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[Home](https://www.sigmaaldrich.com/US/en)[Applications](https://www.sigmaaldrich.com/US/en/applications)[Pharmaceutical & Biopharmaceutical Manufacturing](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing)Gene Therapy Manufacturing
# Gene Therapy Manufacturing
Gene therapies offer an unprecedented potential to treat and cure countless diseases and conditions for which patients have no or limited treatment options. Hundreds of gene therapies are currently in development around the world, being advanced by both early-stage companies and established industry leaders.
Successful development of a gene therapy requires expertise that differs from the production of other biologics such as monoclonal antibodies. Viral vector manufacturing and specialized [testing](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-characterization-and-biosafety-testing) capabilities are unique to this modality and just two areas that can determine the success of a candidate gene therapy. The lack of established process templates, evolving regulatory guidelines, and the need to meet accelerated timelines put additional pressure on gene therapy manufacturers to get it right the first time.
Given the remarkable opportunities and challenges presented by gene therapies, alliances with experienced technology partners or contract development and manufacturing organizations ([CDMOs](https://www.sigmaaldrich.com/US/en/services/contract-manufacturing/viral-vector-manufacturing)) are essential to ensure successful process development, scale-up, manufacturing, and regulatory compliance.
Reach out to us for more details on our bioprocessing materials and technologies for viral vector production and an expert will respond back to you shortly.
[Request Information](https://www.sigmaaldrich.com/US/en/campaigns/lead-generation/viral-vector-manufacturing-solutions)
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## Related Products
Slide 1 of 8
1 of 2
[
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Millipore
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MIX0200LG05
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Mobius® MIX200L single-use mixing assembly (gold)](https://www.sigmaaldrich.com/US/en/product/mm/mix0200lg05)
Quick View
[
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SAFC
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103773
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Benzonase® Safety Plus Emprove® Expert](https://www.sigmaaldrich.com/US/en/product/mm/103773)
Quick View
[
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Millipore
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PCC100C01
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Pellicon® Capsule 0.1 m2 Ultracel® 100 kDa C Screen](https://www.sigmaaldrich.com/US/en/product/mm/pcc100c01)
Quick View
[
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Millipore
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PCC100C01C
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Pellicon® Capsule 0.1 m2 Ultracel® 100 kDa C Screen](https://www.sigmaaldrich.com/US/en/product/mm/pcc100c01c)
Quick View
[
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SAFC
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VP001
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VirusExpress® 293T Lentiviral Production Cells](https://www.sigmaaldrich.com/US/en/product/sial/vp001)
Quick View
[
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SAFC
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1.25193
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Cellvento® 4HEK Liquid](https://www.sigmaaldrich.com/US/en/product/mm/125193)
Quick View
[
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SAFC
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14385C
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EX-CELL® CD HEK293 Viral Vector Medium](https://www.sigmaaldrich.com/US/en/product/sigma/14385c)
Quick View
[
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SAFC
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VP002
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VirusExpress® 293 AAV Production Cells](https://www.sigmaaldrich.com/US/en/product/sial/vp002)
Quick View
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## Featured Categories
[](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/bioprocessing-cell-culture/bioprocessing-cell-culture-media)
[Bioprocessing Cell Culture Media](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/bioprocessing-cell-culture/bioprocessing-cell-culture-media)
Our off-the-shelf and customizable bioprocessing cell culture media (CCM) products enhance productivity in upstream mAb, vaccine, gene/cell therapy processes.
[Shop Products](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/bioprocessing-cell-culture/bioprocessing-cell-culture-media)
[](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/buffer-media-prep/media-filtration)
[Media Filtration](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/buffer-media-prep/media-filtration)
Cell culture media filtration prevents bioreactor contamination. Selection of a sterilizing filter, mycoplasma filter, or virus filter depends on process risk. Learn how to select the best filter for your cell culture media filtration.
[Shop Products](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/buffer-media-prep/media-filtration)
[](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/bioprocessing-formulation-raw-materials/upstream-process-chemicals)
[Upstream Process Chemicals](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/bioprocessing-formulation-raw-materials/upstream-process-chemicals)
Upstream process chemicals ensure superior performance of your cell culture process driving cell viability, productivity and critical quality attributes of the drug product.
[Shop Products](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/bioprocessing-formulation-raw-materials/upstream-process-chemicals)
[](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/formulation)
[Formulation](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/formulation)
Browse our high-quality excipients, with solutions for solid, liquid, semisolid, and biomolecule formulation, as well as advanced drug delivery.
