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Lentivirus Production for Cell and Gene Therapy
Research to clinical
To streamline your transition from research to clinical scale, we now offer a complete suspension lentiviral vector production system that produces high titers (greater than 1 x 108 TU/mL unconcentrated). A smooth ramp-up from research grade lentiviral vector production to clinical production is essential. To accelerate your development timelines and ease the transition, we offer complementary research-grade and GMP solutions for ONE complete solution from research through clinical and commercial production.
Figure 1. Comparison of LV titers between research-grade and CTS (clinical) reagents. LV vectors were produced in a 30 mL format in 125 mL shaker flask system. Performance of the LV-MAX Lentiviral Production System was shown to be equivalent to the CTS LV-MAX production system as measured by viral titers determined by transduction of HT1080 cells and flow cytometry analysis of GFP-positive cells.
Our products are backed by our global scale, regulatory and technical support teams, an unrelenting focus on quality, and decades of experience with Good Manufacturing Practices (GMP). The LV-MAX Lentiviral Production System is available in both a research grade and Gibco CTS format. The Gibco CTS LV-MAX Lentiviral production system is manufactured in conformity with current GMP for medical devices (21 CFR Part 820) and follows USP <1043>** and European Pharmacopoeia (Ph. Eur.) 5.2.12 recommendations. All CTS products come with a Drug Master File or a Regulatory Support File.
| Attributes | LV-MAX | CTS LV-MAX |
|---|---|---|
| Intended use | For research only | For research use or manufacturing of cell, gene, or tissue-based products |
| Pack sizes | Starter kit (300 mL) | >10 L |
| Formulation | Same | Same |
| Performance | Same | Same |
| Packaging cell line | Research use | GMP-banked HEK293 Extensive cell line development |
| Regulatory support documentation | None | DMF Regulatory Support File |
| GMP quality | Manufactured to ISO 9001 or ISO 13485 | Manufactured to ISO 13485 21 CFR Part 820/USP <1043> |
Scale up with confidence
As more cell and gene therapies enter into the clinical and commercial space, there is an emerging need for more cost-effective and scalable viral vector manufacturing platforms, such as lentiviral vector production.
As the world leader in serving science, Thermo Fisher Scientific delivers innovative solutions to accelerate the development of lentivirus production to help advance the field of cell and gene therapy. With solutions that span the entire LV workflow, we provide high-quality products and expertise to help companies develop breakthrough cell and gene therapies.
The LV-MAX Lentiviral Production System is designed to support robust lentiviral production in a variety of suspension culture vessels. You can scale up or down based on your needs for greater throughput early in discovery or for seamless and efficient clinical scale-up while maintaining high yield in a serum-free system (Figure 1). Regardless of scale, you can produce with more confidence.
Figure 2. LV vector was produced in different culture formats using the LV-MAX Lentiviral Production System.
The lentiviral titer was determined by transducing HT1080 cells and analyzing GFP-positive cells. Analysis of data showed no statistical significance between titers among the different production formats.
Download the App Note for scalability of the CTS LV-MAX Lentiviral Production System in bioreactors
Download the App Note for scaling up Lentiviral production to 50L
Our commitment to quality
Our products are backed by our global scale, our regulatory and technical support teams, an unrelenting focus on quality, and decades of experience with good manufacturing practices (GMP). This winning combination has enabled us to become a chosen partner of many top 50 biopharmaceutical companies worldwide. All our manufacturing sites have independently been certified by the Quality Management Systems (ISO 9001 and/or ISO 13485). Gibco CTS LV-MAX Lentiviral Production System is manufactured in conformity with GMP for medical devices (21 CFR Part 820) and follows USP <1043>* and European Pharmacopoeia (Ph. Eur.) 5.2.12 recommendations. All CTS products come with a Drug Master File in the USA/CAN/JP or a Regulatory Support File in other regions.
We are dedicated to your commercial success and that is why we are continuing to develop new lentiviral production solutions and invest in our GMP manufacturing. Our commitment to quality systems and materials, redundant manufacturing, and continuity of supply is upheld through our supply agreements, risk assessment, and mitigation strategies. Utilizing these practices enables our customers to be successful, helping clear the path to commercialization. Our mission is to help you meet current and future viral vector demand and clear the path to commercialization to help you stay at the forefront of cell and gene therapy.
NEW GMP banked HEK 293 cells for viral vector production
CTS Viral Production Cells are derived from the human embryonic kidney (HEK) 293 cell line and were adapted to suspension culture in a chemically defined medium. These cells were developed to support cell and gene therapy applications, particularly intended for viral vector manufacturing. To comply with recent FDA CMC guidance for Human Gene Therapy INDs, CTS Viral Production Cells do not contain SV40 large T antigen nor have they been genetically engineered. With detailed cell line lineage documentation and extensive quality control testing, you can seamlessly transfer these GMP cells to clinical production. These cells are optimized to culture in suspension with the CTS LV-MAX Production Medium. For more information on this cell line, please contact outlicensing@thermofisher.com.
- Fully documented cGMP-banked cell line (HEK 293F derived) with detailed cell line lineage history
- Absence of SV40 large T antigen
- Supports >10 million cells/mL in chemically-defined medium
Ordering information for LV-MAX kits and components
Do you have GMP-banked cells that can be used for clinical work and IND filing?
Yes, we offer cGMP-banked viral production cells that have been characterized according to ICH Q5a guidance.
Is my LV-MAX transfection reagent missing a plastic seal around its lid?
The LV-MAX transfection reagent does not come with an external plastic cap seal. This avoids exposing the final product to temperature fluctuations experienced during the seal application process. This does not indicate a breach in container closure integrity.
Are the cells clonally expanded?
Viral Production Cells are derived from Freestyle 293-F cells (Cat. No. R79007). The cells were adapted to high-density culture and subsequently adapted for growth in LV-MAX Production Medium. For further details on our cell line lineage, please see the CTS Viral Production page.
Do you have any guidelines for viral purification under serum free conditions?
For downstream purification of virus, we recommend Tangential Flow Filtration. We do not recommend ultracentrifuge for serum-free conditions to maintain integrity of viral vectors. Please contact cellculturesupport@thermofisher.com for suggested protocol.
Do you have a protocol to detect residual components of the LV-MAX transfection reagent and enhancer?
We can provide protocol guidance for how to detect transfection reagent components under CDA. Please contact cellculturesupport@thermofisher.com for information.
What is the intended claim for these products?
LV-MAX products are intended for research use only while our CTS LV-MAX products are intended for research use or manufacture of cell, gene or tissue-based products. Please refer to individual product for further details on the intended use claim.
What are the major differences between LV-MAX and the CTS LV-MAX products?
Performance between the two systems is equivalent. In contrast to the research use only LV-MAX products, CTS LV-MAX products have an additional intended use for cell and gene therapy applications and complimented with a more robust regulatory support package to enable clinical therapeutic applications. This means that to the best of our ability, we keep our CTS product specifications and release requirements up to date in accordance with the latest regulatory guidance specific for this intended use.
Resources
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Gene therapy brochure
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Cell & Gene Therapy Learning Center
This collection of resources will help you gain a better understanding of cell therapy research.
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*CTS products are manufactured to meet the ancillary material supplier responsibilities for cell-, gene-, and tissue-engineered products. Other aspects of USP <1043> are the responsibility of the end user to assess.
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.