Cell & Gene Therapy analysis

Detailed analysis of non-standard proteins in one assay

Are you seeing 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 ther...

Are you seeing 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, 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, retrovirus, 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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Infographic: Towards consistent C&GTs

77% of C&GTs industry leaders worry that process development and optimization challenges will prevent them from achieving commercial manufacture.

This overview of the analytical tools for investigating process consistency will assist you in selecting the techniques that will help you ensure a safe product.

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LC-MS gives the identity and quality of all the proteins

Featured Video

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

LC-MS gives the identity and quality of all the proteins

See what our customers have to say

  • Testimonial: We can now monitor the consistency of our viral capsid formations
  • Testimonial: I found them knowledgeable, easy to work with, and helpful
  • Testimonial: We found out why our PG13 ELISA had such low coverage of our gene therapy's HCPs
  • Testimonial: Extremely professional service, high-level quality, excellent communication
  • Testimonial: We use LC-MS to follow the reduction of specific A549 HCPs

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