Panel – Enhancing Efficiency: Strategies for Building a Cost-Effective Manufacturing Framework

Exploring the growing role of 3D printing in pharmaceutical manufacturing, including personalized medication and dosage forms - Pharmaceutical 3D printing is a rapidly growing field, with more and more research groups in academia and industry investing time and resources to investigate its use to personalize medicine. 3D printing provides the ability to fabricate small batches of precise structures rapidly, allowing for the personalization of medication with varying dosage, color, flavor, shape, and drug combinations (polypills). This presentation will introduce the most promising 3D printing technologies in the pharmaceutical field and explore their potential to revolutionize pharmaceutical manufacturing in the future.

The successful execution of technical transfer and PPQ at CDMOs is fundamental to ensuring the quality, robustness, and consistency of pharmaceutical products. By adhering to rigorous protocols, CDMOs can effectively transfer manufacturing processes and establish reliable, robust processes, ultimately contributing to the success of drug development and patient safety. In this presentation the methods involved in the technical transfer process for intermediates and APIs from the parent company to the CDMO are discussed. This includes comprehensive information on the manufacturing process, equipment, analytical methods, and quality control procedures. Effective technical transfer ensures a smooth transition and minimizes any potential risks or deviations during the manufacturing process. Process characterization studies that are employed to evaluate process performance and capability are also discussed. It encompasses the identification, verification, and validation of critical process parameters and establishes their acceptable ranges to ensure consistent product quality. It is essential to meticulously evaluate and optimize these parameters to establish reliable manufacturing processes. Finally, the presentation includes case studies to illustrate these strategies and the successful execution of PPQ batches at the CDMOs, highlighting real-world examples of the benefits derived from effective technical transfer and PPQ processes. Through efficient knowledge transfer, meticulous parameter qualification, and rigorous batch analysis, CDMOs can establish reliable manufacturing processes that ensure the quality, robustness, and consistency of intermediates and APIs.

Join us for a series of rapid-fire talks on disruptive manufacturing technologies. AI - Unleashing the potential of AI in pharmaceutical manufacturing to streamline processes, enhance efficiency, and ensure product quality Advanced Manufacturing - Delving into the latest advanced manufacturing techniques that are revolutionizing the industry 3D Printing - Exploring the growing role of 3D printing in pharmaceutical manufacturing, including personalized medication and dosage forms

Ingenza is changing the game in drug substance production by embracing the concept of employing the best of what both chemistry and biology have to offer. We integrate fermentative, biocatalytic and chemical synthetic transformations at any stage in the manufacturing process. We are versatile and adaptable to meet the ever-increasing complexity of drug modalities within biological, synthetic and semi-semisynthetic targets. Our expertise can further define and highlight new opportunities to improve chemo- and bio-conversions, protein synthesis and analysis through smart manufacturing route design. Examples will include: an optimised protein production platform (codABLE®), biocatalytic conversions and state-of-the-art protein characterization.

With the cost of drug development rising and current processes slow and expensive, there is a growing need for new ways to make drugs. Join this session to learn how to disrupt the current model for more efficient production, and speed to market.