Newsletter September 2012 from Kromasil

KromaNews:Prep & Production

Pharmaceutical company uses Kromasil's method development expertise to improve productivity in its purification process

In recent years, India has proven to be an area of strong growth in the peptide market. Numerous Indian companies are developing biosimilars while several others are focusing on research and development (R&D) of novel therapeutic peptides. Issar Pharmaceuticals, located in the Hyderabad, India is an example of a company that has specialized in providing novel therapeutic peptides. The company has successfully synthesized a number of promising peptides in its pipeline, most notably being the Melgain^®, which was commercialized in 2004.

Important aspects of design and process scale up

Kromasil preparative HPLC applications – success stories
2. Purification of orlistat

Obesity has developed into a severe, global health problem during the last decades, and as a result pharmaceutical companies have tried to develop a remedy for obesity, that can be used in combination with dieting and physical exercise. The one medication currently available and approved for long-term use is an anti-obesity drug marketed as Xenical or Alli. The API in the drug is Orlistat, also known as tetrahydrolipstatin.

See how the separation of Orlistat can be improved!

The importance of overloading studies in method development
– a case study

Preparative HPLC differs from analytical HPLC since it needs to be performed in the nonlinear part of the adsorption isotherm in order to maximize important parameters such as column loading and productivity. In preparative HPLC, method development screening is commonly performed with analytical injections. This makes it possible to establish and compare selectivity in different chromatographic systems. From the screening, one or more candidate phases are selected for a closer preparative study with overloaded injections. This case study illustrates the risk of relying only on selectivity during preparative method development.
The scope of the study was to separate an API (Mw ≈ 900 g/mol) from its impurities and achieve 99.0% purity with as high productivity as possible.

Don't miss that in your development study

Kromasil - Gold Sponsor at SPICA 2012

Are you heading for SPICA in Brussels this year?

Don't miss our vendor seminar on Tuesday, 12:15 - 13:15 in meeting room 211, or meet us for a chat in booth #1.