmaceutical industry is not just about business — it’s about improving lives. The ability to contribute to the development and production of high-quality medicines that help people worldwide gives my work a deeper sense of purpose. It’s also incredibly motivating to collaborate with talented teams, drive innovation, and find solutions that meet both customer and patient needs. At Aenova, the fast-paced, customer-focused nature of our work keeps me engaged, and the impact we make drives my passion for what we do.

Is there a particular incident or success story from your professional life that has confirmed this and even strengthened your dedication?

G. Shlieout: In 2009, I was working for a global company where we developed and launched a product tailored to the needs of Cystic Fibrosis — CF — patients. A year later, I attended the CF Foundation Conference, where I presented a poster, and our company had a booth. One CF patient approached the booth with questions about the medication’s use of this product with and without food, and whether this would affect its efficacy. I had just arrived at the booth when a marketing colleague told the patient, “You’re in luck; here’s the main inventor of the product, and you can ask him directly.” The patient turned to me and said, “First of all, I want to thank you for all your work on this successful product. You’ve improved the quality of my life.”
It took me a moment to fully absorb what he said, and I was both surprised and deeply moved. The feeling of pride, joy, and even goosebumps was overwhelming. Receiving such feedback directly from a patient using the product I had helped develop was incredibly impactful. This experience profoundly shaped my professional purpose: “Accelerated building a healthier world.”
At Aenova, while we may not be the original innovators of medication, we have a significant impact on medication development, availability and affordability — goals that align closely with my professional purpose. I am truly grateful to be a part of Aenova.

As an expert in leading global and multinational teams, does diversity of ethnicities, cultures, age groups, qualifications, and experiences have a positive impact on success? What is your recipe to turn a diverse team into a successful entity?

G. Shlieout: Yes, diversity in all its forms — ethnic, cultural, generational, educational, and experiential — has a strongly positive impact on a team’s success. A diverse team brings a broader range of perspectives, problem-solving approaches, and innovative ideas, which is crucial in an industry as dynamic as pharmaceuticals. It fosters creativity, enhances adaptability, and enables better decision-making by challenging conventional thinking.
However, and based on my experience in multinational big pharma companies, diversity alone is not enough —it needs to be effectively managed to become a true asset. My recipe for turning a diverse team into a successful entity includes having a clear vision, common goals and leveraging strengths and complementary skills, empowering team members to take ownership of their tasks and decisions, building trust by being fair, consistent, and supportive, and fostering an agile mindset that embraces change as an opportunity. Also, it is important to create an inclusive culture by fostering an environment where everyone feels valued and heard. This is reflected in one of Aenova’s core values “Everyone matters”. I encourage open communication and respect for different viewpoints, and I lead by example and show appreciation for different cultural and professional backgrounds.
A well-managed diverse team is not just more innovative and productive but also more resilient, capable of navigating global markets, and better equipped to solve complex challenges. The key is to turn differences into strengths and create a team that thrives on collaboration and mutual respect.