[Shop Products](https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/formulation)
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Overview
Related Articles & Protocols
Support
## Gene therapy development: Grow, purify, formulate
[](https://www.sigmaaldrich.com/documents-search)
[Looking for More Specific Information?](https://www.sigmaaldrich.com/documents-search)
Visit our document search for data sheets, certificates and technical documentation.
[Find Documents](https://www.sigmaaldrich.com/documents-search)
[Shop All Gene Therapy Manufacturing Products](https://www.sigmaaldrich.com/search/gene-therapy-manufacturing?focus=products&page=1&perpage=30&sort=relevance&term=Gene%20Therapy%20Manufacturing&type=product)
## Workflow
### Viral Vector Upstream Processing
Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance
- [Learn More](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-upstream-processing)
### Viral Vector Downstream Processing
Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs
- [Learn More](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-downstream-processing)
### Viral Vector Formulation and Final Fill
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
- [Learn More](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-formulation-and-final-fill)
### Viral Vector Characterization and Biosafety Testing
Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability
- [Learn More](https://www.sigmaaldrich.com/US/en/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-characterization-and-biosafety-testing)
### Viral Vector Contract Development and Manufacturing
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization
- [Learn More](https://www.sigmaaldrich.com/US/en/services/contract-manufacturing/viral-vector-manufacturing)
Reach out to us for more details on our bioprocessing materials and technologies for viral vector production and an expert will respond back to you shortly.
[Request Information](https://www.sigmaaldrich.com/US/en/campaigns/lead-generation/viral-vector-manufacturing-solutions)
## Related Technical Articles
- [AAV Process Intensification Using High Salt Lysis and Salt Tolerant Endonuclease](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/cell-lysis-deviron-dna-digestion-benzonase)
This page describes key considerations for cell lysis and how the combination of a high salt concentration and a salt tolerant endonuclease can be used to increase vector titer and infectivity during AAV vector manufacturing.
- [Development and Optimization of a Lentivirus Manufacturing Platform](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/development-optimization-lentivirus-manufacturing-platform)
Learn how development of a suspension adapted HEK293T cell line with accompanying cell culture media can maximize lentivirus production for cell and gene therapies.
- [Lentivirus Platform: Optimizing Performance for De-Risked Production](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/lentiviral-vector-platform)
Learn how the VirusExpress® lentivirus platform utilizes DoE experiments and supplementary studies to optimize workflows, enhance yield, and ensure quality in cell and gene therapies.
- [Lentivirus Harvest Clarification Process for Cell & Gene](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/lentivirus-clarification)
Explore lentivirus harvest clarification options for viral therapy production using suspension cell lines in manufacturing platform development.
- [DNA/RNA Removal in Viral Production](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/removing-dna-and-rna-using-benzonase-endonuclease-during-viral-production)
Benzonase®endonuclease efficiently removes nucleic acid contaminants from viral production, crucial for cell and gene therapies and vaccines.
- [See All (11)](https://www.sigmaaldrich.com/US/en/search/facet-search?focus=sitecontent&term=facet-search)
### Find More Articles and Protocols
Enter Keywords
Search
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## Related Resources
- [Product Guide: Upstream Chemicals for Bioprocessing](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/402/929/upstream-productguide-pg8719en-ms.pdf)
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for classic and novel therapies, but also helps them get to market faster and simplify regulatory challenges.
- [Brochure: Draw on Our Experience: Gene Therapy Capabilities for AAV and Lentivirus Production](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/338/419/gene-therapy-capabilities-br11547en-ms.pdf)
You’ve created a gene therapy with the possibility to help patients. But the development and manufacturing of your gene therapy, how it’s developed, produced and approved, are still being outlined.
- [Application Note: One Size Does Not Fit All: Utilizing Multiple Technology Provideers in Gene Therapy Manufacturing](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/398/959/learn-to-play-nice-with-others-an9436en-ms.pdf)
Despite notable clinical and even commercial success, the demand for gene therapies still outweighs supply.
- [Technical Bulletin: Regionalizing and Democratizing Cell and Gene Therapy](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/323/304/regionalizing-and-democratizing-cell-and-gene-therapy-ts9102en-ms.pdf)
How MilliporeSigma and SaudiVax are working together to help patients in the Middle East and North Africa access the benefits of advanced medicine.
