Medicago in pharma development

Preventing protein L leakage

Medicago’s Protein L Ligand Leakage ELISA kit offers pharmaceutical companies the peace of mind of knowing there is no significant protein L leakage during the purifiction process of pharmaceutical substances.

Kit packaged with Capto L
Capto L is a world-leading affinity-chromatography medium based on the immunoglobulin-binding recombinant protein L ligand. When GE Healthcare (currently Cytiva), launched Capto L in the 2010s, it was a major breakthrough in the pharmaceutical industry. Ever since its first launch, Capto L has come bundled with Medicago’s Protein L Ligand Leakage ELISA Kit as an integral part of the product. 

Eliminating undesired batch-to-batch variation
Before launching Capto L, GE Healthcare had identified the need to detect any potential leakage of protein L that might occur in the purification columns. Due to the presence of antibodies, the company had observed that there was a significant batch-to-batch variation when using their own protocol. This unnecessary extra cost, incurred at every purification run, caused GE Healthcare to act.  

Validated confirmation of leakage
The company turned to Medicago to develop a standardized kit used for the detection of protein L ligand leakage during affinity chromatography. The result: the Protein L Ligand Leakage ELISA kit, included as part of Capto L from day one. Ever since, manufacturers using Capto L as their affinity-chromatography medium have enjoyed the peace of mind of a validated confirmation of continuously low levels of protein L leakage.

Easy way to ensure production quality
With a real risk factor such as protein L leakage out of the picture, the quality of the production and finished product is ensured – eliminating the risk of impurities in the developed product along with any associated side-effects. The continuous monitoring using the kit is proof that the purification medium, and hence the production process as such, works as planned.  

Peace of mind through early warnings
Continuously monitoring and preventing the leakage of protein L is an important quality aspect in pharmaceutical production. You will conveniently be given an early warning when your affinity chromatography medium is running out or if your purification method is not optimized. An easy way to ensure that all is well in pharma purification processes.