Gene Therapy Product analysis

Analysis of adenovirus and other gene therapy products

Alphalyse offers a variety of services for your gene therapy product, a type of advanced therapy medicinal products (ATMPs). The 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 ...

Alphalyse offers a variety of services for your gene therapy product, a type of advanced therapy medicinal products (ATMPs). The 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 impurities that arise during process development.

All tests are performed according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

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

MoreLess details

Start the collaboration

We offer customized solutions, contact us to discuss your project.

Ask a question or get a quote

Send us a description of your project and we shall be happy to present you with a solution.





Attach a file (Optional)
Select file

Set up a phone meeting

We encourage you to call us or schedule a meeting to discuss your project in detail.

Set up meeting

Direct phone numbers

More info

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.

A wide range of viral carrier systems (called viral vectors) can be used to either 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 are then formed to silence specific genes.

To ensure product potency, efficacy and safety, a thorough gene therapy characterization is necessary before release testing and submission of the investigational new drug (IND) application to FDA and EMA with their strict CMC requirements for both NDA and BLA approvals. 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. Traditional impurity analysis and HCP coverage methods cannot be use due to the complex host cell protein profile. 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.

Experts

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

Sign up for the newsletter
Subscribe to get 3 tips that will instantly improve your protein analysis results

Receive monthly emails with news, tips, case stories
and offers for protein analysis
Private, secure, spam-free
© Copyright Alphalyse 2002 - 2020. All rights reserved.