Recent innovations in production of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) have improved development standards and progress for important treatments in the area of oncology.
While manufacturing challenges still exist, these molecules have improved industry standards due to their effectiveness at much smaller doses than traditional APIs and have received strong interest in the industry over recent years.
Lonza offers trusted products for companies developing and manufacturing HPAPIs for use in various areas of medicine while maintaining high standards for manufacturing quality and performance, and over 15 years of experience in HPAPI manufacturing and development.
Cost Reduction: A wide range of production scales, from lab scale to 10m3, means we can take your product from early development to launch and in-market supply without additional technology transfer costs.
Time Savings: A valuable track record of over 10 products scaled up, experience with a wide variety of highly potent compounds, and the right process, plants and highly trained people can minimize errors, reduce rework and improve time to market.
Peace of Mind: Our cutting-edge facilities, extensive product experience, and expert evaluation procedures help you rest assured that your highly potent API is in safe hands.
Proven Track Record
Lonza boasts 15 years of historical expertise in handling hazardous compounds, working with HPAPI manufacturing at various production scales from small scale to 10m3 capacities. We currently have active projects for the areas of oncology, immune-suppression and veterinary medicine. With Lonza you gain Swiss quality and standards in every part of your product life cycle.
The Experience and Trust You Deserve
- Over 110 years of chemistry know-how and a 15 year, multi-product history
- Antibody drug conjugates unit with lab to plant scale experience since 2008 (OEL down to 40ng/m3 of air)
- Appropriate containment and product segregation\
- Training and development expertise specifically designed for handling HPAPIs
- Active projects with OEL ranging from 5 to 0.04 mg/m3