Tools & Technologies Showcase: NanoMosaic Tessie™ Platform for Advanced AAV Analytics
At Andelyn Biosciences, we continuously assess and implement advanced analytical technologies to enhance data quality, accelerate development timelines, and meet evolving regulatory requirements. The NanoMosaic Tessie™ platform is a recent addition to our analytical tools, allowing high-resolution characterization of AAV vectors throughout development and manufacturing.
Following its recent FDA Center for Biologics Evaluation and Research (CBER) Advanced Manufacturing Technology (AMT) designation, NanoMosaic’s platform is increasingly recognized as a next-generation solution for gene therapy analytics.
Precision Analytics for Complex Modalities
Characterizing AAVs requires more than just quantifying total particles; it requires a deep understanding of the relationship between the capsid and its genetic payload. Traditional analytical methods often require a "trade-off" between speed and depth of insight. By utilizing high-resolution multiplexing, our scientists can now bypass many of these historical bottlenecks.
At Andelyn, this technology enables us to:
- Assess Partial Genomes: The real power of this system is that you can assess how partial the genomes are. Rather than just separating into full-length and partial-length, you can semi-quantitatively gauge the amount of truncation using different primers.
- Analyze Early and Often: Because this platform is compatible with in-process samples, Andelyn can monitor quality attributes in the upstream phase rather than waiting for final purification.
Aligning with Modern Regulatory Standards
The recent FDA AMT designation for this technology underscores a broader industry shift toward "quality by design." By adopting and validating these tools within our facilities, Andelyn provides our partners with data that is not only highly precise but also aligns with the FDA’s preference for direct measurement of Critical Quality Attributes (CQAs).
This proactive approach to adopting technology aims to minimize regulatory obstacles. When our partners submit IND or BLA filings, they do so with a comprehensive analytical package supported by some of the most advanced tools currently available in the cell and gene therapy (CGT) ecosystem.
Why Depth of Insight Matters
Data-rich analytics serve as the bridge between a promising candidate and a successful clinical product. By investing in tools that deliver same-day results and molecular-level quantification of transgene integrity, Andelyn can:
- Accelerate Process Development: Faster iterations based on real-time packaging data.
- Mitigate Risk: Identifying transgene "breaking points" or vulnerabilities early in the manufacturing lifecycle.
- Enhance Consistency: Ensuring that every batch meets the rigorous standards required for patient safety.
Enabling Data-Driven Gene Therapy Development
By integrating NanoMosaic’s advanced analytical platform, Andelyn strengthens its ability to deliver high-quality, data-rich insights for AAV gene therapy programs. The combination of multiplexed analysis, reduce dassay complexity, and regulatory alignment supports more efficient development pathways and improved product characterization.
As regulatory expectations continue to evolve, technologies that directly measure critical quality attributes will play an increasingly important role in advancing gene therapies from early development through commercialization.
If you’d like to learn more about Andelyn’s tools and technologies, reach out to us.
If you’d like to learn more about NanoMosaic’s FDA AMT-designated Tessie™ platform, visit the NanoMosaic website.
At Andelyn Biosciences, we continuously assess and implement advanced analytical technologies to enhance data quality, accelerate development timelines, and meet evolving regulatory requirements. The NanoMosaic Tessie™ platform is a recent addition to our analytical tools, allowing high-resolution characterization of AAV vectors throughout development and manufacturing.
Following its recent FDA Center for Biologics Evaluation and Research (CBER) Advanced Manufacturing Technology (AMT) designation, NanoMosaic’s platform is increasingly recognized as a next-generation solution for gene therapy analytics.
Precision Analytics for Complex Modalities
Characterizing AAVs requires more than just quantifying total particles; it requires a deep understanding of the relationship between the capsid and its genetic payload. Traditional analytical methods often require a "trade-off" between speed and depth of insight. By utilizing high-resolution multiplexing, our scientists can now bypass many of these historical bottlenecks.
At Andelyn, this technology enables us to:
- Assess Partial Genomes: The real power of this system is that you can assess how partial the genomes are. Rather than just separating into full-length and partial-length, you can semi-quantitatively gauge the amount of truncation using different primers.
- Analyze Early and Often: Because this platform is compatible with in-process samples, Andelyn can monitor quality attributes in the upstream phase rather than waiting for final purification.
Aligning with Modern Regulatory Standards
The recent FDA AMT designation for this technology underscores a broader industry shift toward "quality by design." By adopting and validating these tools within our facilities, Andelyn provides our partners with data that is not only highly precise but also aligns with the FDA’s preference for direct measurement of Critical Quality Attributes (CQAs).
