4th Annual Highly Potent APIs Virtual Summit 2024

Conference Overview

The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges. Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies.

The featured talks on:

• HPAPI Process Design and Project Implementation
• Manufacturing of Oncological Products by a CDMO
• Garment selection criteria for the safe handling of HPAPI
• HPAPI manufacturing in early Chemical Development
• How to handle HPAPIs within Chemical Development
• What are some hidden risks associated with isolators?
• Case Study: How to develop a high potent Antibody Drug Conjugate ADC production suite
• A Systematic Approach to the Safe Handling of Potent Active Pharmaceutical Ingredients
• Looking Beyond Pharma 4.0: Future Initiatives and Advanced Manufacturing Approaches
• Sources of cross-contamination risk in solid dosage form manufacturing
• Cleaning validation – Enhanced approach required for Highly Potent APIs?
• EHS Integration in Capital Projects and Tech Transfer
• Integrating EHS into the RFP Process for HPAPIs
• Quantitative Measurement of Risk in Cleaning using ASTM Standards
• Occupational Hygiene Programs and Practice Standards of Care
• The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs)
• Exposure Assessment Challenges for New Modality Potent Compounds in R&D
• Flexible Isolator- Occupational Hygiene Experience
• Occupational Exposure Bands (OEBs)
• Health-based exposure limits (HBELs) for biotechnological products
• How to derive health-based exposure limits (HBEL) for ADCs
• HBEL - containment and occupational hygiene monitoring
• Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient biopharmaceutical drugs.
• Ensuring product & worker safety in multi-product GMP facilities.
• Continuous Processing as a Tool for HPAPI Development and Manufacturing
• Design Considerations for the Buildout of a New Small Molecule HPAPI R&D Laboratory