Cell & Gene Therapy analysis

Analysis of adenovirus and other gene therapy products

Alphalyse offers a variety of services for cell and gene therapy products (GTP) and advanced therapy medicinal products (ATMPs). These include process-related impurities analysis based on mass spectrometry (MS).

Where commercial ELISA kits does not cover t...

Alphalyse offers a variety of services for cell and gene therapy products (GTP) and advanced therapy medicinal products (ATMPs). These include process-related impurities analysis based on mass spectrometry (MS).

Where commercial ELISA kits does not cover the complexity of cell gene therapies and their impurities, MS provides the identity and quantity of all individual process related impurities, including Host Cell Proteins (HCP) – even if they originate from several host species. While you would have to spend 1-2 years for development of a process-specific ELISA, you can receive an overview and details of your product impurities within weeks by applying LC-MS.

Many gene therapies consist of a virus protein capsid enclosing DNA and core proteins, and the manufacturing process applies several cell lines, such as HEK 293, Sf9, PG13, A549, BHK, CAP®, HeLa, MDCK, MRC5, NS0, PER.C6®, Sp2/0 or Vero cells. Thus, an HCP ELISA for process related impurities would have to detect proteins from multiples organisms – and would be very expensive and time-consuming to develop.

The detailed results you receive

Our LC-MS setup is suitable for products based on lentivirus, adenovirus vectors (oncolytic virus) and adeno-associated virus (AAV) vectors, and other viral vectors. In the analysis report, you receive a complete list and amounts of the viral capsid proteins and the residual protein impurities in the purified drug substance and process samples. The analysis can support gene therapy development, drug substance batch-to-batch comparison and final drug product impurity content.

All tests are performed according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. A major part of the laboratory protocol is automated to ensure fast, reproducible data acquisition, as well as the shortest project timeline possible.

Select a single analysis or combine your preferred gene therapy analysis package from the services below.

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What are gene therapy products (GTPs)?

Gene therapy products (GTPs) are a relatively new type of biopharmaceuticals, but the potential is enormous – especially with the emergence of CRISPR gene editing, which opens a new world of personalized therapies. The principle is simple: DNA is delivered into cells by a carrier, typically with either recombinant viruses or non-viral methods, to treat a genetic disease.

Which viral vectors can be used for gene therapy?

Many viral carrier systems (vectors) can be used to express or suppress a specific protein, or even kill specific cells causing e.g. cancer diseases. These typically include adeno associated (AAV), lentoviral and other retroviral, short hairpin vectors. Protein disruption often works by the process of RNA interference (RNAi), where dsRNA is delivered to cells in which siRNAs form and silence specific genes.

Why is gene therapy characterization important?

To ensure product potency, efficacy and safety, a thorough gene therapy characterization is necessary before release test and submission of an investigational new drug (IND) application - with strict CMC requirements for NDA and BLA approvals.

How do you analyze host cell proteins in gene therapy products?

The GTP characterization of e.g. AAV products is extremely complex. The disease-targeting DNA is encircled by a capsid shell consisting of viral capsid proteins. Furthermore, several host cells are typically utilized to develop the GTP. This results in a diverse group of process-related impurities, like host cell proteins, which must be detected and identified as soon as possible in process development. Luckily, mass spectrometry overcomes these obstacles and provides an HCP overview, no matter the number of host cell species.

Who is this for?

We primarily help customers within the pharmaceutical industry, and biotechs working on drug development, e.g.

Project managers

Working with process development and characterization projects.

Analytical experts

Protein scientists that work with ELISA, masss spectrometry, or CMC.

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