Gene & Cell Therapy analysis

Detailed analysis of non-standard proteins in one assay

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 ...

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, and even if they originate from several host species. The data allows you to understand and control the purification process – for ensuring consistent product quality, purity, regulatory compliance, and ultimately patient safety.

The assay is applicable for products based on lentivirus, adenovirus (oncolytic virus), adeno-associated virus (AAV) vectors, 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, etc.

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Insights

‘Ensuring consistency of C&GTs is complex. We offer proven technology you can trust and you’re in safe hands with our LC-MS experts.’

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Featured Video

This case video shows how a product utilizing a lentivirus vector and expressed in HEK293 T cells was characterized using mass spectrometry.

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