Workshop: From Large Molecules to Advanced Therapies

The evolution from small molecules to biologics and advanced therapies has transformed the pharmaceutical landscape but it has also introduced unprecedented analytical complexity.

Join us for a full‑day scientific workshop exploring the evolution from small molecules to biologics and advanced therapies — and the analytical challenges that have shaped each step of this transformation.

Through expert-led sessions and real-world case studies, you will gain a comprehensive understanding of how analytical science underpins product quality, regulatory compliance, and patient safety across modern therapeutic platforms.

During this workshop you will learn:

By attending you will gain a complete overview of how analytical science supports the evolution from small molecules to mAbs, viral vectors, and advanced therapies — covering release testing, critical quality attributes, raw material control, method lifecycle management, real case studies, and the future of analytical expectations.

9.00 am - 9.30 am | Welcome and introduction

• From the origins to today: The journey from small molecules to biologics and advanced therapies
• Analytics as an enabler:Why analytical science is the cornerstone of quality andcompliance
• Workshop objectives: Understanding analytical challenges throughout this evolution

9.30 am - 11.15 am | Session 1: Monoclonal Antibodies (mAbs)

• The era of mAbs: The first major leap from small molecules to biologics
• Analytical release panel for mAbs: Key tests and regulatory expectations
• Characterisation and stability challenges: Lessons learned over time
• Viral clearance: A critical step in mAbs manufacturing
• Case studies: Real-world examples of analytical hurdles and solutions

11.15 am - 11.30 am | Coffee Break

11.30 am - 13.00 pm | Session 2: Non-enveloped Viral Vectors

• From biologics to gene therapy: The evolution toward complex products
• Analytical release panel for AAV & AdV based products: Critical quality attributes
• Testing across complex matrices: New challenges compared to mAbs
• Viral clearance: The evolution of the concept, from traditional clearance in mAbs
• to innovative approaches in advanced therapies
• Case studies: Overcoming analytical complexity in advanced therapies

13.00 pm - 14.00 pm | Networking Lunch

14.00 pm - 15.00 pm | Session 3: Biological Raw Materials

• The role of raw materials over time: From secondary components to critical factors
• Analytical scrutiny: Why variability impacts product integrity
• Analytical strategies: Ensuring consistency and compliance

15.00 pm - 15.45 pm | Session 4: Managing Analytical Methods through Tech Transfers and Validation

• From pioneering phases to standardisation: How method transfer and validation evolved
• Best practices: Avoiding common pitfalls
• Validation pillars: Current requirements and future trends

15.45 pm - 16.15 pm | Wrap up and Q&A session

• Key takeaways: What we learned from the evolution of biologics
• Open discussion and next steps: Addressing future analytical challenges

Giulia Mancini
Giulia Mancini works as Cluster Manager for the Bioassay and Cell & Gene Therapy team in Biologics division, where she leads two cross-functional teams focused on the development and validation of advanced analytical platforms for biologics and ATMPs. With a PhD in Biochemical Sciences and an MBA from POLIMI Graduate School of Management, she blends deep scientific expertise with strategic leadership. Her role spans technical innovation, operational excellence, and business-driven decision-making, leading and developing high-performing teams, and ensuring efficient workflow and compliance with GMP standards, with a focus on collaboration and delivering quality bioassay solutions that support organisational goals and regulatory expectations.

Giuseppe Peddio
Giuseppe holds a Chemistry and Pharmaceutical Technology degree and a Ph.D in Neuroscience from the University of Cagliari. He has a vast experience as bioanalytical researcher through Chromatography method development and validation mainly related to pharmacokinetic studies by LC-MS and LC-MS/MS. In his previous experiences as GLP Laboratory Manager he has successfully managed different projects in a wide range of areas and he has been involved in Studies of Bioequivalence in collaboration with the National Research Council for drug product and impurities qualitative/quantitative characterisation. Since 2017 he has been working at Eurofins BioPharma Product Testing Italy at first as Project Leader of extractables & leachables studies and for the last seven years as Manager of a Chemical and Biochemical Laboratory working in GMP focusing on Biologics products characterisation and analysis.

Elena Morelli
Elena earned a Ph.D. in Molecular Medicine from the European School of Molecular Medicine (SEMM), IFOM (Milan). She subsequently participated in research projects as a postdoctoral researcher at IFOM and the University of Milan. In 2020, Elena joined Eurofins BioPharma Product Testing Italy as a GLP Study Director in the Virus Testing Unit Lab. She has been involved in viral disinfection efficacy tests and viral clearance validation studies on various test materials, developing solid expertise in viral inactivation. She is currently focusing on chromatography-based methodologies to ensure robust and reliable viral clearance validation studies within the Virus Testing Unit Laboratory.