Newsletter May 2012 from Kromasil

KromaNews:Prep & Production

HPLC, a rapid development and a robust
production process to purify APIs

With over 25 years of expertise in the development of preparative chromatography equipment and purification processes, Novasep has pioneered the field of industrial HPLC including both batch and continuous (SMB) technologies. Within recently extended facilities in Shanghai, the company offers process development and scale-up services for the production of APIs under cGMP conditions.

HPLC technology available worldwide

Kromasil preparative HPLC applications – success stories
1. Purification of insulin

Kromasil packing media are today the dominating materials used for large-scale production of human insulin and variants, among many other applications. Multi-ton volumes of Kromasil per year are used globally to produce these APIs, with high purity demands.
This article will show an example of the development work that has been performed to facilitate cost-effective processes for the final purification of human insulin, and to service our customers in order to lower their costs.

Pushing off impurities

Scaling methodology in preparative batch HPLC

One of the beauties of purification using preparative HPLC is the simplicity of how scaling of a separation process is made. This article will give you an insight into how this is done, and which difficulties may occur.

Get a clue: scale by yourself!