- [Application Note: Viral Vectors: Are We There Yet?](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/156/194/viral-vectors-are-we-there-yet-ms.pdf)
Looking at the current state of cell and gene therapies (CGTs), it is clear they have brought major changes to the biopharmaceutical landscape.
- [Application Note: Perspectives Of Value-Driven, Integrated Solutions In Gene Therapy](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/170/691/value-of-integrated-solutions-in-gene-therapy-ts9188en-ms.pdf)
With rapid market growth and inspiring stories of success, gene therapies boast a promising future for manufacturers and patients alike.
- [Brochure: Process Development and Drug Manufacturing: Support Services](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/428/614/br12856en-support-services-ms.pdf)
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
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## Related Videos
Slide 1 of 8
[](https://www.sigmaaldrich.com)
[Selecting The Right CMO](https://www.sigmaaldrich.com)
Partnering with a CMO may be the quickest and most efficient way to produce your therapy
[](https://www.sigmaaldrich.com)
[Reducing The Risk of Gene Therapy](https://www.sigmaaldrich.com)
Managing uncertainties can help you avoid regulatory risks
[](https://www.sigmaaldrich.com)
[3 Cost Modeling Insights to Reduce Gene Therapy Manufacturing Costs](https://www.sigmaaldrich.com)
Manufacturing costs present a key challenge to gene therapy commercialization
[](https://www.sigmaaldrich.com)
[2024 Grant Winner Customer Testimonial Video](https://www.sigmaaldrich.com)
2024 Grant Winner, Siren Biotechnology
[](https://www.sigmaaldrich.com)
[Assuring Viral Safety](https://www.sigmaaldrich.com)
Adventitious viruses may contaminate production processes
[](https://www.sigmaaldrich.com)
[Efficient DNA Clearance](https://www.sigmaaldrich.com)
Benzonase® nuclease efficiently digests DNA and RNA into fragments smaller than 5 base pairs
[](https://www.sigmaaldrich.com)
[Start Right to Scale Right](https://www.sigmaaldrich.com)
Successfully scale your gene therapy production by implementing a platform process from the start.
[](https://www.sigmaaldrich.com)
[SF-RVN® Platform](https://www.sigmaaldrich.com)
For Improving the Safety Profile of Your Bioprocesses
## How Can We Help
In case of any questions, please submit a [customer support request](https://www.sigmaaldrich.com/US/en/support/customer-support)
or talk to our customer service team:
Email [custserv@sial.com](mailto:custserv@sial.com)
or call +1 (800) 244-1173
## Additional Support
- [Chromatogram Search](https://www.sigmaaldrich.com/chromatogram-search)
Use the Chromatogram Search to identify unknown compounds in your sample.
- [Calculators & Apps](https://www.sigmaaldrich.com/US/en/support/calculators-and-apps)
Web Toolbox - science research tools and resources for analytical chemistry, life science, chemical synthesis and materials science.
- [Customer Support Request](https://www.sigmaaldrich.com/US/en/support/customer-support)
Customer support including help with orders, products, accounts, and website technical issues.
- [FAQ](https://maestro.my.site.com/knowledgeportal/s/)
Explore our Frequently Asked Questions for answers to commonly asked questions about our products and services.
* * *
__Featured Articles__
[AAV Process Intensification Using High Salt Lysis and Salt Tolerant Endonuclease](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/cell-lysis-deviron-dna-digestion-benzonase)
This page describes key considerations for cell lysis and how the combination of a high salt concentration and a salt tolerant endonuclease can be used to increase vector titer and infectivity during AAV vector manufacturing.
[Development and Optimization of a Lentivirus Manufacturing Platform](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/development-optimization-lentivirus-manufacturing-platform)
Learn how development of a suspension adapted HEK293T cell line with accompanying cell culture media can maximize lentivirus production for cell and gene therapies.
[Lentivirus Platform: Optimizing Performance for De-Risked Production](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/lentiviral-vector-platform)
Learn how the VirusExpress® lentivirus platform utilizes DoE experiments and supplementary studies to optimize workflows, enhance yield, and ensure quality in cell and gene therapies.
[Lentivirus Harvest Clarification Process for Cell & Gene](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/lentivirus-clarification)
Explore lentivirus harvest clarification options for viral therapy production using suspension cell lines in manufacturing platform development.
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