GEN-MKT-18-7897-A
May 7, 2020 | Biopharma, Blogs, Pharma | 0 comments
For many of you working to develop gene therapy drugs, you know that the time to market the drug is critical. Because gene therapeutics cure diseases by targeting specific genes, it is a constant race to see who develops the drug first. Unlike other classes of drugs where multiple medications can be used to treat a disease, whoever is first to develop a gene therapy drug wins.
When it comes to adeno-associated virus-based gene therapies, there is a lack of reliable and reproducible methods to consistently produce them. One of the key challenges you face when analyzing AAVs is determining whether the therapeutic transgene payload has been successfully incorporated into the AAV vector product.
During the manufacturing of AAV vectors, capsids containing the full payload of transgenes are produced. There is also a high percentage of capsids that might not incorporate any of the transgenes (empty), or contain fragments of the transgene (partial), that are produced as well. The presence of these impurities could increase immunogenicity or inhibit transduction of full capsids by competing for vector binding sites on cells. That is why successful incorporation of the transgene is critical for the efficacy and safety of gene therapies.
SCIEX has developed a breakthrough analytical method that is able to detect with great precision whether the AAV capsids are full, partially full or empty.
You will discover:
This is instrumental in improving and streamlining the development and production process for your AAV-based therapeutics. By giving you the right analytics, you will be able to develop better quality and safer products, all while reducing the cost to manufacture.
With the prospect of shorter analysis time and better analytics, request a copy of our technical note dedicated to teaching you all about our novel method. Find out how you can improve your drug development process with this method now.
As therapeutic pipelines continue to diversify, bioanalysis is being asked to do more than ever before. From small molecules to complex biologics, today’s scientists must generate high‑quality, reliable data across a growing range of molecule types and workflows, often under increasing time pressure.
Regulated laboratories are evolving faster than ever. New analytical modalities, higher sample throughput, increasing regulatory scrutiny, and leaner teams are reshaping how work gets done. At the same time, expectations for data integrity, standardization, and operational efficiency continue to increase complexity and/or scope. In this environment, LC-MS software is no longer simply an instrument control platform—it has become a critical part of a laboratory’s quality management system. The question is no longer whether your lab has changed, but whether your software has evolved to support the way regulated labs operate today, and if they are ready and able to meet the demands, they will face tomorrow.
Analyst software has long been a trusted foundation in regulated LC-MS laboratories—and for many, it still performs reliably today. But regulated environments are evolving faster than ever. As labs transition to Windows 11, strengthen cybersecurity policies, modernize IT infrastructure, and prepare for future compliance expectations, software decisions are no longer just about what works today—they’re about managing tomorrow’s risk. Analyst will not be supported on Windows 11. While some labs may continue operating in unsupported environments temporarily, the bigger question is: when that risk becomes reality, will your lab be reacting under pressure—or executing a planned mitigation strategy with confidence?
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