Inspiration, Creativity, and the Strength of Teamwork

Aenova, a leading Contract Development and Manufacturing Organisation (CDMO) in the healthcare industry, has successfully completed a complex project for a global pharmaceutical client. The project involved the technology transfer and scale-up of a fixed-dose combination, demonstrating Aenova's expertise, operational excellence, and commitment to quality, innovation, and customer-focused solutions in pharmaceutical manufacturing.

George Shlieout, the Head of Manufacturing Science & Technology at Aenova, led the project. Shlieout, a pharmacist with a PhD in Pharmaceutical Technology and Biopharmacy, brings over 20 years of experience in the pharmaceutical industry to the table.

The project presented several challenges, including process complexity, equipment & scale-up, regulatory compliance, timeline sensitivity, and ensuring consistent batch-to-batch quality. To overcome these challenges, Aenova employed advanced process analytical technology (PAT) for real-time monitoring of granulation and coating uniformity. Data-driven scale-up was achieved using quality by design (QbD) principles and design of experiments (DoE) to optimize process parameters.

Collaboration was fundamental to the project's success. A dedicated tech transfer task force worked closely with the client's team to ensure a seamless transition. External partnerships with CROs, active pharmaceutical ingredients manufacturers, and suppliers expanded capacity and capabilities while maintaining agility. Fostering collaboration with academia, pharmaceutical innovator firms, and technology providers accelerates innovation, secures technology transfer, and enhances production capabilities.

The project required a fast and risk-mitigated transfer from the client's in-house manufacturing facility to Aenova's commercial manufacturing site. 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.

The project led to convincing results, including first-time-right commercial batches, accelerated time-to-market, and a long-term partnership with the client. Aenova's work is driven by a strong sense of purpose to make a tangible impact on improving lives and bringing high-quality medicines to market.

Working for a medium-sized CDMO like Aenova differs significantly from working for Big Pharma, particularly in terms of flexibility, customer focus, and decision-making dynamics. 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. Diversity in all forms - ethnic, cultural, generational, educational, and experiential - has a strongly positive impact on a team's success.

In the pharmaceutical industry, several key challenges must be addressed to ensure medical care for a growing global population. These include rising drug development costs, complex regulatory hurdles, ensuring affordable access to medicines, supply chain vulnerabilities, pricing transparency and public perception, ethical and political pressures, and environmental sustainability. Aenova's approach underscores its commitment to addressing these challenges and contributing to a healthier world.

Current innovations accelerating drug development and production include continuous manufacturing quality assurance tools like Gericke’s precision sampling valve for oral solid dosage forms, advanced machine learning methods improving catalyst simulation accuracy for more efficient chemical processes, rapid and precise cleanroom construction enabled by modern simulation technologies, and the development of novel biochemical cofactors facilitating targeted therapies and clinical trial readiness. These innovations, coupled with integrated genomic data analysis platforms and collaborative radiopharmaceutical manufacturing, are enhancing the speed and reliability of pharmaceutical innovation.

Regulatory excellence was demonstrated through comprehensive CMC documentation and successful support for the client's regulatory submissions, leading to first-pass approvals across multiple agencies. Agile problem-solving was demonstrated during validation, where minor dissolution variability due to equipment differences was quickly addressed without compromising quality.

In conclusion, Aenova's successful completion of this complex project underscores its position as a reliable and innovative CDMO in the pharmaceutical industry. By leveraging a strategic combination of expertise, technology, and operational excellence, Aenova is well-positioned to address the challenges facing the pharmaceutical industry and contribute to a healthier world.