Cell & Gene Therapy analysis

Do you see all process-related protein impurities in your product?

The challenges of analyzing process-related impurities facing cell and gene therapy (C&GT) developers are unique and remarkably complex. ELISA and other standard assay techniques simply can’t unlock the knowledge needed for you to have complete confidence in your therapy.

Now, Alphalyse is delivering a new era of process-related impurity analysis based on mass spectrometry (LC-MS). We developed unique solutions that finally make LC-MS analysis easy to access – and it is fast becoming the ‘must-have’ technique.

Bringing absolute clarity to protein impurity analysis

Within weeks, one assay unlocks the identity and quantity of all proteins – irrespective of the source, even if they originate from several host species. The data allows you to understand and control the purification process – to ensure consistent product quality, purity, regulatory compliance, and ultimately patient safety.

The assay is applicable for products based on lentivirus, retrovirus, adenovirus (oncolytic virus), adeno-associated virus (AAV) vectors, bacteriophages (phage therapy), and more.

It works for cell lines such as HEK 293, Sf9, PG13, A549, BHK, CAP®, HeLa, MDCK, MRC5, NS0, PER.C6®, Sp2/0, Vero, S. aureus, P. aeruginosa, A. baumannii, etc.