Process Development in China at CARBOGEN AMCIS + Case Study

What are the major tasks for the Shanghai Development team?

„The Shanghai site has a focus on contract manufacturing service, therefore the major tasks for the development team are technology transfer and process development to support GMP production. In such sense, our job is to make the manufacturing process simpler, robust and to keep it reproducible to ensure a stable process and consistent good quality of the product.“

What are the greatest challenges for your team?

„The group has positioned Shanghai as a site that specializes in large scale manufacturing of API and intermediates under GMP. Therefore, most of the projects we take are in transition from early phase to last phase. A common issue of these projects is that they often come with excessive in-process controls. It is completely reasonable that in early phase one may apply more in-process measures to gain better control and to have better understanding of process at scale. When a project evolves entering late phase and process performance is better understood, other KPIs such as process economy and throughput should be considered. However, it is always a challenge to convince the customer to reduce such control measures. The removal or streamline of in-process controls (IPC) at CARBOGEN AMCIS is performed by risk base approach - data of history batches including result of the IPC to be removed, analytical data and yield of corresponding batch will be collected; impact of product quality will be assessed; a proof of concept R&D run will be performed as demonstration; finally a change control will be initiated and presented to customer for approval.“

What are your responsibilities as Senior Head of Development at CARBOGEN AMCIS Shanghai?

As the head of the development department, my first priority is to build an effective and stable team with a group of trained chemists and project managers to support the operation and business expansion of the Shanghai site. To make our customer satisfied, we need to deliver our products and services in high quality and in time. An equally important responsibility for me is to ensure the project managers maintain focused on the team’s goal and keep good communication with our customers to make the team working toward its objective.

Case Study

In a project entering phase 3 from phase 2 where there were many IPCs designed to monitor the waste streams, we successfully convinced the customer to remove 4 IPCs in a single step by the mentioned approach. The campaign gave product in similar quality and yield and batch time was much shortened.