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Streamlining AAV analytics in gene therapy manufacturing workflows

AAV analytics in GMP-regulated environments

 

AAV manufacturing environments are GMP-regulated and subject to a series of rules established by agencies  such as the US Food and Drug administration (FDA) and the European Union (EU). These regulations require that any software used in AAV manufacturing workflows have features that ensure data traceability and reproducibility.  In addition, instruments to be used within AAV manufacturing processes need to be qualified at different stages of production and implementation. These qualifications include design, installation and operational qualifications (DQ, IQ, OQ).

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New AAV analytical technology now available for use in AAV manufacturing workflows

SamuxMP, the mass photometer tailored for AAV analytics, can be used in GMP-regulated environments as it has a compliant software that fulfills the FDA and EU requirements for AAV manufacturing including:

 

  • User management and access control, including several privilege levels

  • Full data traceability, unique ID assigned for each raw dataset

  • Detailed audit trail and electronic signatures for full accountability

 

 

The Refeyn service teams also provide installation and operational qualifications for instruments destined to AAV manufacturing facilities, including documentation and training upon request

Streamlined, reproducible workflows for AAV characterization in GMP-regulated environments

Refeyn’s software package for AAV manufacturing environments includes automated workflows to streamline data analysis, as well as standardize it between operators. In the automated mode, mass ranges are automatically defined to classify detected AAVs into empty, full and partially filled populations.

 

These ranges are automatically defined based on user inputs for the expected mass of the empty capsids and the size of the genomic payload. Manual and semiautomated modes are also available for users with advanced permissions.

Image: Three measurements of an AAV sample using an automated workflow that detects empty, full and partially filled AAV capsids

Three measurements of an AAV sample using an automated workflow that detects empty, full and partially filled AAV capsids

Find out how to implement mass photometry in AAV manufacturing environments

Application of mass photometry in GMP-regulated environments for characterization of AAV samples

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Read this whitepaper to learn how the Samux software package for GMP-regulated environments complies with GMP manufacturing regulations. Find out the main components of the GMP software package and their features. See detailed information on how the Samux software package for GMP provides user management and access, audit trails, electronic signatures and individually traces every dataset. Finally, find data showcasing the automated workflow that detects empty, full and partially filled AAV capsids in a sample based on basic user input.

Additional resources​

WEBINAR

Harnessing mass photometry for AAV sample characterization in GMP-regulated environments

In this webinar, Cátia Crespo from Refeyn, explains how mass photometry can be now applied to manufacturing workflows for AAV-based gene therapies. She discusses how Refeyn’s new software solutions, address all the US & EU regulatory requirements, including user management, audit trails and signing options when exporting files from Refeyn software applications.

Announcement for the webinar on the Samux GMP software for AAV manufacturing, featuring Cátia Crespo
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BLOG POST​

Blog: Comparing analytical approaches for AAV characterization

 

Read this blog post to learn how mass photometry compares to other AAV analytical methods for empty/full AAV measurements, and why it is an ideal technique for AAV manufacturing.

To learn more about how mass photometry can streamline your AAV sample characterization workflows

More Application Notes

Browse through our catalogue of application notes highlighting some recent case studies featuring mass photometry.

Investigating lentivirus titer with macro mass photometry

 

Mass photometry supports membrane protein purification protocols 
 

Characterizing protein oligomerization with automated mass photometry

Quantifying heterogeneous AAV capsid loading using mass photometry
 

Download the application note

Streamlining AAV analytics in gene therapy
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