Pharmaceutical companies need consistent and reliable API quality without unexpected problems during the manufacturing of the drug product. Sometimes drug product failures are caused by unintentional changes of the physical parameters of active pharmaceutical ingredient. These failures are possible to avoid utilizing carefully optimized crystallization processes with highly automated manufacturing equipment.
This presentation will cover: Development and optimization (DoE) of a robust, and cost effective manufacturing processes, highly automated crystallization process, cost reduction by continuous improvement through API life cycle, controlling of the critical process parameters and – steps, manufacturing of highly potent API, planning of production waste during the development phase including cost efficient waste treatment in production, sustainability, cost reduction case study.
Find out more how costs and quality risks of your API can be minimized using robust processes. Learn how Fermion designs, optimizes and scales-up manufacturing process from laboratory scale to commercial production with full regulatory support of your API. There will also be a live Q&A at the conclusion of the presentation.
Grels Ingberg,
Senior QA Manager
Grels has almost 30 years' experience at Fermion focusing on API cGMP compliance. Previously he spent 7 years at Oy Medica Ab. Grels gained his Masters in Chemical Engineering from Abo Akademi University in 1978.
Arne Grumann,
Vice President, R&D
Arne has 14 years’ experience at Fermion developing various chemical processes for API production. Previously, he spent 2 years at AstraZeneca and 3 years at Oxford Asymmetry with experience in various areas in Organic Process Research and Discovery. Arne gained a PhD From York University in 1995.
- Learn how to consistently control API´s chemical and physical quality attributes using automated and optimized manufacturing parameters.
- How to ensure robust API crystallization by automated and controlled manufacturing processes
- Understanding importance of defining critical process parameters of API in process design
- Cost reduction by continuous improvement with full regulatory compliance
- Sourcing Manager
- VP/Director/Manager Business Development
- Supplier Manager
- VP/Director/Manager Third Party Manufacturing
- VP/Director/Manager API Supply
- Outsourcing Project Manager/Specialist
- Managing Director of Global Sourcing
- VP/Director/Manager External manufacturing
