How Consistent API quality can be achieved through crystallization know-how and high level of process automation
One of the key requirements of pharmaceutical companies is to produce consistent and reliable API's without unexpected problems during manufacturing. Nowhere are these problems more serious than in the production of HPAPI's.
However sometimes drug product failures arise, these are obviously both costly for the producer and if not identified potentially dangerous to consumers. As a result pharmaceutical companies must take every precation and opportunity to avoid these incidents.
Some of these problems are caused by unintentional changes of the physical parameters of active pharmaceutical ingredient and during this webinar we will aim to show that these failures are possible to avoid through the utilization of carefully optimized crystallization processes and highly automated manufacturing equipment.
This presentation will cover: Development and optimization of a robust manufacturing processes, cost effective and optimized processes (DoE), 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, reduction 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.
Presented by
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.
