Gene Therapy Product analysis

Analysis of adenovirus and other gene therapy products

Alphalyse offers a variety of services for your gene therapy product (GTP), a type of advanced therapy medicinal products (ATMPs). Among those is our Host Cell Protein analysis based on mass spectrometry (MS).

Where commercial ELISA kits cannot cover the complexity of gene therapy products and their HCP profile, MS provides you with the identity and...

Alphalyse offers a variety of services for your gene therapy product (GTP), a type of advanced therapy medicinal products (ATMPs). Among those is our Host Cell Protein analysis based on mass spectrometry (MS).

Where commercial ELISA kits cannot cover the complexity of gene therapy products and their HCP profile, MS provides you with the identity and quantity of all individual HCPs in the product – even if the HCPs originate from several host species. While you would have to wait 1-2 years for a process-specific ELISA to be developed, you can receive an overview of your product’s HCPs within weeks by applying LC-MS to your early harvest sample or null-cell line.

Many gene therapies consist of an extensive protein capsid enclosing the DNA and core proteins, thus having a high number of surface proteins that require characterization by a highly sensitive approach. Furthermore, the manufacturing process of some GTPs include using multiple cell lines and even human cells in combination with non-human cells. Thus, an ELISA would have to be incredibly elaborate – and would thus become expensive – to cover a fraction of HCPs in these products.

The detailed results you receive

Our analytical setup is especially suitable for products based on adenovirus vectors (oncolytic virus) and adeno-associated virus (AAV) vectors, but not limited to these. With the results, you receive a complete characterization of the viral capsid proteins and the residual protein impurities that arise during process development. The analysis can support your whole process, including gene therapy development, batch-to-batch comparison and final drug product validation.

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 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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