Newsletter January 2012 from Kromasil

KromaNews:Prep & Production

Outsourced production – an opportunity for CMOs

Major changes are occurring in the development of new therapeutics within large pharmaceutical and biotechnology companies. These companies are becoming leaner and rely more on outsourcing, anything from analytical methods to full-scale contract production. With the change in paradigm there is a need for contract manufacturers (CMOs) to expand their services and guarantee quality work. Experience allows for contract manufacturing companies to deliver anything from robust analytical methods to purified APIs at a reasonable cost.

Kromasil – an asset in the paradigm shift

The importance of a chemically stable HPLC packing material

In preparative chromatography it is of uttermost importance that all parameters are optimized to give the lowest possible cost for the target substance purified. We have in previous articles described the importance of optimization of the HPLC separation. However, another factor that could greatly influence your separation cost is the lifetime of the packing material. To run the separation using a stable packing material will not only result in a lower cost due to a longer lifetime of the packing material, but the separation can also be run with less disturbances, with more stable conditions for a long time.

Acidic or alkaline attack – what is happening

Why you can't have your cake and eat it too

In order to develop a successful preparative HPLC method one first needs to define relevant goals for the specific purification. The most important and common parameters defining the quality of a separation is loading (defined as m_crude/m_resin), purity and yield. Purity is usually already defined by regulatory agencies (such as FDA or equivalent) and often includes area percentage of product as well as individual impurities, while yield simply is the ratio of purified product divided by amount loaded onto the column.

Which is your part?