Monitoring protein L leakage

Medicago’s Protein L Ligand Leakage ELISA kit offers pharmaceutical companies an easy means of confirming significant protein L leakage during chromatographic purification of pharmaceutical substances.

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, this was a major breakthrough in the pharmaceutical industry. Ever since its launch, Capto L comes 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 leakage of protein L occuring in purification columns. As GE relied on an antibodies in their previous approach, the company observed significant batch-to-batch variation when using their own protocol. This unnecessary extra cost, incurred per purification run, caused GE Healthcare to initiate development of a more consistent detection method.  

‍Validated confirmation of leakage
GE Healthcare subsequently turned to Medicago for help in developing a standardized kit to detect protein L ligand leakage during affinity chromatography purifications. The result came in the form of Medicago's Protein L Ligand Leakage ELISA kit, including Capto L. Since the kit's inception, manufacturers using Capto L as their affinity-chromatography medium have enjoyed the easy 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.