This proactive approach to adopting technology aims to minimize regulatory obstacles. When our partners submit IND or BLA filings, they do so with a comprehensive analytical package supported by some of the most advanced tools currently available in the cell and gene therapy (CGT) ecosystem.
Why Depth of Insight Matters
Data-rich analytics serve as the bridge between a promising candidate and a successful clinical product. By investing in tools that deliver same-day results and molecular-level quantification of transgene integrity, Andelyn can:
- Accelerate Process Development: Faster iterations based on real-time packaging data.
- Mitigate Risk: Identifying transgene "breaking points" or vulnerabilities early in the manufacturing lifecycle.
- Enhance Consistency: Ensuring that every batch meets the rigorous standards required for patient safety.
Enabling Data-Driven Gene Therapy Development
By integrating NanoMosaic’s advanced analytical platform, Andelyn strengthens its ability to deliver high-quality, data-rich insights for AAV gene therapy programs. The combination of multiplexed analysis, reduce dassay complexity, and regulatory alignment supports more efficient development pathways and improved product characterization.
As regulatory expectations continue to evolve, technologies that directly measure critical quality attributes will play an increasingly important role in advancing gene therapies from early development through commercialization.
If you’d like to learn more about Andelyn’s tools and technologies, reach out to us.
If you’d like to learn more about NanoMosaic’s FDA AMT-designated Tessie™ platform, visit the NanoMosaic website.
At Andelyn Biosciences, we continuously assess and implement advanced analytical technologies to enhance data quality, accelerate development timelines, and meet evolving regulatory requirements. The NanoMosaic Tessie™ platform is a recent addition to our analytical tools, allowing high-resolution characterization of AAV vectors throughout development and manufacturing.
Following its recent FDA Center for Biologics Evaluation and Research (CBER) Advanced Manufacturing Technology (AMT) designation, NanoMosaic’s platform is increasingly recognized as a next-generation solution for gene therapy analytics.
Precision Analytics for Complex Modalities
Characterizing AAVs requires more than just quantifying total particles; it requires a deep understanding of the relationship between the capsid and its genetic payload. Traditional analytical methods often require a "trade-off" between speed and depth of insight. By utilizing high-resolution multiplexing, our scientists can now bypass many of these historical bottlenecks.
At Andelyn, this technology enables us to:
- Assess Partial Genomes: The real power of this system is that you can assess how partial the genomes are. Rather than just separating into full-length and partial-length, you can semi-quantitatively gauge the amount of truncation using different primers.
- Analyze Early and Often: Because this platform is compatible with in-process samples, Andelyn can monitor quality attributes in the upstream phase rather than waiting for final purification.
Aligning with Modern Regulatory Standards
The recent FDA AMT designation for this technology underscores a broader industry shift toward "quality by design." By adopting and validating these tools within our facilities, Andelyn provides our partners with data that is not only highly precise but also aligns with the FDA’s preference for direct measurement of Critical Quality Attributes (CQAs).
This proactive approach to adopting technology aims to minimize regulatory obstacles. When our partners submit IND or BLA filings, they do so with a comprehensive analytical package supported by some of the most advanced tools currently available in the cell and gene therapy (CGT) ecosystem.
Why Depth of Insight Matters
Data-rich analytics serve as the bridge between a promising candidate and a successful clinical product. By investing in tools that deliver same-day results and molecular-level quantification of transgene integrity, Andelyn can:
- Accelerate Process Development: Faster iterations based on real-time packaging data.
- Mitigate Risk: Identifying transgene "breaking points" or vulnerabilities early in the manufacturing lifecycle.
- Enhance Consistency: Ensuring that every batch meets the rigorous standards required for patient safety.
Enabling Data-Driven Gene Therapy Development
By integrating NanoMosaic’s advanced analytical platform, Andelyn strengthens its ability to deliver high-quality, data-rich insights for AAV gene therapy programs. The combination of multiplexed analysis, reduce dassay complexity, and regulatory alignment supports more efficient development pathways and improved product characterization.
As regulatory expectations continue to evolve, technologies that directly measure critical quality attributes will play an increasingly important role in advancing gene therapies from early development through commercialization.
If you’d like to learn more about Andelyn’s tools and technologies, reach out to us.
If you’d like to learn more about NanoMosaic’s FDA AMT-designated Tessie™ platform, visit the NanoMosaic website.