HPAIs Expertise: Process Development

Highly Potent Active Ingredients: Process Development

Novasep experts develop effective purification processes and synthesis services for highly potent molecules to answer your needs:

• process development and scale-up
• production of preclinical and clinical batches
• preparation of reference compounds, analytical standards, metabolites
• analytical methods development
• stability studies
• processes and methods validation

Benefits and Advantages

Optimized Processes

Novasep Synthesis offers to you its broad expertise to optimize synthesis and purification and to define the most efficient processes in terms of cycle time, yield and purity.

Furthermore processes are continuously improved, taking into account safety, regulatory requirements and environmental protection.

We are committed to provide solutions to your needs in an efficient and timely manner.

Our objective is to work in close cooperation with your scientists in order to satisfy your demands.

Scale-up and Production

Our versatile Labs and Kilo-Labs allow us to scale up processes and also produce clinical batches for HPAIs. Batch size may vary from mg to kg involving several chemical and purification steps.

The process and product development group is supported by our highly skilled analytical development team. This team is able to develop new methods or fine tune existing methods for intermediates and APIs.

Confidentiality

All projects are handled under strict confidentiality with respect to all safety, health and environmental regulations.