Session XV of the 64th AFI Symposium will be entirely dedicated to pharmaceutical production and promises to be an unmissable opportunity to delve into the challenges and future prospects of the production sector.
An overview of production challenges
Session XV will be divided into two distinct parts, offering a comprehensive overview of both production issues and investigational medicinal products. The aim is to provide a complete picture that combines the concreteness of industrial needs with the drive for innovation that has always characterized the pharmaceutical world.
The first part will focus on operational issues related to production, starting with the analysis of IT support for production activities. Indeed, digitalization and automation have become indispensable tools today to ensure the quality, traceability, and efficiency of processes. Emilia Imbriani and Rita Zacchilli of Angelini Pharma will offer a reflection on how the integration of IT systems can optimize operations, reduce the risk of human error, and improve overall company performance.
Focus on cross-contamination in non-sterile sites
Another central theme of the session will be the management of cross-contamination in non-sterile facilities. Traditionally associated with the production of sterile drugs, this issue is now the subject of a broader debate that also involves non-sterile products. Alessandro Zenoni of IBSA will delve into the strategy and criteria for extending the guidelines contained in the new Annex I of the GMP, which provide for the application of stricter containment measures. This represents both a cultural and technical shift that requires a review of procedures and production structures to ensure drug safety and quality.
The challenge of serialization
Serialization, another key theme of Session XV, represents a fundamental piece in the fight against counterfeiting and the protection of public health. In Italy, its implementation presents some peculiarities compared to the European context. Luca Perani and Adriano Pietrosanto will illustrate the main differences and the critical issues that companies must face to comply with both national and European regulations. Serialization is not merely a technical measure; it is a real paradigm shift in the management of the pharmaceutical supply chain.
Investigational medicinal products: rigor and innovation
The second part of Session XV will be dedicated to investigational medicinal products, with three presentations offering valuable insights to address the complexities associated with these experimental drugs. Sebastiano Carangelo and Claudio Pagani will open the discussion with a presentation focused on the importance of risk analysis in the production of these drugs in traditional plants. Compliance with good manufacturing practices (GMP) and ensuring cleanliness and process quality are essential aspects for patient safety and regulatory compliance.
Design quality in the development of new products
Marinella Capuzzi and Silvia Piersanti will shift the attention to the initial design phase of non-traditional products. Often underestimated, this phase proves crucial in ensuring a robust and efficient production process. The two speakers will explore the most effective methodologies and strategies for structuring design quality from the early stages, integrating the latest technologies and tackling the challenges of an ever-evolving market.
New frontiers: injectables and nanoparticles
Concluding Session XV will be the presentation by Umberto Romeo and Giovanni Gezzi, dedicated to the production of experimental injectable products based on nanoparticles and lipid nanoparticles. These pharmaceutical forms represent the most advanced frontier of research and offer promising therapeutic opportunities. However, their production requires a rigorous, multidisciplinary, and highly innovative approach to ensure the safety and effectiveness of treatments.
An opportunity to engage and look to the future
While awaiting the start of Session XV, it is clear that the topics on the agenda offer a snapshot of the main challenges and opportunities facing the sector. Pharmaceutical production today is a laboratory of innovation, where digitalization, quality, safety, and sustainability intersect to build the future of the industry and public health.
The 64th AFI Symposium, a long-standing crossroads of expertise and ideas, once again confirms itself as a privileged moment to stimulate the cultural and technical growth of the sector.
